Around the Globe

African Medicines Agency Treaty Ratification, Regional Regulatory Harmonization, and Joint Assessments Actively Under Way
David Mukanga
Bill and Melinda Gates Foundation

ollaborative regional legislative and agency efforts continue to drive regulatory harmonization throughout Africa in the effort to increase the safety and speed of clinical trials and ultimately the registration of safe and efficacious new medicines on African markets and the reliable availability of these medicines to the patients who need them.

Rwanda Ratifies AMA Treaty

On June 12, Rwanda became the first country to ratify the treaty for the establishment of the African Medicines Agency (AMA). A number of countries are expected to follow shortly. After 15 countries ratify this treaty, AMA will become an institution of the Africa Union, and will begin to establish its offices.

Working with the African Union Commission, the African Union Development Agency (AUDA-NEPAD), and other partners, the Boston Consulting Group (BCG) is leading the process of developing the AMA strategy and business plan. BCG is now in the consultation process with countries, regional economic communities, and other stakeholders. It is expected that the strategy and business plan will be ready by the end of 2019.

African Vaccine Regulatory Forum (AVAREF)

  • Joint review (involving Ghana, Malawi, and Zambia) of a phase 3 clinical trial for a trivalent P2-VP8 rotavirus subunit vaccine was conducted in April 2019.
  • AVAREF will facilitate the development and implementation of a roadmap for African country registration for the Merck Ebola Vaccine through a face-to-face meeting to be held July 30-31 in Kigali. Developed by the WHO, the proposed roadmap, explaining the process and steps, is available on WHO’s website.
  • In collaboration with the African Academy of Science (AAS), AVAREF developed a questionnaire/checklist that national regulatory authorities, national ethics committees, and Institutional Review Boards will use to provide information about their regulatory environment. These responses will be fed into a database on clinical site capacity and the regulatory environment under development by the AAS and to be hosted on the AVAREF website. We expect that this process will bring significant transparency to the regulatory ecosystem.

Southern Africa Development Community (SADC)

The SADC regional medicines regulatory harmonization program was launched in June 2019 in Gaborone. The ZAZIBONA procedure, which will now expand to include other SADC countries, is progressing well with 258 applications received, 181 reviews completed, and 107 recommendations for registration at national level. It takes about ten months to receive a recommendation under ZAZIBONA, and on average 100 days from regional recommendation to national registration.

East African Community (EAC)

Under the EAC joint assessment procedure, a total of 84 applications have been received, 77 evaluated, and 33 recommended for registration. It takes about nine months to receive a recommendation under the EAC procedure. The Gates Foundation and the New Partnership for Africa’s Development (NEPAD) are working with the EAC to generate timely and reliable post-recommendation timelines of this procedure at the national level.

Economic Community of West African States (ECOWAS)

The Steering Committee for the ECOWAS regional regulatory harmonization initiative will meet in July 2019 to finalize the regional joint assessment procedure. It is expected that this procedure will get underway in the fourth quarter of 2019, with a single filing offering access to the 350 million population of ECOWAS.