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Eight years of the East African Community Medicines Regulatory Harmonization initiative: Implementation, progress, and lessons learned

Authors:
  • Gwynedd Consultancy Group LLC

Abstract and Figures

Access to essential medicines is a key pillar of any health system seeking to deliver universal health coverage. Science-based, independent regulation of medical products is a critical part of ensuring that only quality essential medicines reach the patients who need them. • In this article, we explore the progress the East African Community's Medicines Regulatory Harmonization (EAC MRH) initiative, launched in 2012, has made toward its goal of improving access to essential medicines. The initiative's initial focus was on registering generic medicines, with a plan to expand to other classes of medical products, as well as to other regulatory functions. • From 2012 to 2017, the timeline for national assessments of medicinal product applications decreased from roughly 24 months to 8-14 months, if products were assessed through the new joint assessment process (involving 2 or more national medicines regulatory authorities). • Since 2015, the initiative has conducted 10 joint product assessment sessions in which 83 medicinal product applications were considered, resulting in the recommendation of 36 products for registration by EAC Partner States. • Overall, the median timeline for a joint assessment, from submission of the application through final decision, has been a little over a year (372 days); 170 of these days represent time used by manufacturers to answer queries. However, the median timeline for a joint assessment in 2019 was only 240 days, indicating that the process has become more efficient. • Shifting from relying on donor support to becoming self-sustaining remains a challenge for the EAC MRH initiative.
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COLLECTION REVIEW
Eight years of the East African Community
Medicines Regulatory Harmonization
initiative: Implementation, progress, and
lessons learned
Jane H. MashingiaID
1
, Vincent Ahonkhai
2
, Noel Aineplan
3
, Aggrey Ambali
4
,
Apollo AngoleID
3
, Mawien Arik
5
, Samvel Azatyan
6
, Peter Baak
5
,
Emmanuel Bamenyekanye
7
, Aimable Bizoza
8
, Chimwemwe ChamdimbaID
4
,
Petra DoerrID
9
, Adam FimboID
10
, Alex Gisagara
8
, Hidaya Hamad
11
, Rachelle HarrisID
12
,
Dan HartmanID
13
, Joseph KabatendeID
8
, Charles KarangwaID
8
, Agnes Sitta KijoID
10
,
Murray LumpkinID
13
, Shani Maboko
10
, David MatleID
10
, Apollo Muhairwe
14
, John
Patrick Mwesigye
1
, Bonaventure Nyabenda
7
, Alexander Schulze
15
, Andreas Seiter
14
,
Gordon Sematiko
3
, Margareth SigondaID
4
, Hiiti Sillo
6
, Burhani SimaiID
11
, Fred SiyoiID
16
,
Stanley SonoiyaID
1
, Paul Tanui
4
, Mike Ward
6
, Felistas YanoID
16
, David MukangaID
13
*
1East African Community Secretariat, Arusha, Tanzania, 2Gwynedd Consultancy, LLC, Philadelphia,
Pennsylvania, United States of America, 3National Drug Authority, Kampala, Uganda, 4African Union
Development Agency–New Partnership for Africa’s Development, Midrand, South Africa, 5Drug and Food
Control Authority, Juba, South Sudan, 6World Health Organization, Geneva, Switzerland, 7Directorate of
Pharmacy, Medicines, and Laboratories, Bujumbura, Burundi, 8Rwanda Food & Drugs Authority, Kigali,
Rwanda, 9Petra Doerr Consulting Ltd., Herznach, Switzerland, 10 Tanzania Medicines and Medical Devices
Authority, Dar Es Salaam, Tanzania, 11 Zanzibar Food & Drug Agency, Zanzibar City, Zanzibar, 12 Harris
Access Consulting Ltd, London, United Kingdom, 13 Bill & Melinda Gates Foundation, Seattle, Washington,
United States of America, 14 World Bank, Washington DC, United States of America, 15 Swiss Agency for
Development and Cooperation, Bern, Switzerland, 16 Pharmacy & Poisons Board, Nairobi, Kenya
*David.Mukanga@gatesfoundation.org
Summary points
Access to essential medicines is a key pillar of any health system seeking to deliver uni-
versal health coverage. Science-based, independent regulation of medical products is a
critical part of ensuring that only quality essential medicines reach the patients who
need them.
In this article, we explore the progress the East African Community’s Medicines Regula-
tory Harmonization (EAC MRH) initiative, launched in 2012, has made toward its goal
of improving access to essential medicines. The initiative’s initial focus was on register-
ing generic medicines, with a plan to expand to other classes of medical products, as
well as to other regulatory functions.
From 2012 to 2017, the timeline for national assessments of medicinal product applica-
tions decreased from roughly 24 months to 8–14 months, if products were assessed
through the new joint assessment process (involving 2 or more national medicines regu-
latory authorities).
Since 2015, the initiative has conducted 10 joint product assessment sessions in which
83 medicinal product applications were considered, resulting in the recommendation of
36 products for registration by EAC Partner States.
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OPEN ACCESS
Citation: Mashingia JH, Ahonkhai V, Aineplan N,
Ambali A, Angole A, Arik M, et al. (2020) Eight
years of the East African Community Medicines
Regulatory Harmonization initiative:
Implementation, progress, and lessons learned.
PLoS Med 17(8): e1003134. https://doi.org/
10.1371/journal.pmed.1003134
Published: August 12, 2020
Copyright: ©2020 Mashingia et al. This is an open
access article distributed under the terms of the
Creative Commons Attribution License, which
permits unrestricted use, distribution, and
reproduction in any medium, provided the original
author and source are credited.
Funding: The preparation of the manuscript was
supported by the Bill & Melinda Gates Foundation.
Competing interests: I have read the journal’s
policy and the authors of this manuscript have the
following competing interests: DH, DM, & ML
declare they are employees of the Bill & Melinda
Gates Foundation, which funds the EAC MRH
initiative.
Abbreviations: AUDA-NEPAD, African Union
Development Agency–New Partnership for Africa’s
Development; BCG, Boston Consulting Group;
BMGF, Bill & Melinda Gates Foundation; CTD,
Common Technical Document; EAC, East African
Community; GMP, good manufacturing practice;
ICH, International Council for Harmonisation of
Overall, the median timeline for a joint assessment, from submission of the application
through final decision, has been a little over a year (372 days); 170 of these days repre-
sent time used by manufacturers to answer queries. However, the median timeline for a
joint assessment in 2019 was only 240 days, indicating that the process has become
more efficient.
Shifting from relying on donor support to becoming self-sustaining remains a challenge
for the EAC MRH initiative.
