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Coming together to improve access to medicines: The genesis of the East African Community’s Medicines Regulatory Harmonization initiative

Authors:
  • Tanzania Food and Drugs Authority

Abstract and Figures

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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COLLECTION REVIEW
Coming together to improve access to
medicines: The genesis of the East African
Community’s Medicines Regulatory
Harmonization initiative
Hiiti Sillo
1
, Aggrey Ambali
2
, Samvel Azatyan
1
, Chimwemwe ChamdimbaID
2
,
Eliangiringa KaaleID
3
, Joseph KabatendeID
4
, Murray LumpkinID
5
, Jane H. MashingiaID
6
,
David MukangaID
5
*, Bonaventure Nyabenda
7
, Gordon SematikoID
8
,
Margareth SigondaID
2
, Burhani SimaiID
9
, Fred SiyoiID
10
, Stanley Sonoiya
6
, Mike Ward
1
,
Vincent Ahonkhai
11
1World Health Organization, Geneva, Switzerland, 2African Union Development Agency–New Partnership
for Africa’s Development, Midrand, South Africa, 3School of Pharmacy, Muhimbili University of Health and
Allied Sciences, Dar es Salaam, Tanzania, 4Rwanda Food and Drugs Authority, Kigali, Rwanda, 5Bill &
Melinda Gates Foundation, Seattle, Washington, United States of America, 6East African Community
Secretariat, Arusha, Tanzania, 7Directorate of Pharmacy, Medicines, and Laboratories, Bujumbura,
Burundi, 8National Drug Authority, Kampala, Uganda, 9Zanzibar Food and Drug Agency, Zanzibar City,
Zanzibar, 10 Pharmacy & Poisons Board, Nairobi, Kenya, 11 Gwynedd Consultancy, LLC, Philadelphia,
Pennsylvania, United States of America
*David.Mukanga@gatesfoundation.org
Summary points
Independent, science-based regulation of medical products is a critical part of ensuring
quality healthcare. When conducted in a transparent, science-based, efficient, account-
able, 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 registra-
tion 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 medi-
cines 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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OPEN ACCESS
Citation: Sillo H, Ambali A, Azatyan S, Chamdimba
C, Kaale E, Kabatende J, et al. (2020) Coming
together to improve access to medicines: The
genesis of the East African Community’s Medicines
Regulatory Harmonization initiative. PLoS Med
17(8): e1003133. https://doi.org/10.1371/journal.
pmed.1003133
Published: August 12, 2020
Copyright: ©2020 Sillo 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: DM and ML are
employees of the Bill & Melinda Gates Foundation
which funds the EAC MRH initiative.
Abbreviations: AMRH, African Medicines
Regulatory Harmonization; AUDA-NEPAD, African
Union Development Agency–New Partnership for
Africa’s Development; EAC, East African
Community; FDA, United States Food and Drug
Administration; GMP, good manufacturing
practice; ISO, International Organization for
Introduction
When tenofovir disoproxil fumarate (TDF) was approved by the United States Food and Drug
Administration (FDA) in October 2001, it soon became an important treatment for HIV. It
was the first novel antiviral agent approved in 6 years [1], and thanks to its favorable safety
profile (it was associated with fewer and less frequent adverse events compared to the other
antiretroviral drugs available at the time), it was especially important for individuals who
could not tolerate the toxicity of the regimens then in current use [2]. Although TDF quickly
became a treatment mainstay in the US and Europe, in early 2006 Me
´decins sans Frontières
reported that the medicine’s manufacturer had only registered it for use in 5 sub-Saharan Afri-
can countries: Gambia, Kenya, Rwanda, Uganda, and Zambia [3]. Even in the relatively large
market of South Africa, the manufacturer did not apply for registration until late 2005 [3].
Streamlined regulatory systems can help encourage manufacturers to register their medicines
in more countries and can minimize delays in approval. Independent, science-based regula-
tion of medical products is a critical part of ensuring quality healthcare and, when conducted
in a transparent, science-based, efficient, accountable, and predictable manner, it can help
ensure access to quality products that patients need and can have a very positive impact on
public health. When, however, regulation is not conducted in this manner, it can be a hin-
drance to such access and have a negative impact on public health. Of course, product registra-
tion/approval is only one step in a patient being able to access a needed quality medication;
several important factors determine access to medicines, including treatment policy, pricing,
and procurement, along with regulatory submission and approvals. However, delays in regula-
tory filing and registration contributed to TDF being “virtually unavailable” in many African
countries for years [4]. Unfortunately, the delay between TDF’s approval in the US and its
availability in many African countries is not unusual. An average of 4 to 7 years elapses
between the first regulatory submission for a medicine—usually in a high-income country
such as the US—and its approval in sub-Saharan African countries [5].
A number of factors, including policy recommendations and financing, play an important
role in determining access to medicines in sub-Saharan Africa. However, a major driver of
delays is the reluctance of medicines manufacturers to spend the time, effort, and expense nec-
essary to register their products in each of Africa’s countries. To market their products, com-
panies must submit lengthy applications to national medicines regulatory authorities
(NMRAs), each of which typically has its own requirements and fees. Furthermore, the regis-
tration process often lacks transparency, with no clear timeline or accountability. In a 2012
survey, the majority of representatives from African pharmaceutical companies indicated that
technical issues related to registration were problematic [6]. Paired with the fact that medicines
manufacturers often view the potential profits for any one African country as relatively small,
it is clear why the registration of new products has often been delayed, or even neglected
entirely, in sub-Saharan Africa [7].
