Coming together to improve access to
medicines: The genesis of the East African
Community’s Medicines Regulatory
, Aggrey Ambali
, Samvel Azatyan
, Chimwemwe ChamdimbaID
, Joseph KabatendeID
, Murray LumpkinID
, Jane H. MashingiaID
*, Bonaventure Nyabenda
, Gordon SematikoID
, Burhani SimaiID
, Fred SiyoiID
, Stanley Sonoiya
, Mike Ward
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
• 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
• 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
• We describe the solution to this problem developed by the East African Community
(EAC) and launched in 2012: the EAC Medicines Regulatory Harmonization (MRH)
• 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
PLOS Medicine | https://doi.org/10.1371/journal.pmed.1003133 August 12, 2020 1 / 11
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.
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
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 , 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 . 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 . Even in the relatively large
market of South Africa, the manufacturer did not apply for registration until late 2005 .
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 . 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 .
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 . 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 .
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 , 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 . 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
PLOS Medicine | https://doi.org/10.1371/journal.pmed.1003133 August 12, 2020 2 / 11
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
Provenance: Not commissioned; externally peer-
in children under the age of 5 years . 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 .
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 . 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 . 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
. 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
PLOS Medicine | https://doi.org/10.1371/journal.pmed.1003133 August 12, 2020 3 / 11
International Development) . 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 —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 . 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” . 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 .
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.
PLOS Medicine | https://doi.org/10.1371/journal.pmed.1003133 August 12, 2020 4 / 11
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 . 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
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 . 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 . 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
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 . The reasons for these long regulatory timelines, which have been well described
by Ahonkhai and colleagues , 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
PLOS Medicine | https://doi.org/10.1371/journal.pmed.1003133 August 12, 2020 5 / 11
• 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 . Whereas Kenya, mainland Tanzania, and Uganda had well-
established NMRAs, Burundi, Rwanda, and Zanzibar had not yet established NMRAs .
(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 ,
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 . 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.
PLOS Medicine | https://doi.org/10.1371/journal.pmed.1003133 August 12, 2020 6 / 11
• Each partner state that registered medicines was using a different format for its registration
• Only the NMRAs of Kenya, Tanzania, and Uganda had guidelines for registering medicines
• 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
• 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
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
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
PLOS Medicine | https://doi.org/10.1371/journal.pmed.1003133 August 12, 2020 7 / 11
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 , 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.
PLOS Medicine | https://doi.org/10.1371/journal.pmed.1003133 August 12, 2020 8 / 11
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
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.
PLOS Medicine | https://doi.org/10.1371/journal.pmed.1003133 August 12, 2020 9 / 11
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 . 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” , we will describe what this innovative
approach allowed the initiative to accomplish, including its most significant achievements and
its biggest challenges.
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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