Introduction
Access to essential medicines is a key pillar of any health system seeking to deliver universal
health coverage. Science-based, independent regulation of medical products is a critical part of
ensuring that only quality essential medicines reach the patients who need them. However,
such regulation needs to be conducted in a transparent, efficient, accountable, and predictable
manner to have a positive impact on public health. National medicines regulatory authorities
(NMRAs) have their mandate codified in national legislations and put into practice by apply-
ing a set of internationally recommended core regulatory functions. According to the World
Health Organization (WHO) [1], NMRAs contribute to promoting and protecting public
health and safety by ensuring that.
medicines are of the required quality, safety, and efficacy;
health professionals and patients have the necessary information to enable them to use medi-
cines rationally;
medicines are appropriately manufactured, stored, distributed, and dispensed;
illegal manufacturing and trade are detected and adequately sanctioned;
promotion and advertising are fair, balanced, and aimed at rational drug use; and
access to medicines is not hindered by unjustified regulatory work.
In 2012, the East African Community (EAC)—a regional economic community consisting,
at that time, of Burundi, Kenya, Rwanda, the United Republic of Tanzania, and Uganda—rec-
ognized that, though its NMRAs were fulfilling many of these important functions, much
room for improvement still existed with regard to improving its citizens’ access to essential
medicines. In particular, the EAC hoped to improve access to medicines by making the mar-
keting authorization application process for manufacturers more efficient by increasing the
speed at which it reviewed applications, without decreasing rigor, and by modernizing its pro-
cesses and procedures. To work toward these goals, it initiated the EAC Medicines Regulatory
Harmonization (MRH) initiative.
The initiative reached a major milestone in 2015, when Roche applied to market 2 oncology
medicines, bevacizumab and trastuzumab, in the EAC. Neither medicine was new. Bevacizu-
mab was first approved by the United States Food and Drug Administration in 2004 and tras-
tuzumab in 1998 [2,3], and both medicines were on WHO’s list of essential medicines [4].
However, neither medicine had been registered in any EAC country. Before the EAC MRH
initiative was established, a company would have had to complete different registration
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Technical Requirements for Pharmaceuticals for
Human Use; IMS, information management
system; ISO, International Organization for
Standardization; MRH, Medicines Regulatory
Harmonization; NMRA, National medicines
regulatory authorities; QMS, quality management
system; SOP, standard operating procedure;
Swissmedic, Swiss Agency for Therapeutic
Products; WHO, World Health Organization.
Provenance: Not commissioned; externally peer-
reviewed.
applications for each EAC country. Thanks to the initiative, however, Roche was able to apply
for a single region-wide joint assessment of the medicines, the first ever performed in the
EAC. The medicines were recommended for registration throughout the region, and using the
positive joint assessment and recommendation, they were registered in mainland Tanzania
within 4 months of application for joint assessment [5]. This represented a substantial
improvement over the 2-year average registration time in the region before the initiative
began. Afterward, the medicines were registered by Kenya and Uganda (although the medi-
cines were eligible for registration in all EAC countries, the manufacturer decided to register
them in only 3). Because of this new regional approach to product assessment, these medicines
were available in EAC countries sooner than they would have been otherwise. This benefited
the patients, who gained earlier access to the medicines; the manufacturer, which was able to
more efficiently register its medicines in multiple countries (while it had patent protection on
the medicines); and the NMRAs of the EAC countries, which saved time and resources by con-
ducting a single joint assessment rather than multiple national assessments.
In this review article, we will further explore what the EAC MRH initiative, which launched
in 2012, has accomplished in its 8 years of existence. In addition to the wealth of personal expe-
rience with the initiative that the authors of this article have, we draw on information from an
evaluation completed in late 2017 by the Boston Consulting Group (BCG), which interviewed
staff from EAC Partner States’ NMRAs and Ministries of Health; industry representatives from
multinational companies and local medicines importers and manufacturers that had used the
new processes; and staff from key stakeholders such as the EAC Secretariat, the African Union
Development Agency–New Partnership for Africa’s Development (AUDA-NEPAD), the
World Bank, donors, and technical partners such as WHO. By sharing the most successful and
challenging aspects of the initiative, we hope to help other regions that are planning similar pro-
grams—and to encourage the community, especially individuals from low- and middle-income
countries, to develop and share their own ideas regarding the harmonization, alignment, and
optimization of regulatory processes and technical standards at a regional level.
Progress toward the major goals of the EAC MRH initiative
As described in an accompanying article in this collection, Coming together to improve access
to medicines:The genesis of the East African Community’s Medicines Regulatory Harmonization
initiative [6], the overarching vision of the EAC’s MRH initiative was to increase the number
of quality medicines registered in the region by (1) simplifying the application process for
manufacturers and (2) increasing the efficiency with which applications were assessed by Part-
ner States—without sacrificing product efficacy, safety, or quality. In pursuit of this vision, the
initiative originally decided to focus on
Developing and implementing
A Common Technical Document (CTD), based on the International Council for Harmo-
nisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) CTD, that
manufacturers could use to register medicines within any EAC Partner State
A common information management system (IMS) for medicines registration that would
link all Partner States, as well as the EAC Secretariat
A quality management system (QMS) in each NMRA, to ensure that each Partner State
carried out regulatory activities in a uniform and rigorous manner
Building the EAC’s regional and national capacity to implement registration processes and
harmonize and align technical standards; and
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Developing and implementing a framework for Partner States to eventually recognize the
regulatory findings and decisions of their neighbors.
Although its initial focus was on registering generic medicines, the plan was for the initia-
tive to later expand to other classes of medical products, such as biosimilars, vaccines, and
medical devices, as well as to other regulatory functions, such as clinical trials oversight and
pharmacovigilance. Finally, the EAC MRH initiative was expected to identify a funding mech-
anism that would allow it to sustain and broaden its regulatory activities after the catalytic
donor support available for the first 5 years expired.
Successes on the way to MRH
The EAC MRH initiative succeeded in increasing the efficiency with which registration appli-
cations for medicines were assessed. From 2012 to 2017, the timeline for national assessments
(those carried out by single NMRAs) decreased from roughly 24 months at baseline (estimated
with the help of past applicants) to 8 to 14 months in Kenya and 10 to 12 months in Tanzania
(range based on median and average timelines) [7]. In Uganda, the timeline decreased from an
estimated 18 months at baseline to 14 to 16 months [7]. Other countries in the EAC did not
assess product dossiers for registration prior to the EAC MRH initiative. Indeed, this is one of
the achievements of the EAC MRH initiative: It has enabled these countries to set up their own
fit-for-purpose marketing authorization systems.
These shorter timelines were possible, in part, because in 2015, the initiative adopted a
modified version of the CTD developed by the ICH. Manufacturers could use this CTD to
apply for registration of medicines in any EAC Partner State. The initiative’s Medicines Evalu-
ation & Registration Working Group, led by Tanzania’s NMRA, created this CTD as part of
the program’s larger mandate of harmonizing technical requirements, standards, and standard
operating procedures (SOPs) for medicines assessment and registration across the region [8].