Regulators and policymakers throughout Africa have long recognized that improving the
medicines registration process is essential for improving health outcomes. For example, Afri-
can countries must contend with 75% of the world’s HIV/AIDS cases and 90% of its malaria
deaths, and access to quality versions of the newest and most effective medicines is key in treat-
ing these infections [8], as well as in disease control strategies. Access to quality medicines is
equally important for treating noncommunicable diseases, such as cardiovascular disease, dia-
betes, and cancer, which are predicted to overtake infectious diseases as the leading causes of
death in Africa by 2030 [8]. To illustrate the power of improving regulatory efficiency, PATH
recently estimated the effect of accelerating registration and scale-up for just 2 emerging medi-
cines—one aimed at preventing postpartum hemorrhage and the other at treating pneumonia
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Standardization; MRH, Medicines Regulatory
Harmonization; NMRA, national medicines
regulatory authority; PAP, Pan-African Parliament;
REC, regional economic community; Swissmedic,
Swiss Agency for Therapeutic Products; TDF,
tenofovir disoproxil fumarate; WHO, World Health
Organization.
Provenance: Not commissioned; externally peer-
reviewed.
in children under the age of 5 years [9]. They found that speeding up time to patient access for
these 2 medicines by just 2 years could save more than 23,000 lives in eastern and southern
Africa. Optimizing the registration process has become increasingly important as Africa’s
pharmaceutical market continues to grow, increasing in value from US$4.7 billion in 2003 to
US$20.8 billion in 2013 and projected to reach US$40 billion to US$65 billion by 2020 [10].
In this article, we describe the solution to this problem developed by the East African Com-
munity (EAC), a regional economic community (REC) composed of Burundi, Kenya, Rwanda,
South Sudan, Tanzania, and Uganda. In 2012, the EAC launched a region-wide Medicines
Regulatory Harmonization (MRH) initiative, intended as a 5-year pilot for the broader African
Union’s African Medicines Regulatory Harmonization (AMRH) initiative. In describing how
the EAC MRH initiative moved from idea to reality, we hope to give other regions interested
in instituting similar programs insight into important issues to consider, roadblocks likely to
arise, and possible solutions for moving forward. We also hope that sharing the story of the ini-
tiative’s beginning will generate new interest in and ideas about addressing regulatory ineffi-
ciencies that hinder access to quality medicines in low- and middle-income countries.
The genesis of the EAC’s MRH initiative
By the first decade of the new millennium, the need for technical harmonization and process
optimization in regulating medicines had been recognized across the African continent. On the
one hand, such harmonization and optimization would help incentivize medicines manufactur-
ers to register their products in African countries, by decreasing the complexity of the applica-
tion process [11]. On the other hand, harmonization could help NMRAs work more efficiently
by allowing them to rely on their neighbors’ work when making their own regulatory decisions,
thus minimizing duplicate assessments and inspections [11]. By freeing up time and resources
in this way, NMRAs could process applications faster, speeding access to new products and
focusing their resources on the public health issues that would deliver the most added value.
Two events during this period provided a foundation for action. In 2007, the Conference of
African Ministers of Health and the African Union’s Heads of State and Government endorsed
a Pharmaceutical Manufacturing Plan for Africa, which called for regulatory harmonization
[8]. Then, in 2008, many African regulators met at the Thirteenth International Conference of
Drug Regulatory Authorities, held in Bern, Switzerland, to discuss opportunities for coopera-
tion. At this conference, the regulators requested that the World Health Organization (WHO)
use its convening authority to bring countries together and use its technical norms and stan-
dards authority to drive the regulatory harmonization agenda forward. These WHO mandates
are granted by the World Health Assembly and the International Conference of Drug Regula-
tory Authorities. Historically, many countries have relied on WHO for technical assistance in
many fields, including regulatory capacity building, and requests for assistance are presented
to WHO via both formal and informal WHO member state mechanisms, such as the request
presented at this conference.
Planning for continent-wide MRH began in earnest in 2009 (Fig 1). In February of that
year, the African Union Development Agency–New Partnership for Africa’s Development
(AUDA-NEPAD) and the Pan-African Parliament (PAP) cohosted a meeting. There, policy-
makers and regulators from almost 40 African countries endorsed the objectives of a consor-
tium dedicated to pursuing an AMRH initiative. The consortium included regulatory and
political bodies (AUDA-NEPAD, PAP, the African Union Commission, the Heads of NMRAs,
the Joint United Nations Programme on HIV/AIDS), the World Bank, technical partners
(WHO, the Swiss Agency for Therapeutic Products [Swissmedic]), and donors (the Bill &
Melinda Gates Foundation, the Clinton Health Access Initiative, the UK Department for
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International Development) [12]. Another meeting, hosted by AUDA-NEPAD and WHO, fol-
lowed that November. There, the consortium began to finalize the details of its plan with input
from other stakeholders, such as the Global Fund to Fight AIDS, Tuberculosis, and Malaria;
the European Medicines Agency; and the International Federation of Pharmaceutical Manu-
facturers & Associations.
Though its immediate focus was on registering generic medicines, the consortium’s ulti-
mate vision was to coordinate the entire landscape of medicines regulation, from clinical trials
oversight to medicines registration to pharmacovigilance, across the continent. To pursue this
vision, the consortium decided to work through Africa’s RECs [12]—groups of countries that
work together through treaties to promote economic integration, including the free movement
of goods. At this time, there was only sufficient funding for the consortium to support one
pilot project. Therefore, the consortium decided to solicit proposals from each of the RECs
and fund the most promising plan for MRH over the next 5 years. Together, WHO and
AUDA-NEPAD established requirements for the proposals, as well as evaluation criteria.
