East African Community Registers Five Drugs in Pilot Program

The East African Community Medicines Regulatory Harmonization (EAC-MRH) program reached a major milestone this year with the successful registration of five critical health products. The medicines—three antimalarial and two reproductive health products—were reviewed in a joint effort by all five EAC member states: Burundi, Kenya, Rwanda, Tanzania and Uganda. This effort, a pilot project launched in July 2013 with support from the World Health Organization (WHO), marked the first time the EAC nations have conducted collaborative reviews of health products for national registration. To learn more about the EAC-MRH, read the July 2012 Regulatory Focus article, East Africa Leads Medicine Registration Harmonization Thrust.

The EAC-MRH is at the forefront of the African Medicines Regulatory Harmonization (AMRH) program, an initiative of the New Partnership for Africa’s Development (NEPAD). The goal of the AMRH program is to improve public health and access to medicines by “harmonizing medicines regulations, and expediting registration of essential medicines.”¹ AMRH efforts include harmonizing regional regulatory systems, bolstering regulatory capacity and pooling resources within existing regional economic communities (RECs). The program is supported by its partner consortium, which includes the African Development Bank, African Union Commission, Bill & Melinda Gates Foundation, Clinton Health Access Initiative, Pan-African Parliament, World Bank, UK Department for International Development, UNAIDS and WHO.

Reduced Registration Times

Based on previous registration data, the amount of time required for a generic medicine to be registered in EAC member states is often close to two years. Through collaboration, the EAC member states were able to register these products in March 2014, less than one year after the pilot project’s launch. The significant reduction in registration time is due in part to the use of the WHO Prequalification Programme, created to work with national regulatory authorities and manufacturers to assess generic and brand-name medicines for safety and efficacy in treating HIV/AIDS, malaria and tuberculosis. More recently, the WHO Prequalification Programme added products used for reproductive health as an area of focus.

The registered drugs, all generics, include three antimalarial medications, artesunate 25 mg + amodiaquine 67.5 mg, artesunate 100 mg + amodiaquine 270 mg, and artesunate 50 mg + amodiaquine 135 mg (using the trade name Falcimon) and two reproductive health products (using the trade names Misoprost 200 and Pill 72). In addition to registering products more quickly, the joint review by EAC member states is ensuring wider access to the medicines in the region.

Barriers to Access and Trade

In a July 2012 article in the Southern Med Review,² researchers surveyed companies, both local and multinational, to determine the perceived barriers to medicines registration in different African RECs. Respondents identified the lack of recognition of international standards, Good Manufacturing Practice (GMP) inspections and inspection fees and country-specific labeling requirements as significant barriers across multiple RECs. The companies surveyed indicated these barriers contributed to the commercial decision not to supply some or all of their products in a number of countries, including Ghana, Kenya, Tanzania and Uganda.

Unique Challenges

Over the past two decades, many aspects of healthcare have improved in Africa; however, significant challenges remain, especially involving access to medicine. Between 1990 and 2011, average life expectancy for Africans rose from 50 to 56 years. While this is well below global averages, the rate of change exceeded that of the global average in that same period. In addition, Africa has seen significant improvement in mortality rates for children under five and infants, both of which dropped nearly 50% between 1990 and 2012. However, Africa’s greatest health challenges stem from the disproportionate incidence of communicable and infectious diseases, many of which are treatable. Africa is home to about one-seventh of the world’s population; however, two-thirds of people with HIV/AIDS live in Africa. Additionally, 90% of all malaria cases occur in Africa, and Africans account for more than a quarter of tuberculosis cases worldwide. According to WHO, only 51% of people with multi-drug resistant tuberculosis in the African region receive treatment.³

Why are the AMRH and EAC-MRH efforts so significant to overall health outcomes in Africa? Africans suffer from a number of tropical diseases that are not seen as commonly, or at all, in Western nations. Therefore, many medicines that target tropical diseases may not be reviewed or registered in those countries. Although in the past many African regulatory authorities relied on assessments conducted by regulatory authorities such as the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA), today they face increasing responsibility for performing regulatory reviews of new formulations and fixed-dose combination drugs. This shift can cause a significant delay in the availability of some products. With these issues in mind, policymakers in Africa have set their sights on improving their regulatory systems to be better equipped to provide timely access to new medicines.

Next Steps

In March 2014, the first regional stakeholders meeting for the EAC-MRH program was held to validate the harmonized guidelines, standards and requirements developed by the program’s four technical working groups (TWGs) before sending them to the member states for approval. The TWGs are: Medicines Evaluation and Registration, GMP, Quality Management System and Information Management System.

Following the early success of the EAC-MRH, two additional RECs, the Economic Community of West African States (ECOWAS) and the Southern African Development Community (SADC) decided to move their regulatory harmonization efforts forward with support from the World Bank. In ECOWAS, two major organizations, the West African Health Organization and the West African Economic and Monetary Union, are reaching consensus on the details of their partnership in the effort to establish a regulatory authority for the region. The heads of the various national medicines regulatory authorities from SADC met in June 2014 in Gaborone, Botswana, to validate their region’s MRH project proposal.

The launch of harmonization efforts in Western and Southern Africa represents a significant step in the continuation of the AMRH program’s goals to increase availability and access to medicines on the continent.

References

African Medicines Regulatory Harmonization. AMRH website. http://www.amrh.org/. Accessed 1 July 2014.
Narsai K, Williams A, Mantel-teeuwisse AK. Impact of regulatory requirements on medicine registration in African countries–– perceptions and experiences of pharmaceutical companies in South Africa. South Med Rev. 2012;5(1):31-7. National Center for Biotechnology Information website. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3471191/. Accessed 1 July 2014.
The World Health Organization. Atlas of African Health Statistics 2014: Health Situation Analysis of the African Region. World Health Organization website. http://www.aho.afro.who.int/sites/default/files/publications/921/AFRO-Statistical_Factsheet.pdf. Accessed 1 July 2014.

About the Author

Michael Mezher works as the policy and research coordinator at RAPS, where he follows regulatory policy and assists with RAPS research efforts. He can be reached at [email protected].

Cite as: Mezher M. “East African Community Registers Five Drugs in Pilot Program.” Regulatory Focus. July 2014. Regulatory Affairs Professionals Society.

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