Because the EAC’s CTD is based on the formats used by ICH and the WHO’s Prequalification
Programme, EAC Partner States can easily leverage dossiers previously submitted to other reg-
ulatory authorities, such as the WHO, US Food and Drug Administration, or European Medi-
cines Agency. With the consent of the applicant, regulatory agencies can enter into
confidentiality agreements with other regulatory agencies to share assessment reports on dos-
siers they have evaluated; however, if the formats used for dossiers are different from the CTD,
it would be cumbersome to follow the reviews undertaken by agencies sharing their reports. In
addition, manufacturers can easily file dossiers across multiple territories if they all use the
same international standards and formats; not having to develop tailored applications saves
the manufacturers significant resources. Between 2015 and 2017 alone, more than 3,500 appli-
cations were submitted to the NMRAs of EAC Partner States using the new CTD format.
These applications were submitted directly to the various NMRAs outside the joint assessment
process. In interviews conducted by BCG, multinational companies reported that the transi-
tion to the new CTD format was easy, as they were already accustomed to preparing dossiers
in this format for other markets. Local companies found the transition to the new CTD format
more challenging, as it was unfamiliar and often more comprehensive than the formats they
had used previously. In general, though, both types of companies reported that the new CTD
format was an improvement, as applicants no longer had to prepare different dossiers for each
country in the EAC.
The EAC MRH initiative also began conducting joint regulatory activities. Since 2015, the
initiative has conducted 10 joint product assessment sessions, in which it has assessed 83
medicinal product applications, resulting in the recommendation of 36 products for registra-
tion by EAC Partner States (Fig 1). For each product subjected to joint assessment, 2 NMRAs
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are assigned to perform an initial assessment and share their findings, which are then dis-
cussed by all EAC NMRAs via joint assessment sessions held by the Medicines Evaluation &
Registration Working Group (Fig 2). Overall, the median timeline for a joint assessment, from
submission of the application through final assessment decision, has been a little over a year
(372 days); 170 of these days represent the time used by manufacturers to answer queries.
However, the median timeline for a joint assessment in 2019 was only 240 days, indicating that
the process has become more efficient.
Once a product has been recommended for registration through the joint assessment pro-
cess, registration by individual NMRAs should be swift, with a target timeline of 3 months or
less. However, as in the example of bevacizumab and trastuzumab described previously, many
manufacturers whose products have undergone joint assessment have decided not to register
those products in all EAC Partner States (Fig 1). Reasons for this failure to register vary. An
applicant may not be ready or desire to establish business in a given country for commercial
reasons, for example. Or an applicant may not register its product in Zanzibar because once a
product is registered in Tanzania, Zanzibar automatically recognizes the registration, so a
Fig 1. Outcomes for the joint assessment pathway of the East African Community’s Medicines Regulatory
Harmonization initiative, from 2015, when the first applications were submitted, through August 2019. (A)
Number of applications submitted, assessed, and recommended for registration. The relative amount of time spent
with the regulator versus the manufacturer (while addressing queries from the regulator) is shown for assessments. (B)
Number of medicines registered by each of the East African Community’s individual national medicines regulatory
authorities, of the 36 recommended to date through the joint assessment pathway. The numbers above each Partner
State’s name represent the range of times elapsing from joint assessment recommendation to product registration.
These ranges include, where relevant, the time that a manufacturer took to submit an application and payment to the
Partner State’s national medicines regulatory authority after receiving a joint assessment recommendation. Some
smaller markets, such as Burundi, have received fewer registration applications from manufacturers following the joint
assessment process. South Sudan, a new member of the initiative, has not yet started to register products and thus is
not shown here.
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second registration is unnecessary. To date, the maximum number of NMRAs that have regis-
tered a single product following joint assessment is 5, and this occurred for only 1 product
(cetuximab). Furthermore, although Tanzania’s rapid approval of bevacizumab and trastuzu-
mab following joint assessment demonstrates what can be accomplished with the new system,
there has been a great deal of variation in the time it takes to finalize national registration.
When manufacturers seek to register products with individual NMRAs after receiving a rec-
ommendation for registration, some have reported significant delays—sometimes of over a
year [9]. The range of time to registration after a positive joint assessment is 60 to 90 days for
the NMRAs of Tanzania and Zanzibar (meeting the 3-month target) and 120 to 180 days for
the NMRAs of Kenya, Rwanda, and Uganda (exceeding the 3-month target). The range of
time to registration for Burundi is 334 to 912 days, though these numbers reflect the registra-
tion of just 2 products. It should be noted that all of the time ranges given include the time that
companies take to submit national applications and pay fees following a joint recommenda-
tion, as well as the time taken by regulators to process national applications.
Meanwhile, joint good manufacturing practice (GMP) inspections began in 2016. First, the
initiative’s GMP Inspection Working Group, led by Uganda’s NMRA, established guidelines
and SOPs for both national and joint inspections of factories in the region, based on WHO
guidelines [10]. These SOPs were used during the 15 joint GMP inspections conducted thus
far, resulting in 14 joint recommendations for approval. Similar to joint product assessments,
joint GMP inspections are assigned to inspectors from 2 NMRAs, who share their findings
with the EAC’s other NMRAs via the GMP Inspection Working Group (Fig 3). Most joint
Fig 2. The joint product assessment pathway of the EAC’s Medicines Regulatory Harmonization initiative. EAC,
East African Community; NMRA, national medicines regulatory authority.
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inspections have been performed on facilities that produce low-cost generic medicines. In
2019, for example, all 6 joint inspections performed to date have been on facilities that produce
generics.
Joint assessments and inspections conferred benefits on both applicants and the EAC’s
NMRAs. As described in the aforementioned examples, using the joint process, companies
seeking to register a medicine in the EAC could undergo fewer assessments and inspections.
Moreover, when the program worked as intended, registration in EAC Partner States pro-
ceeded smoothly, using the same applications and relying upon the information and recom-
mendations from joint assessments or inspections. NMRAs, for their part, were able to work
more efficiently, as the opportunity to rely on findings from joint assessments and inspections
meant they need not perform their own assessments or inspections for every application
received. In addition, joint activities facilitated capacity building and trust building between
the NMRAs acting as assessors or inspectors. Trust was built through staff exchanges between
the agencies of the different countries; the time spent at another’s agency allowed the visiting
staff to learn how their counterparts undertook scientific reviews and regulatory activities.
Also, dossiers were reviewed by assessors from different countries—through this work sharing
and joint report preparation, the staff got to learn from each other and see one another’s exper-
tise; this was also true when staff undertook joint inspections of manufacturing facilities.