These criteria included how meaningful the proposed activities would be, in terms of regula-
tory harmonization; how well the objectives were described; and how much a given REC had
already demonstrated that its partner states could cooperate to achieve common goals.
In 2012, the EAC, which at that time accounted for 14% of Africa’s population (and did not
yet include South Sudan), was chosen as the REC that would pilot the initiative [11,13]. Unlike
some RECs, the EAC consists of a small number of partner states, most of which share a com-
mon history, language, culture, and infrastructure, facilitating cooperation [7]. At the time of
application, a customs union and common market were already in force in the EAC, monetary
union was planned for 2024, and there were even future plans for a political federation in
which the EAC would become a “super state” [14]. In addition, Chapter 21, Article 118 of the
Treaty for the Establishment of the EAC, signed in 1999, provided a political platform for
MRH across the region. It called for partner states to “harmonise drug registration procedures
so as to achieve good control of pharmaceutical standards without impeding or obstructing
the movement of pharmaceutical products within the Community,” as well as “develop a com-
mon drug policy which would include establishing quality control capacities and good pro-
curement practices.” Finally, NMRA staff from Kenya, Tanzania, and Uganda had already
been working closely with each other and with WHO staff during a pilot project in which med-
icines registration applications to NMRAs and WHO’s Prequalification Programme were
assessed jointly [12].
Fig 1. Timeline of major events leading to the creation of the EAC’s MRH initiative, a pilot project for the broader AMRH initiative. AMRH, African
Medicines Regulatory Harmonization; EAC, East African Community; MRH, Medicines Regulatory Harmonization.
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Despite these advantages, the EAC faced a substantial challenge in building a regional regu-
latory system in one of the fastest growing regions in Africa. In 5 short years, this system
would have to work for nearly 150 million people, spread across roughly 2 million square kilo-
meters [7,15]. In addition, the system would have to contend with the fact that all partner states
except for Kenya were low-income countries, as classified by the World Bank [7]. Partner
states’ health systems were grappling with major problems: life expectancy across the region
was below the global average, and the infant mortality rate was above the African average
[11,13].
The partner states of the EAC were highly motivated to make the initiative a success. As
early as 2000, the EAC Integrated Council of Ministers had asked a Research, Policy, and
Health Systems Working Group to draft a common medicines policy, as well as harmonized
medicines regulatory procedures [7]. In addition, in 2005, the NMRAs of Uganda, Tanzania,
and Kenya had created a work plan for a region-wide MRH initiative. Unfortunately, their
ability to implement the plan at that time was stymied by a lack of resources. Nevertheless,
they continued to lay the groundwork for regulatory harmonization, and in 2010, AUDA-NE-
PAD engaged consultants to conduct an in-depth evaluation of the regulatory capacity and
scope of activities being conducted by each partner state [7]. This prior planning made devel-
oping an MRH proposal straightforward, and the EAC partner states were eager to use the ini-
tial US$5.5 million award from the AMRH program to turn their long-held dream into a
reality. The EAC MRH initiative was officially launched in March 2012 in Arusha, Tanzania
[12].
The goals of the EAC’s MRH initiative
Ultimately, through region-wide cooperation, the EAC hoped to increase the number of qual-
ity medicines 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. This represented a challenge. Although
most EAC partner states allowed medicines manufacturers to submit abridged dossiers for
agents that had already been approved by a recognized regulatory authority, such as the US
FDA or the European Medicines Agency, local approval processes still took an average of 24
months [7]. The reasons for these long regulatory timelines, which have been well described
by Ahonkhai and colleagues [5], included redundant steps in the technical reviews, ineffiencies
in the regulatory processes themselves, and manufacturers not meeting quality standards.
Moreover, wide variation within and between partner states existed in the length of time taken
to process applications (Fig 2), and there was often little transparency in the application pro-
cess or clarity about processing timelines. Finally, there was little communication between
EAC partner states about regulatory decisions.
To meet its overarching goal of improving access to quality medicines, the EAC MRH ini-
tiative decided to focus on
Developing and implementing
A Common Technical Document that manufacturers could use to register medicines
within any EAC partner state
A common information management system for medicines registration that would link all
partner states, as well as the EAC Secretariat
A quality management system in each NMRA, to ensure that each partner state carried out
regulatory activities in a uniform and rigorous manner
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Building the EAC’s regional and national capacity to implement registration processes and
harmonize and align technical standards
Developing and implementing a framework for partner states to eventually recognize the
regulatory findings and decisions of their neighbors
The initiative decided that an early focus would be adapting the Common Technical Docu-
ment format and guidelines created by the International Council for Harmonisation of Tech-
nical Requirements for Pharmaceuticals for Human Use, as well as resources from sources
such as the WHO Medicines Prequalification Programme and the European Medicines
Agency, for use in the EAC setting.
At the time the pilot grant was awarded, the regulatory infrastructure of the EAC’s partner
states varied dramatically [15]. Whereas Kenya, mainland Tanzania, and Uganda had well-
established NMRAs, Burundi, Rwanda, and Zanzibar had not yet established NMRAs [7].