Finally, because joint assessments and inspections are generally considered more transparent
and stringent than national assessments and inspections, because of the greater amount of
expertise involved, Partner States tended to be confident in the resulting findings. At the same
Fig 3. The joint good manufacturing process inspection pathway of the EAC’s Medicines Regulatory Harmonization initiative. EAC, East African
Community; NMRA, national medicines regulatory authority.
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time, some manufacturers expressed concern that joint assessments imposed high interna-
tional standards, whereas some national assessments did not [9]. For example, some NMRAs
had historically waived the requirement to demonstrate bioequivalence for certain products
undergoing national assessments, but this requirement was not waived for joint assessments,
because demonstrating bioequivalence is an international best practice.
An original focus of the initiative was using the joint assessment process to help facilitate
access to medicines for the conditions that represent the largest health burdens in the EAC,
such as HIV, malaria, tuberculosis, lower respiratory infections, and diarrheal diseases. It was
thought that the benefits of undergoing joint assessment could be used to entice manufacturers
and importers to focus on these types of medicines. However, most of the products to treat
these conditions are—or will be—eligible for WHO’s Prequalification Programme. Thus, it
became evident that local registration through the WHO Prequalification–NMRA Collabora-
tive Registration Procedure (in which all EAC Partner States participate) was the most efficient
process for bringing these medicines to market. The EAC MRH Steering Committee then
decided to invite manufacturers of certain types of medicines that are not eligible for the
WHO Prequalification Programme, such as anticancer and antihypertensive medicines, to use
the joint assessment process. This attracted a high proportion of these types of applications:
from 2015, when joint assessments began, through 2017, 16% of 49 joint product applications
were for oncology products, and 24% were for cardiovascular disease products.
Under the guidance of a recently convened working group led by Kenya’s NMRA, the ini-
tiative also drafted harmonized guidelines for pharmacovigilance, as well as a pharmacovigi-
lance roadmap and business plan to guide activities in this area. In March 2019, the EAC
Sectoral Council of Ministers approved the EAC Harmonized Compendium of Guidelines for
Pharmacovigilance [11], and the initiative has also announced plans to expand into laboratory
testing of medicines and postmarketing surveillance in the coming years, described in more
detail in an accompanying paper in this collection, Optimizing the East African Community’s
Medicines Regulatory Harmonization initiative in 2020–2022:A Roadmap for the Future [12].
One of the initiative’s most striking successes was its contribution to increased regulatory
capacity in NMRAs across the region. When the initiative began, in 2012, Kenya, Tanzania,
and Uganda had established semiautonomous NMRAs, but Burundi, Rwanda, and Zanzibar
only had departments or boards housed within their ministries of health to regulate medicines.
Today, Rwanda and Zanzibar have full-fledged semiautonomous NMRAs, as does the EAC’s
newest Partner State, South Sudan, and Burundi is expected to gain approval for its own
NMRA in the near future. Joint activities and the initiative’s twinning program (which paired
Zanzibar’s NMRA with Kenya’s, Burundi’s with Tanzania’s, and Rwanda’s with Uganda’s)
have helped the newer NMRAs benefit from the knowledge and expertise of the more mature
NMRAs, while strengthening the relationships between Partner States. In addition, the initia-
tive has overseen trainings dedicated to building regulatory capacity in various functions.
These trainings, carried out by WHO and the Swiss Agency for Therapeutic Products (Swiss-
medic), have focused on topics such as medicines evaluation and registration, GMP, QMS,
IMS, and pharmacovigilance.
MRH: Works in progress
Although beginning to conduct joint activities was a major achievement, stakeholders have
noted several challenges with the first joint assessments performed, including
A lack of transparency regarding timelines, making it difficult for applicants to track their
applications’ progress;
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Inadequate NMRA follow-up to applicants’ questions;
Inadequate applicant follow-up to NMRAs’ questions;
Failure of assessors to screen for errors or omissions early in the process, leading to avoidable
queries later in the process;
Poor communication with technical partners about the scheduling of joint assessments,
making it challenging for the partners to provide support; and
Delays in obtaining national registrations once a joint recommendation had been made.
Similar problems were noted for joint GMP inspections in the BCG evaluation in 2017.
How the initiative addressed these and other problems is described in an accompanying paper
in this collection [12].
Another goal the initiative continues to work toward is implementing a shared IMS that links
all Partner States, as well as the EAC Secretariat. Without an IMS, it is difficult for NMRAs to
track the progress of applications in their own countries, much less in neighboring countries.
Thanks to the initiative, all EAC Partner States now have a functioning IMS, and there is general
agreement that this has boosted efficiency and strengthened cross-department linkages. The
newer NMRAs of Burundi, Rwanda, and Zanzibar, as well as Uganda’s NMRA, chose to create a
novel platform with support from the initiative, whereas Kenya and Tanzania kept their legacy
systems. Ultimately, the platforms are designed to allow as many processes as possible to be con-
ducted online, through a single portal. However, to date, only Kenya’s system allows applications
to be submitted electronically. Moreover, to link Partner States’ IMS platforms to one another,
as well as to the EAC Secretariat, the initiative must develop systems that are interoperable. A
Cooperation Framework was signed in May 2018 by the EAC’s Council of Health Ministers; in
it, Partner States agreed to share information on marketing authorization and GMP certifica-
tions, demonstrating their commitment to data sharing [13]. How this sharing will take place
efficiently in the absence of a linked IMS connecting Partner States remains a challenge.
One last goal still in progress is for each of the EAC’s NMRAs to implement a QMS, to ensure
that its regulatory processes are conducted in a uniform and rigorous manner. One of the most
meaningful ways that NMRAs attempted to confirm the quality of their work was by becoming
International Organization for Standardization (ISO) certified (This is the measure of an
agency’s QMS as judged against ISO standards. Meeting the requirements for ISO certification
is a globally recognized accreditation of the maturity and functionality of the QMS of an organi-
zation, including medical products regulatory agencies). In 2014, the QMS Working Group, led
by Kenya and assisted by WHO and Swissmedic, established a harmonized QMS technical doc-
ument based on the ISO 9001:2008 standard. However, the new ISO 9001:2015 standard was
released shortly after, and EAC countries are now adopting it instead. To date, Kenya, Tanzania,
Zanzibar, and Uganda’s NMRAs are 9001:2015 ISO-certified, and Rwanda and Burundi are cur-
rently working toward 9001:2015 ISO certification. In addition, Tanzania’s NMRA is the first in
Africa to attain designation by WHO as a maturity level 3 (out of a total possible score of 4)
agency, denoting an agency with “a stable well-functioning and integrated system of oversight
for medical products” [14]. Once QMS are in place across the region, Partner States will have
greater confidence in the quality of their neighbors’ work, increasing trust and facilitating reli-
ance on the documents and inspections of their regional NMRA colleagues.
Continuing challenges for the EAC MRH initiative
A major goal of the EAC MRH initiative was to identify and implement a self-sustaining
source of funding, so its activities could continue and even expand after initial catalytic donor
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funding ended, which was initially slated for 2017. Progress in this area has proved difficult.
Originally, the plan was for Partner States to fund a growing portion of initiative activities
starting several years after the program began. Little of such funding materialized, however.
Ultimately, the Bill & Melinda Gates Foundation (BMGF), the UK Department for Interna-
tional Development, and the US Department of Treasury contributed almost US$25 million to
the initiative between 2012 and 2017, with US$9 million directly supporting EAC activities
and US$10 million supporting the activities of partners, such as WHO, World Bank, and
AUDA-NEPAD, who were providing technical, financial, and advocacy assistance (Fig 4).
Since then, the EAC Secretariat has received another $500,000 in support for the initiative
from BMGF, as well as $750,000 from USAID to support pharmacovigilance work. At present,
the well-established NMRAs of Kenya, Tanzania, and Uganda do support some program activ-
ities. For example, they fully cover the costs of their staff taking part in joint GMP inspections
and also host initiative-related meetings. Heads of agencies have now also committed to cover-
ing most meeting costs, with donor funding covering only the costs of flying to face-to-face
meetings going forward. The EAC MRH Steering Committee has indicated its commitment to
transitioning to an EAC Medicines Agency- and fee-based funding system, but this process
has not yet begun; future plans to address funding and other challenges are described in an
accompanying article in this collection [12].
Another continuing challenge to conducting program activities has been bureaucratic inef-
ficiencies. For example, the program’s donor trust fund is currently managed by the World
Bank, which disburses funds to the EAC Secretariat, which then allots funds for program activ-
ities, many of which are conducted by NMRAs. Though both the World Bank and EAC Secre-
tariat emphasize that their goal is to disburse funds as quickly as possible once they have
received the required documentation, NMRAs report that complying with 2 sets of require-
ments is cumbersome and that, in some cases, delayed payments have led to joint activities
being postponed or NMRAs having to advance money to conduct program activities. Another
example of bureaucratic inefficiency is that, initially, the EAC Secretariat was responsible for
hiring the officers stationed at NMRAs who were tasked with conducting key initiative
Fig 4. Breakdown of donor funding for the EAC MRH initiative, 2012–2017. EAC MRH Phase 1 lasted from July
2012 through July 2017, and Phase 2, which partially overlapped with Phase 1, lasted from July 2016 through
December 2017. Light green represents EAC MRH–specific funding, medium green represents funding for partners,
gray represents funding for other MRH initiatives (such as those in the Economic Community of West African States,
South African Development Community, and Intergovernmental Authority on Development regions), and dark green
represents total funding for the initiative. AMRH, African Medicines Regulatory Harmonization; AUDA-NEPAD,
African Union Development Agency–New Partnership for Africa’s Development; EAC MRH, East African
Community’s Medicines Regulatory Harmonization; WHO, World Health Organization.
https://doi.org/10.1371/journal.pmed.1003134.g004
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activities. If one of these officers was not meeting their responsibilities at the NMRA, the Head
of that NMRA had a difficult time holding him or her accountable, because the officer
answered to the EAC Secretariat. This has been addressed by having project officers specifi-
cally focused on these joint activities appointed by and responsible to the individual heads of
the EAC NMRAs.
Still another example of an inefficiency is that even after undergoing the joint assessment
process, manufacturers must by law submit an application and fee to the NMRA of each EAC
Partner State in which they want to register a medicine. The same goes for joint GMP inspec-
tions. The lack of a simple region-wide application process may discourage some medicines
manufacturers and importers from swiftly registering their products throughout the EAC,
especially in those Partner States that represent smaller markets.
One of the barriers to region-wide assessments and inspections is the lack of a binding legal
framework that would require EAC Partner States to recognize the regulatory decisions of their
neighbors. Originally, the initiative’s ultimate goal was for all NMRAs to formally commit to
recognizing one another’s regulatory decisions. To date, however, the only such agreement is a
unilateral one in which Zanzibar’s NMRA agrees to recognize the regulatory decisions of Tan-
zania’s NMRA. As mentioned, the EAC’s Council of Health Ministers signed a Cooperation
Framework in May 2018, and this framework includes an agreement by Partner States to make
regulatory decisions based on the outcomes of joint activities. This new agreement is nonbind-
ing, however, and whether and how it will facilitate mutual recognition remains to be seen.
Given the importance of trust in Partner States collaborating with their regional NMRA
partners and relying on each other’s work, the different capacities of the EAC’s NMRAs
remain a challenge. The NMRAs of Burundi, Rwanda, and Zanzibar have made great strides in
5 short years, as has the NMRA of South Sudan, which joined the EAC in 2016. Burundi, for
example, has received 630 applications since it began registering medicines in 2016, resulting
in the registration of 216 medicines. Even so, the EAC’s more mature NMRAs sometimes need
more assurance in the quality of their newer peers’ assessments and inspections. The lack of
trust between NMRAs is not solely driven by experience level, however, as more mature
NMRAs sometimes refuse to rely fully on each other’s decisions. To address some of these
problems, Partner States have agreed to recognize a manufacturing site’s certifications if they
come from 2 of the 3 most mature NMRAs in the EAC (those of Kenya, Tanzania, and
Uganda). In general, however, even the less mature NMRAs would often rather improve their
own capacity than rely on the work of more mature NMRAs, limiting opportunities for regula-
tory specialization, efficiency, and cooperation.
Staff turnover and understaffing also remain a challenge for the initiative. Since 2012, staff
turnover in key leadership roles has been high. The enthusiasm and experience crucial to the
initiative’s success wax and wane with changes in staff, posing a problem for the program’s
continuity. Turnover also represents an important problem at the technical staff level for
NMRAs, especially those with fewer resources. Burundi’s NMRA, for example, has trained 4
pharmacists to participate in product assessments since the initiative began, but all have left
the agency for other missions, including positions in other ministerial departments or at inter-
national nongovernmental organizations. Having to constantly train new hires when trained
staff leave, either because they have been assigned to other duties or because the private sector
is eager to hire these individuals at higher salaries, is a major drain on the resources of the
NMRAs and makes it difficult to conduct daily tasks smoothly. Activities associated with the
EAC MRH initiative, which are often still perceived by NMRA staff as “extra” duties, are espe-
cially vulnerable to disruption.