(Zanzibar is a semi-autonomous region of the United Republic of Tanzania whose government
is responsible for its own health affairs; therefore, it has its own NMRA. As shorthand, in this
collection we refer to mainland Tanzania’s NMRA as Tanzania’s NMRA.) Furthermore [7],
Fig 2. Time to approve marketing authorization applications in the EAC prior to the EAC MRH initiative. When the
EAC’s MRH initiative began, there was substantial inter- and intra-agency variation in the length of time that NMRAs took
to approve marketing authorization applications submitted by global pharmaceutical companies. (A) Median, minimum,
and maximum times from the submission of a registration application until its approval by the NMRAs of Kenya, Tanzania,
and Uganda. For comparison, times for the US FDA and WHO are shown as well. Data were provided by 10 global
pharmaceutical companies to the Boston Consulting Group with the understanding that company and drug names would
remain confidential and spanned medicines and vaccine submissions from 1985 to 2012. (B) Even for the same medicine,
the time from submission to approval could vary dramatically between NMRAs. Here the time from submission to approval
of a single antiretroviral medicine initially submitted to the FDA during the 1985 to 2012 time period is shown for the
NMRAs of Kenya, Tanzania, and Uganda, as well as the FDA and EMA for comparison. Source information for Figure from:
Ahonkhai et al 2016 [5]. EAC, East African Community; EMA, European Medicines Agency; FDA, Food and Drug
Administration; MRH, Medicines Regulatory Harmonization; NMRA, national medicines regulatory authority; WHO,
World Health Organization.
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Each partner state that registered medicines was using a different format for its registration
applications.
Only the NMRAs of Kenya, Tanzania, and Uganda had guidelines for registering medicines
in place.
Only Kenya, Tanzania, and Uganda had the ability to assess new products (versus generics
or products that had already been approved by a recognized regulatory authority).
Only Kenya, Tanzania, and Uganda had national guidelines that met WHO standards for
good manufacturing practice (GMP).
In terms of quality management, only Tanzania’s NMRA had achieved International Orga-
nization for Standardization (ISO) 9001:2008 certification. This certification is the measure
of an agency’s quality management system as judged by ISO standards. Meeting the require-
ments for ISO certification is a globally recognized accreditation of the maturity and func-
tionality of the quality management system of an organization, including a medical products
regulatory agency.
Only Kenya, Tanzania, and Uganda had fully functioning electronic information systems
that could be used to share data and track the progress of applications.
EAC NMRAs were severely understaffed (Table 1). For example, Kenya and Uganda each
had 11 qualified staff evaluators; Rwanda and Zanzibar each had only 2.
As a result of these differences, the initiative had to incorporate a substantial amount of
capacity building so that partner states would be able to trust their neighbors to process appli-
cations according to a shared standard and to produce quality data and documents [5,16,17].
The structure of the EAC’s MRH initiative
The EAC designed its initiative’s structure with these goals in mind, also taking into account
the existing framework of the EAC. Many existing regional bodies rely on a central authority
to conduct regulatory functions, as well as a legal framework that binds partner states to the
decisions of that central authority. It was not feasible for the EAC to create such a central
authority during the 5 years of its pilot grant; rather, the goal was to implement a regional reg-
ulatory system that functioned well and could be established quickly. For that reason, the EAC
pioneered a new, decentralized regulatory system in which different partner states took pri-
mary responsibility for different regulatory functions. This approach facilitated specialization
while ensuring that all countries were fully engaged in the initiative. Although partner states
harmonized technical requirements and performed joint assessments and inspections, final
Table 1. Comparison of regulatory agency total staff numbers, as of 2013
a
.
Burundi Rwanda Kenya Tanzania Uganda UK US
Population (in millions) 10 12 44 49 38 68 335
Agency staff size 26 11 200 270 149 900 ~10,000
Staff per million residents 2.6 0.92 4.6 5.5 3.9 13.2 29.9
Region average: 3.5 staff per 1,000,000 residents
a
These data were collected at the start of the EAC’s MRH initiative in 2012–2013. Source:Bill & Melinda Gates Foundation.
Abbreviations: EAC, East African Community; MRH, Medicines Regulatory Harmonization
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decisions regarding product authorization would continue to reside at the national level;
work-sharing and reliance on the regulatory products of partner agencies would be driven by
trust and goodwill, due to existing legal requirements. Partner states would also now imple-
ment regional regulatory activities, such as joint product assessments and joint GMP inspec-
tions, alongside their existing national regulatory processes.
The EAC MRH program relied on a Steering Committee, technical working groups, and a
Project Coordination team to help carry out its functions (Fig 3). The Steering Committee
consisted of the Heads of each partner state’s NMRA, the chief pharmacists of each partner
state, the EAC Secretariat, and AMRH partners. This committee met twice a year to approve
work plans and budgets, as well as review and endorse guidelines. The initiative also capital-
ized on a model already being used successfully by the EAC: the technical working group. On
the basis of each NMRA’s strengths, the initiative assigned leadership roles:
Tanzania, which possessed the most developed semiautonomous NMRA [15], would lead
the Medicines Evaluation and Registration Working Group.
Uganda would lead the GMP Inspections Working Group.
Rwanda would lead the Information Management Systems Working Group.
Kenya would lead the Quality Management Systems Working Group.
These working groups, which typically included 2 representatives from each partner state,
as well as staff from the EAC Secretariat, AUDA-NEPAD, WHO, and development partners,
met at least twice a year to draft technical guidelines and procedures, which were presented to
the Steering Committee for review and endorsement. Finally, a Project Coordination team—
which consisted of a project coordinator; a health and informatics officer; an accountant; a
pharmaceutical program assistant; and 6 focal staff, one located in each NMRA—was
Fig 3. Governance structure of the EAC’s MRH initiative. AUDA-NEPAD, African Union Development Agency–New Partnership for Africa’s Development;
EAC, East African Community; MRH, Medicines Regulatory Harmonization; NMRA, national medicines regulatory authority; Swissmedic, Swiss Agency for
Therapeutic Products; WHO, World Health Organization.
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responsible for overall project planning, preparation, procurement, execution, monitoring,
evaluation, fund management, and reporting.
The initiative also assigned important roles to external partners (Fig 4). The World Bank,
for example, oversaw the initiative’s finances, administering funds from the AMRH multi-
donor trust fund. The World Bank disbursed funds to the EAC Secretariat, which itself man-
aged project funds for the EAC. WHO and Swissmedic both committed to providing technical
support to the EAC Secretariat and partner states’ NMRAs, as well as training in how to meet
current international standards for quality assessment and GMP inspections. Finally, AUDA--
NEPAD helped coordinate the various stakeholders involved in the initiative.
To help build the capacity of partner states with less mature regulatory systems, the initia-
tive designed a twinning system. Newly established regulatory systems were paired with more
established NMRAs (Zanzibar’s NMRA was paired with Kenya’s, Burundi’s with Tanzania’s,
and Rwanda’s with Uganda’s). By working together on joint activities, such as product assess-
ments and GMP inspections, more mature NMRAs had the opportunity to pass along best
practices, expertise, and institutional knowledge. In addition, this approach allowed the
twinned NMRAs to build relationships and confidence so that staff felt comfortable communi-
cating with one another outside of the joint activities. Relationships were also strengthened
through staff exchanges; for example, staff from Rwanda’s NMRA would spend time in Ugan-
da’s NMRA, and vice versa. These exchanges allowed NMRAs to learn from the operations
and standard operating procedures of other NMRAs, including those with greater experience
and expertise.
Conclusion
Throughout the planning process for its MRH initiative, the EAC’s primary focus was facilitat-
ing access to quality medicines through harmonization of technical requirements, regulatory
process optimization, and regional cooperation. The EAC was well aware of the initiative’s
potential benefits for its own residents. However, it was also aware that the pilot’s results
Fig 4. Role of partners in the EAC’s MRH initiative. AUDA-NEPAD, African Union Development Agency–New Partnership for Africa’s Development; BMGF, Bill &
Melinda Gates Foundation; DFID, UK Department for International Development; EAC, East African Community; MRH, Medicines Regulatory Harmonization;
Swissmedic, Swiss Agency for Therapeutic Products; WHO, World Health Organization.
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would be used to determine whether it was feasible for other African RECs to begin their own
harmonization and optimization initiatives—and, ultimately, whether it made sense to pursue
an initiative that would span the entire continent [11]. The EAC MRH initiative was innova-
tive 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.
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
(GPP3) guidelines. They also thank the Boston Consulting Group, for its help with gathering
and analyzing data.
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... One of the benefits of regulatory harmonisation is that it facilitates ongoing capacity building by having assessors engage in peer learning and receiving feedback [9]. This is evident in Africa where regional medicines regulatory harmonisation (MRH) initiatives started with the EAC, which consists of Burundi, Kenya, Rwanda, South Sudan, Tanzania, and Uganda [9,10,45,46]. The EAC MRH initiative was officially launched on 30 March 2012 in Arusha, Tanzania with the goal of improving its citizen's access to quality-assured, safe and efficacious essential medical products for the treatment of conditions that have public health importance [4,9,10,13,15,[45][46][47]. ...
... This is evident in Africa where regional medicines regulatory harmonisation (MRH) initiatives started with the EAC, which consists of Burundi, Kenya, Rwanda, South Sudan, Tanzania, and Uganda [9,10,45,46]. The EAC MRH initiative was officially launched on 30 March 2012 in Arusha, Tanzania with the goal of improving its citizen's access to quality-assured, safe and efficacious essential medical products for the treatment of conditions that have public health importance [4,9,10,13,15,[45][46][47]. When the EAC MRH project started, it relied on a Steering Committee, Technical Working Groups (TWGs), and a Project Coordination team to assist it perform its functions [46]. ...
... The EAC MRH initiative was officially launched on 30 March 2012 in Arusha, Tanzania with the goal of improving its citizen's access to quality-assured, safe and efficacious essential medical products for the treatment of conditions that have public health importance [4,9,10,13,15,[45][46][47]. When the EAC MRH project started, it relied on a Steering Committee, Technical Working Groups (TWGs), and a Project Coordination team to assist it perform its functions [46]. The Steering Committee was composed of Heads of EAC NRAs, chief pharmacists, the EAC Secretariat, and AMRH initiative partners [46]. ...
Article
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.
... Study participants were distributed into three categories; Generics (foreign); that is, applicants who manufacture generic medicines outside of the EAC region, Generics (local); that is, applicants who manufacture generic medicines within the EAC region, and Innovators; that is, applicants who submitted applications for registration of innovator medicines. During the period of study (2015)(2016)(2017)(2018)(2019)(2020)(2021), there were no local innovators that submitted applications for innovator medicines for registration. ...
... Adherence to the EAC-MRH process by the NMRAs should be promoted. Arik and others also recommended a cooperation framework agreement between NMRAs and the EAC (2020). Instituting a legally binding framework would enhance implementation of joint decisions (Giaquinto et al., 2020) and one of the study participants further suggested the elimination of national assessments of dossiers. ...