Finally, many participants in the initiative believe that NMRAs, and especially the Heads of
NMRAs, have yet to fully take up the mantle of leadership. To date, the EAC Secretariat, and
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sometimes program partners, have tended to shape the initiative’s agenda. Heads of NMRAs
have expressed a desire for greater involvement in defining program priorities, as they are
most familiar with the needs of their organizations and the health situations in their countries.
Furthermore, leadership at the national level is critical to ensure that regulatory harmonization
and optimization activities take place efficiently and become part of the everyday workflow at
NMRAs. In particular, enthusiastic support by the Heads of NMRAs is needed to convince
staff that the short-, medium-, and long-term benefits of regional cooperation outweigh the
challenges. To nurture this type of leadership, the Heads of NMRAs have recently started con-
vening their own meetings, in which they can candidly discuss future goals with one another
and formulate work plans. This is a key step in ensuring that the initiative continues to grow
and improve.
Conclusion
In its pilot phase, the EAC’s MRH initiative reduced the amount of time it took to register
medicines in individual countries by about half. It did so by instituting a suite of regulatory
standards and processes aligned across the region, as well as by building the capacity of all its
Partner States’ NMRAs to engage in regulatory activities. Thanks to the initiative, some medi-
cines are also now being assessed jointly by the NMRAs of all EAC Partner States, helping to
set the stage for a future in which a company can file a single application to market a product
throughout the entire EAC. Joint GMP inspections are now being conducted as well, further
contributing to regulatory efficiency in the region. There is more trust among and between
experts in the region. However, the initiative still has much work to do, including shifting
from relying on donor support to becoming self-sustaining, optimizing cooperation between
Partner States with very different levels of resources and experience, and moving toward a
more transparent system that is easier for applicants to navigate. In an accompanying article in
this collection, Optimizing the East African Community’s Medicines Regulatory Harmonization
initiative in 2020–2022:A Roadmap for the Future [12], we will describe the EAC’s plans for
the next 3 years, as it seeks to learn from the lessons of the pilot phase and transition from a
pilot project to an efficient, transparent, accountable, and permanent feature of the EAC regu-
latory landscape, including an expansion to pharmacovigilance.
Acknowledgments
The authors thank Kristin Harper, PhD, of Harper Health & Science Communications, LLC,
for providing writing and editorial support in accordance with Good Publication Practice
guidelines. They also thank BCG, for its help with gathering and analyzing data.
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... With the launch of the EAC-MRH programme, the EAC authorities have made substantial progress in reducing timelines for registration of medical products using the joint review process. A study of the EAC-MRH pilot phase (2012-2017) by Mashingia and colleagues found that registration timelines were reduced from 24 months to 8-12 months for products reviewed using this process (Mashingia et al., 2020). ...
... The median time for joint assessment in 2019 was reported to have decreased to 240 working days, demonstrating that the EAC joint assessment process was becoming more efficient (Mashingia et al., 2020). In the same study, registration timelines at the national level were reduced from 24 months to 8-14 months during the 2012-2017 time period (Mashingia et al., 2020). ...
... The median time for joint assessment in 2019 was reported to have decreased to 240 working days, demonstrating that the EAC joint assessment process was becoming more efficient (Mashingia et al., 2020). In the same study, registration timelines at the national level were reduced from 24 months to 8-14 months during the 2012-2017 time period (Mashingia et al., 2020). Giaquinto and colleagues also confirmed that one of the strengths of this initiative was the implementation of the joint assessment and work-sharing procedure with the introduction of the submission of one dossier by applicants to all EAC authorities (Giaquinto et al., 2020). ...
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Background: For almost a decade, the East African Community has implemented the Medicines Regulatory Harmonization (EAC-MRH) programme among its member states to harmonise technical requirements and standards for medical products regulation, jointly conduct scientific review of medical product dossiers to assess safety, efficacy and quality, inspect pharmaceutical manufacturing sites and streamline decision-making processes. This initiative enables the cost-effective use of limited resources and efficient and effective delivery of regulatory services to be determined, thus instilling transparency and accountability in all stakeholders, optimising the pharmaceutical market and economic development and improving access to safe, high-quality, effective medicines in the region. The aim of this study was to evaluate the effectiveness and efficiency of the current operating model of the EAC-MRH initiative, including challenges faced and to identify opportunities for improvement. Methods: The Process Effectiveness and Efficiency Rating (PEER) questionnaire, which was used to identify the benefits, challenges, and suggestions for improving performance of EAC-MRH initiative, was completed by assessors representing seven EAC authorities in the joint assessment procedure. Semi-structured interviews were also carried out to validate the responses. Results: This initiative has been of considerable value as it moves toward achieving its main objectives of shorter timelines for approval of medicines, information sharing among regulators and capacity building for assessments, resulting in quicker access and increased availability of medicines for patients in the region. However, the key challenges identified that have hindered effectiveness and efficiency were the lack of a centralised submission and tracking system; inadequate human resources, manufacturers’ failure to submit the exact same dossier to all countries of interest; lack of an integrated information management system; lack of information on national medical regulatory authority or EAC websites; and challenges in monitoring and tracking assessment reports. Conclusion: The use of a robust information technology system for the central tracking of EAC products is essential to address the identified challenges and improve regulatory effectiveness and efficiency. One central point for payment is needed to expedite the process and to ensure transparency and the availability of information on decision making on national and regional websites. Other key strategies for enhancement include improving the capacity of assessors, work and information sharing and a coordination mechanism for the regional joint assessment, with the eventual establishment of a regional medicine agency.
... The International Standards Organization (ISO) certification is a globally recognized accreditation of the maturity and functionality of the QMS of an organization. [36]. ...
... The EAC regulatory harmonization experience has enhanced regulatory science by increasing the rigour of the review process, with subsequent higher quality standards than national procedures. In turn, this has reduced the overall regulatory burden and led to less duplication of efforts [36,39,40]. These contribute to the strengthening of the capacity of the NMRAs in expedition of the assessments of priority medicines and filtering out of substandard or falsified products [38]. ...
... With a resultant increase in the number of received applications as observed in Kenya, Tanzania Key: ✓ = fully functional; ✓✓ = fully functional and integrated to National Revenue Authority; ✓✓✓ = fully functional and integrated to e-banking and/or Mobile money; ✓✓✓✓ = fully functional and reports customized according to the national and regional needs; ✕ = non-functional; NA = not applicable (Source: EAC Secretariat MRH Project Progress Report, 2015 mainland and Uganda. The ISO certification will also increase confidence in the quality of NMRAs work, increasing trust and facilitate reliance on registration and inspection processes as viewed by peer agencies in the region and across the continent [36]. It is important to note that ISO certification of the NMRAs is one of drivers of a robust medicines regulatory system. ...