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Article
Background: A 2021 study to determine the viewpoints among the seven member countries regarding the effectiveness (i.e., achieving the intended outcomes) and efficiency (i.e., achieving the intended outcomes in timely manner with the resources available) of the East African Community Medicine Regulatory Harmonisation (EAC-MRH) Joint Assessment Procedure recommended the conduct of a similar study among pharmaceutical company applicants. The aim of this study then was to evaluate the effectiveness and efficiency of the current EAC-MRH operating model from the applicants’ perspective, including the challenges and opportunities for improvement. Methods: Using the Process Effectiveness and Efficiency Rating for Industry questionnaire developed by the authors, data were collected from company representatives responsible for EAC joint procedure submissions. Results: Responses from 14 study participants underlined the support of pharmaceutical companies for the EAC-MRH initiative, which has facilitated the harmonisation of registration requirements across the EAC region leading to one registration for all countries and a reduction of the workload for both applicants and assessors. In addition, it is expected that shorter timelines for approval will lead to improved access to quality-assured essential medicines in the region. Access to various markets at the same time was also noted as an important benefit to pharmaceutical companies. Noted challenges include a lack of process information, a lack of centralised submission and tracking process and a lack of mandated central registration. A key strategy proposed by participants is the establishment of a regional administrative body to centrally receive and track EAC applications and the eventual establishment of a Regional EAC Medicines Authority. Conclusion: This is the first study evaluating the performance of the EAC work-sharing initiative from the point of view of the applicants. In general, the applicants believe that the system performs efficiently and fulfils its promise. However, some participants indicated that in some countries an EAC positive recommendation does not directly result in an individual country approvals. Following the recommendations listed in this report may mitigate identified areas for improvement and facilitate the overall goal of the EAC-MRH initiative to expedite the availability of needed quality-assured medicines to patients in the region.
... Given the capacity differences in regulating medical products in African Member States, it is important to note that the African Union (AU) Member States and Regional Economic Communities (RECs) are making significant efforts to improve access to safe, quality, and efficacious medical products through strengthening and harmonising medicines regulatory systems. Studies show that the reluctance from companies manufacturing medical products to register their products in African markets is one of the major factors delaying access to medicines (Sillo et al., 2020). Reasons for this reluctance is due to the lengthy application process, the time, expense, and effort needed for this registration process in each NRA (Sillo et al., 2020). ...
... Studies show that the reluctance from companies manufacturing medical products to register their products in African markets is one of the major factors delaying access to medicines (Sillo et al., 2020). Reasons for this reluctance is due to the lengthy application process, the time, expense, and effort needed for this registration process in each NRA (Sillo et al., 2020). To improve access to safe, quality and effective medical products, the EAC joint assessment project was established in 2012, to assist in facilitating the market authorisation application process for manufacturers through a faster review of applications in the region. ...
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Article
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.
... Every country should ensure an adequate supply of safe, efficacious, good quality, and affordable medical products to promote public health [3].Effective regulatory systems ensure that the medical products meet the recommended standards to protect and promote public health [4,5]. All countries globally are encouraged to have functional, effective, and efficient National Regulatory Authorities (NRAs) [6]. However, at least 30% of the existing NRAs have constrained capacity to perform core regulatory functions [7,8]. ...
... Our study focused on the regulation of unregistered medicines, an area often neglected and not fully addressed in ongoing efforts to strengthen regulatory systems. Nonetheless, the results are consistent with previous reports; for example, the estimates that only 30% of NRAs among SADC Member States can effectively and efficiently regulate medical products in their countries [36].The results are also consistent with other studies that observed that legal frameworks lacked or were fragmented in most African countries [2,6] Additionally, some studies have shown that implementing medicines control regulation on the importation, use, and reporting of adverse drug reactions in developing countries is by far still too low compared to the levels in high-income countries [37,38]. This may result in NRAs in SADC, or similar settings, allowing the importation of medicines whose quality is unknown and not being adequately assessed. ...
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Article
Background The purpose of the study was to assess the requirements for approval of the importation of unregistered medicines for use in the public sector in the Southern African Development Community (SADC) countries. Methods The study reviewed the legal provisions and requirements to be fulfilled when importing unregistered medicines for the public sector in SADC countries relative to two comparators drawn from countries with stringent regulatory systems through extant document analysis. The relative implementation index score was calculated and used to measure the level of implementing legal provisions and requirements to be fulfilled. Analysis was performed using the STATA software package. Results Approximately 13 out of 16 SADC countries had a relative implementation index below 50%. The aggregated implementation index across all SADC countries was 44%, ranging from 4 to 54%, while the two comparators had a relative implementation index of 81% and 85%, respectively. Conclusion Implementing the minimum requirements for importing unregistered medicines for the public sector was deficient compared to the jurisdictions with stringent regulatory systems, and wide implementation gaps also existed within the SADC region.
... Challenges ahead include shifting from donor support to becoming self-sustained, optimizing the cooperation between NRAs with very different levels of resources and experience, and moving toward a more transparent system that is easier to navigate. 23 Regulatory harmonization is growing in the African context, characterized hitherto by variable regulatory capacities 24 and a high prevalence of SF medicines (estimated at 19%, while 42% of the reports of SF products submitted to WHO between 2013 and 2017 come from this region). 7 In 2009, the African Medicines Regulatory Harmonization initiative was launched to create more effective, efficient, and transparent regulatory mechanisms across the continent. ...