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Background Limited capacity to regulate medical products is associated with circulation of products which do not meet standards of quality, safety and efficacy with negative public health and economic outcomes. This study focused on assessing the effect of the East African Community (EAC) medicines regulatory harmonization initiative on the capacity of national medicines regulatory agencies, with a focus on registration and inspection systems. Methods An exploratory mixed-method design using both qualitative and quantitative data to access data from six national medicines regulatory authorities (NMRAs) and the EAC Secretariat. Data was collected using a combination of semi-structured interviews, questionnaires, and checklists for the period 2010/11–2015/16 with 2010/11 data serving as baseline. Heads of NMRAs, regulatory and monitoring and evaluation experts, and the EAC Secretariat Project Officer were enrolled in the study. A set of 14 indicators grouped into 6 categories were used to assess NMRAs performance. Results Policy and legal frameworks provide a foundation for effective regulation. Collaboration, harmonization, joint dossier reviews and inspections of manufacturing sites, reliance and cooperation are key factors for building trust and capacity among NMRAs. Five out of six of the EAC Partner States have comprehensive medicines laws with autonomous NMRAs. All the NMRAs have functional registration and good manufacturing practice inspection systems supported by regional harmonised guidelines for registration, inspection, quality management and information management systems with four NMRAs attaining ISO 9001:2015 certification. Conclusions The EAC regulatory harmonization initiative has contributed to improved capacity to regulate medical products. The indicators generated from this research can be replicated for evaluation of similar initiatives across and beyond the African continent and contribute to public health policy.
... Evaluation of QMS implementation data from the EAC Partner States NMRAs indicated different levels of implementation as indicated in Table 5. However, currently the NMRAs in Kenya, Tanzania mainland, Uganda and Zanzibar are ISO 9001:2015 certi ed, while Rwanda and Burundi NMRAs are working towards the certi cation [36]. Functional Information Management Systems: One of the objectives of the EAC MRH is to have all the Partner States' NMRAs implementing a common IMS for medicines registration, which is linked in all Partner States and the EAC Secretariat. ...
... The EAC regulatory harmonization experience has enhanced regulatory science by increasing the rigour of the review process, with subsequent higher quality standards than national procedures. In turn, this has reduced the overall regulatory burden and led to less duplication of efforts [36,39,40]. These contribute to the strengthening of the capacity of the NMRAs in expedition of the assessments of priority medicines and ltering out of substandard or falsi ed products [38]. ...
... With a resultant increase in the number of received applications as observed in Kenya, Tanzania mainland and Uganda. The ISO certi cation will also increase con dence in the quality of NMRAs work, increasing trust and facilitate reliance on registration and inspection processes as viewed by peer agencies in the region and across the continent [36]. It is important to note that ISO certi cation of the NMRAs is one of drivers of a robust medicines regulatory system. ...
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... The EAC regulatory harmonization experience has enhanced regulatory science by increasing the rigour of the review process, with subsequent higher quality standards than national procedures. In turn, this has reduced the overall regulatory burden and led to less duplication of efforts [33,36,37]. These contribute to the strengthening of the capacity of the NMRAs in expedition of the assessments of priority medicines and ltering out of substandard or falsi ed products [35]. ...
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Introduction The common technical document (CTD) format harmonised the requirements for the registration of medicines, which had traditionally differed from country to country, making it possible for countries to collaborate and conduct joint reviews of applications. One such collaborative medicines registration initiative is the Southern African Development Community ZaZiBoNa, established in 2013. A recent study was carried out with the nine active member regulatory authorities of the ZaZiBoNa to determine their views on its operational effectiveness and efficiency. Having obtained the authorities’ views, the aim of this study was to evaluate the effectiveness and efficiency of the current operating model of the ZaZiBoNa initiative including the challenges it faces as well as identifying opportunities for improvement from the applicants’ perspective. Methods Applicants who had submitted registration/marketing authorisation applications for assessment under the ZaZiBoNa initiative during 2017–2021 were recruited into the study. Data was collected in 2021 using the Process, Effectiveness and Efficiency rating questionnaire (PEER-IND) developed by the authors. The questionnaire was completed by a representative responsible for ZaZiBoNa submissions in each company. Results The pharmaceutical industry was of the view that the ZaZiBoNa initiative has achieved shorter timelines for approval of medicines, resulting in increased availability of quality-assured medicines for patients in the SADC region. Harmonisation of registration requirements and joint reviews have reduced the workload for both the pharmaceutical industry and the regulatory authorities. Some of the challenges identified were the lack of a centralised submission and tracking system, and the lack of information for applicants on the process for submission of ZaZiBoNa dossiers/applications in the individual countries, including contact details of the focal person. The establishment of a regional unit hosted in one of the member countries to centrally receive and track ZaZiBoNa dossiers/applications was identified as the best strategy for moving forward in the interim with the long-term goal being the establishment of a regional medicines authority. Conclusion There was consensus between the pharmaceutical industry and the regulatory authorities as to the way forward to improve the effectiveness and efficiency of the ZaZiBoNa initiative. Implementation of the recommendations identified in this study will lead to enhanced regulatory performance.
... The EAC MRH initiative was innovative in many ways, particularly in its decentralized structure, emphasis on work-sharing, and regulation through reliance driven by trust and goodwill. In the next paper in this Collection, "Eight years of the East African Community Medicines Regulatory Harmonization initiative: Implementation, progress, and lessons learned" [18], we will describe what this innovative approach allowed the initiative to accomplish, including its most significant achievements and its biggest challenges. ...
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... Work-sharing or joint reviews involves the participation of 2 or more regulatory agencies such as the Southern African Development Community (SADC) 13 and the East African Community. 14 The global access mechanisms such as EUM4All 15 or the Swissmedic Marketing ...
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... Previous evaluations of regulatory work have been published. 8,[14][15][16][17] We provide an updated review with a focus on medical device regulation in the 14 member countries of the College of Surgeons of East, Central, and Southern Africa (COSECSA). 18 COSECSA is the largest surgical training institution in sub-Saharan Africa, with a diverse international surgical membership who commonly use a wide range of medical devices. ...
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Effective regulatory frameworks, harmonized to international standards, are critical to expanding access to quality medical devices in low- and middle-income countries. This review provides a summary of the state of medical device regulation in the 14 member countries of the College of Surgeons of East, Central, and Southern Africa (COSECSA) and South Africa. Countries were categorized according to level of regulatory establishment, which was found to be positively correlated to gross domestic product (GDP; rs=0.90) and years of freedom from colonization (rs=0.60), and less positively correlated to GDP per capita (rs=0.40). Although most countries mandate medical device regulation in national legislation, few employ all the guidelines set forth by the World Health Organization. A streamlined regulatory process across African nations would simplify this process for innovators seeking to bring medical devices to the African market, thereby increasing patient access to safe medical devices.
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Introduction ZaZiBoNa, the work-sharing initiative in the Southern African Development Community (SADC) that has been in operation for 8 years has successfully assessed over 300 dossiers/applications, with an overall median time to recommendation of 12 months. All 16 SADC countries participate in the initiative as either active or non-active members. While the successes of ZaZiBoNa are evident, some challenges still exist. The aim of this study was to solicit the views of the participating authorities on the effectiveness and efficiency of the current operating model of the ZaZiBoNa initiative. Methods Data were collected in 2021 using the Process, Effectiveness and Efficiency Rating (PEER) questionnaire developed by the authors. The questionnaire was completed by the focal person in each country and approved by the head of the authority. Results ZaZiBoNa serves as a platform for work sharing, information exchange, capacity building and harmonisation of registration requirements. One of the benefits to regulators has been the improvement in the capacity to conduct assessments. Manufacturers have benefited from compiling one package (modules 2–5) for the initial submission as well as a single response package to the consolidated list of questions, which saves time and resources. Respondents were of the view that patients have benefited as the ZaZiBoNa has contributed to an improved availability and accessibility to quality-assured medicines. Some of the challenges identified were the inadequacy of resources and differences in time to the implementation of ZaZiBoNa recommendations by the individual countries. The establishment of a regional unit hosted in one of the member countries to enable centralised submission and coordination was identified as the best strategy to improve the effectiveness and efficiency of the initiative in the interim, with the long-term goal being the establishment of a regional medicines authority. Conclusion The study identified the strengths of the ZaZiBoNa initiative as well as the opportunities for improvement. The recommendations made would further strengthen this initiative.
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The medicines regulatory landscape in Africa is undergoing transformation with at least two countries having National Medicines Regulatory Authorities (NRAs) that operate at World Health Organization (WHO) maturity level 3. However, this represents the exception as over 90% of African NRAs have limited capacity to perform core medicine regulatory functions, have a shortage of competent regulatory professionals, have high staff turnover, lack diversity of scientific expertise, and have staffing shortages relative to the high workload. A systematic approach to developing the regulatory workforce is therefore crucial to addressing the existing shortfalls in regulatory capacity, particularly at this time when efforts are underway to operationalise the African Medicines Agency (AMA). In this article, initiatives that are building African NRAs' regulatory capacity and developing their workforce are reviewed in preparation for work to be conducted by the AMA. We found that the African Medicines Regulatory Harmonisation (AMRH) initiative has been at the forefront of capacity building and workforce development mainly through the designation of specialised Regional Centres of Regulatory Excellence and the implementation of medicines regulatory harmonisation initiatives in regional economic communities. In addition, some NRAs within high-income countries and trusted institutions have been supporting regulators in low-income countries with registration assessments and facilitating access to quality-assured medical products through their stringent review procedures (SRPs). Capacity building has subsequently been facilitated through this active involvement of African regulators in SRPs. This article also provides recommendations for further capacity building and workforce development.
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Independent, science-based regulation of medical products is a critical part of ensuring quality healthcare. When conducted in a transparent, science-based, efficient, accountable, and predictable manner, it can help ensure access to quality products that patients need. • Several factors determine access to medicines, including treatment policy, pricing, and procurement, along with regulatory activities. Delays in regulatory filing and registration contribute to delays or lack of access to essential medicines in many African countries. • We describe the solution to this problem developed by the East African Community (EAC) and launched in 2012: The EAC Medicines Regulatory Harmonization (MRH) initiative. • Through the MRH initiative, the EAC hoped to increase the number of quality medicines that it registered by simplifying the application process for manufacturers. It also aimed to increase the speed at which it reviewed applications without decreasing rigor, by modernizing assessment processes and procedures. • The EAC MRH initiative is innovative in many ways, particularly in its decentralized structure, emphasis on work-sharing, and regulation through reliance driven by trust and goodwill.
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• The East African Community (EAC)’s Medicines Regulatory Harmonization (MRH) initiative was created to improve access to quality, safe medicines in the region by simplifying the regulatory process while maintaining a high level of rigor. Building on lessons learned since its launch in 2012, the EAC MRH initiative has created a Roadmap for the Future. • The capacity to monitor and reports adverse drug reactions is key for patients’ safety. Therefore, going forward, drug safety and quality surveillance will be a priority for the EAC MRH initiative. • In the future, other key success factors for the initiative will include establishing a cadre of regional technical officers (RTOs), a Cooperation Framework Agreement between the national medicines regulatory authorities (NMRAs) of EAC Partner States, and a sustainable funding mechanism for regional assessment. • Widening the scope of medical products considered (and focusing on those not eligible for the World Health Organization [WHO]’s Prequalification Programme) will also add value to the EAC MRH initiative. • Implementing the EAC MRH initiative’s agreed upon roadmap will lead to a stronger, more efficient, and more accountable region-wide regulatory system, thus improving access to quality, safe medicines for EAC residents. Copyright: © 2020 Arik et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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Background Medicines regulatory harmonization has been recommended as one way to improve access to quality-assured medicines in low- and middle-income countries. The rationale is that by lowering barriers to entry more manufacturers will be enticed to enter the market, while the capacity at the national medicines regulatory authorities is strengthened. The African Medicines Regulatory Harmonization Initiative, agreed in 2009, is developing regional platforms with harmonized regulatory procedures for the registration of medicines. The first region to implement medicines regulatory harmonization was the East African Community (EAC). The harmonization was based on the existing EAC Free Trade Agreement, which officially launched the free movement of goods and services in 2010. Methods and findings In this study we conducted semi-structured interviews and performed document reviews. The main target group for our interviews was pharmaceutical companies. We interviewed 18 companies, including 64% of the total companies who had experienced the EAC joint product assessment procedure, and two EAC-based national medicines regulatory authorities. We found that generally pharmaceutical companies are supportive of the African-based MRH efforts and appreciative of the progress being achieved. However, many companies are now hesitant to use the joint product assessment procedure until efficiency improvements are made. Common frustrations were the length of time to receive the actual marketing authorization; unexpectedly higher quality standards than national procedures; and challenges in getting all EAC countries to recognize EAC approvals. Smaller, less attractive markets have not yet become more attractive from a corporate perspective, and there is no free trade of pharmaceuticals in the EAC region. Conclusions Pharmaceutical companies agree that medicines regulatory harmonization is the way forward. However, regulatory medicines harmonization must actually result in quicker access to the harmonized markets for quality-assured medicines. At this time, improvements are required to the current EAC processes to meet the vision of harmonization.
EAC Medicines Regulatory Harmonization Program: End-Term Evaluation
  • Boston Consulting Group
Boston Consulting Group. EAC Medicines Regulatory Harmonization Program: End-Term Evaluation. 2017.