Article
In this paper, we argue that understanding and addressing the problem of poor-quality medical products requires a more interdisciplinary approach than has been evident to date. While prospective studies based on rigorous standardized methodologies are the gold standard for measuring the prevalence of poor-quality medical products and understanding their distribution nationally and internationally, they should be complemented by social science research to unpack the complex set of social, economic, and governance factors that underlie these patterns. In the following sections, we discuss specific examples of prospective quality surveys and of social science studies, highlighting the value of cross-sector partnerships in driving high-quality, policy-relevant research in this area.
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Objective: To investigate the availability of and access to opioid analgesics at hospital level in the Democratic Republic of Congo. Methods: Exploratory mixed-method study combining a descriptive survey of the availability of opioid analgesics at hospital pharmacies with a qualitative survey that explored the experiences and perceptions of health care workers, managers, patients and caregivers, by means of a short questionnaire and of semi-structured interviews. The study was conducted in a convenience sample of twelve hospitals, located in five different provinces, in 2021. Results: The quality and completeness of stock data for opioid analgesics were generally poor. Stock-outs were frequent. Only five hospital pharmacies had records on prescriptions of opioids in 2020. In-patients and caregivers indicated they generally must purchase opioids out-of-pocket, sometimes far from the place of residence. Doctors and nurses confirmed that prescribed opioids are often unavailable at the hospital pharmacy. Furthermore, they suggested an important need of training in pain management with opioids, and of effective regulation to ensure opioid availability. Pharmacists and managers recognized important weaknesses in the processes of needs quantification, stock management, planning and supply. Conclusions: Our exploratory study suggests the need of a complex set of coordinated actions to be undertaken by all relevant actors in DRC to correct the poor practices in opioid management and to improve opioid availability, affordability and adequate use. This will require a change of mindset to overcome the neglect of the health needs of persons with acute and chronic pain.
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Preprint
Background The purpose of the study was to assess the requirements for approval of the importation of unregistered medicines for use in the public sector in the Southern African Development Community (SADC) countries. Methods The study reviewed the legal provisions and requirements to be fulfilled when importing unregistered medicines for the public sector in SADC countries relative to two comparators drawn from countries with stringent regulatory systems through extant document analysis. The relative implementation index score was calculated and used to measure the level of implementing legal provisions and requirements to be fulfilled. Analysis was performed using the STATA software package. Results Approximately 13 out of 16 SADC countries had a relative implementation index below 50%. The aggregated implementation index across all SADC countries was 44%, ranging from 4% to 54%, while the two comparators had a relative implementation index of 81% and 85%, respectively. Conclusion Implementing the minimum requirements for importing unregistered medicines for the public sector was deficient compared to the jurisdictions with stringent regulatory systems, and wide implementation gaps also existed within the SADC region.
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Article
Congenital adrenal hyperplasia (CAH), if untreated, carries high morbidity and mortality. A higher incidence of CAH is expected in countries where consanguinity is common, such as in the countries of the WHO Eastern Mediterranean Region (EMRO). CAH is managed through lifelong treatment with fludrocortisone and hydrocortisone. In this analysis, performed in the 22 EMRO countries and territories plus Algeria, we review which countries offer a neonatal screening programme for CAH and describe the barriers and opportunities to access oral fludrocortisone and oral and injectable hydrocortisone. Neonatal CAH screening was only available nationally in Qatar, Kuwait and partially in Lebanon and Saudi Arabia. We reviewed the national lists of essential medicines (NEMLs) and found that 13/23 (57%) countries included fludrocortisone and 18/23 (78%) included oral hydrocortisone. Fludrocortisone was not included by any of the low-income countries and oral hydrocortisone was only included by one low-income country. We then contacted paediatric endocrinologists in each country to assess perceived availability of these medicines. Overall, there was a relatively good consistency between inclusion of fludrocortisone and hydrocortisone in the NEML and their actual availability in a country. We propose several mechanisms to improve access, including prequalification by the WHO, a common registration process for groups of countries, pooled procurement, working with local pharmaceutical companies, special access status for medicines not yet registered in a country and compounding. We suggest that access to medicines requires a collaboration between health professionals, families of patients, health authorities, pharmaceutical companies and the WHO.
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Technical Report
Local manufacturing for health in Africa in the time of Covid-19: experience and lessons for policy.
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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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Article
Background The United Nations Millennium Development Goals galvanized global efforts to alleviate suffering of the world’s poorest people through unprecedented public-private partnerships. Donor aid agencies have demonstrably saved millions of lives that might otherwise have been lost to disease through increased access to quality-assured vaccines and medicines. Yet, the introduction of these health interventions in low- and middle-income countries (LMICs) continues to face a time lag due to factors which remain poorly understood. Methods and Findings A recurring theme from our partnership engagements was that an optimized regulatory process would contribute to improved access to quality health products. Therefore, we investigated the current system for medicine and vaccine registration in LMICs as part of our comprehensive regulatory strategy. Here, we report a fact base of the registration timelines for vaccines and drugs used to treat certain communicable diseases in LMICs. We worked with a broad set of stakeholders, including the World Health Organization’s prequalification team, national regulatory authorities, manufacturers, procurers, and other experts, and collected data on the timelines between first submission and last approval of applications for product registration sub-Saharan Africa. We focused on countries with the highest burden of communicable disease and the greatest need for the products studied. The data showed a typical lag of 4 to 7 years between the first regulatory submission which was usually to a regulatory agency in a high-income country, and the final approval in Sub-Saharan Africa. Two of the three typical registration steps which products undergo before delivery in the countries involve lengthy timelines. Failure to leverage or rely on the findings from reviews already performed by competent regulatory authorities, disparate requirements for product approval by the countries, and lengthy timelines by manufacturers to respond to regulatory queries were key underlying factors for the delays. Conclusions We propose a series of measures which we developed in close collaboration with key stakeholders that could be taken to reduce registration time and to make safe, effective medicines more quickly available in countries where they are most needed. Many of these recommendations are being implemented by the responsible stakeholders, including the WHO prequalification team and the national regulatory authorities in Sub-Saharan Africa. Those efforts will be the focus of subsequent publications by the pertinent groups.
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Article
Access to medicines has long been and remains a challenge in African countries. The impact of medicines registration policies in these countries poses a challenge for pharmaceutical companies wanting to register medicines in these countries. The recent AMRHI (African Medicines Registration Harmonisation Initiative) has increased the focus on the need for harmonisation. Medicines registration regulations differ across African countries. Anecdotal evidence, based on the experience of pharmaceutical companies on progress towards harmonisation is somewhat different, i.e. that country specific requirements were a barrier to the registration of medicines. The objective of this study was therefore to determine the nature and extent of regulatory hurdles experienced by pharmaceutical companies who wish to register and supply medicines to African countries. This cross-sectional descriptive pilot study was conducted across pharmaceutical companies, both local and multinational. These companies were based in South Africa and were also members of Pharmaceutical Industry Association of South Africa (PIASA). The pharmaceutical companies supply both the private and public sectors. An online survey was developed using Survey Monkey. Survey questions focused on the following strands: nature and level of current supply of medicines to African countries by companies, general regulatory requirements, region specific questions and country specific questions across four regional economic communities in Africa, namely; Southern African Development Community (SADC), East African Community (EAC), Economic Community of the West African States (ECOWAS) and Economic Community of Central African States (ECCAS). A total of 33 responses were received to the questionnaire of which 26 respondents were from the PIASA Regulatory working group and 7 were from the PIASA Export working group.It was noted that since most of the regulatory authorities in Africa are resource-constrained, harmonisation of medicine registration policies will contribute positively to ensuring the safety, quality and efficacy of medicines. The experience of pharmaceutical companies indicated that country specific regulatory requirements are a barrier to registering and supplying medicines to African countries. In particular, GMP inspections, GMP inspection fees and country specific labeling were cited as key problems. Pharmaceutical companies operating in African markets are experiencing difficulties in complying with the technical requirements of individual African countries. Further research is required to provide a balanced perspective on the country specific regulatory requirements vs. the African Regulatory Harmonisation Initiative (AMRHI).
Chapter
This chapter outlines the example of a regional effort to improve access to medicines through regulatory harmonization in the East African Community. The East African Community (EAC) consists of five Partner States: Burundi, Kenya, Uganda, Rwanda, and Tanzania. The Republic of Southern Sudan was recently admitted to the EAC as the sixth Partner State on March 2, 2016. The East African Community Medicines and Health Technologies Policy is under development to complement provisions of EAC Treaty, Article 118, Chapter 21 on regional cooperation on health and EAC Common Market Protocol in which integration in the health sector is the main policy priority. An assessment of medicines’ policies and pharmaceutical legislation was undertaken in all five EAC Partner States in May–June 2015. Key findings indicated that all Partner States have medicine policies, and three Partner States with updated medicine policies. Constitutional changes are driving the policy reform with human rights principles underpinning policies. Implementation planning, together with monitoring and evaluation, are areas requiring support across the EAC. The recommendation for the regional pharmaceutical policy is to guide action in three areas, namely, access, quality, and rational use. The scope of the regional policy needs to include pharmaceuticals for human and veterinary use plus medical devices, health technologies, food, and cosmetics. All Partner States have pharmaceutical legislation in place; however, this is outdated and is in need of reform to align to the regional harmonization initiatives and allow countries to implement their policies in a timely and efficient manner. The slow pace of legislative reform is a barrier to improve access to essential medicines and health commodities across the region. In terms of the medicines’ regulatory harmonization agenda, legal frameworks for mutual recognition and information sharing are key. Considering the different stages of development across the EAC Partner States and the enablers, together with regional goals and aspirations, a phased approach to implementation of the regional policy and legislation is recommended. First, adopt a stepwise approach to regional collaboration in the pharmaceutical sector starting with implementation of national policies. Second is to establish the East African Community Medicines and Food Safety Commission. Alongside these developments, information sharing activities should increase and continue.
first novel antiviral agent in six years, approved by FDA. Treatment Action Group website
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Tenofovir (Viread), first novel antiviral agent in six years, approved by FDA. Treatment Action Group website. 2001 [cited 2019 March 25]. Available from: http://www.treatmentactiongroup.org/tagline/ 2001/november/tenofovir-viread-first-novel-antiviral-agent-six-years-approved-fda.
A Continent of Opportunities for Pharma and Patients
  • T Holt
  • M Lahrichi
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  • Africa
Holt T, Lahrichi M, Santos da Silva J. Africa: A Continent of Opportunities for Pharma and Patients. McKinsey & Company, 2015.
WHO support for medicines regulatory harmonization in Africa
WHO support for medicines regulatory harmonization in Africa: Focus on East African Community. WHO Drug Inform. 2014; 28(1):11-5.