Around the Globe

Assessment of Regulatory Submissions in East Africa and West Africa
Sybil Nana Ama Ossei-Agyeman-Yeboah
West African Health Organization
Jane H. Mashingia
East African Community Medicines Regulatory Harmonization Programme
David Mukanga
Bill & Melinda Gates Foundation
@gatesfoundation
T

he following report provides updates on the state of joint assessment procedures in the East African and West African communities.

East African Community Joint Assessments

The East African Community (EAC) regional joint assessment procedure established in 2015 received 169 applications, assessed 159, and recommended 79 applications for marketing authorization (MA) by November 30, 2021. The MA timeline was reduced from 24 months to 8-14 months through the joint assessment procedure, which aims to reduce duplication of cost and effort and promote more efficient use of resources through implementation of a common approach in assessment of safety, efficacy, and quality of medical products by pharmaceutical industries and national medicines regulatory authorities (NMRA).

The various levels of technical expertise and skills among regulators in different countries contribute to strengthening the capacity of each NMRA and expedite introduction of priority medicines for their patients. The EAC held stakeholder meetings with the Kenya Association of Pharmaceutical Industry (KAPI) in October; with the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) in November; and another in November with the Southern African Pharmaceutical Regulatory Affairs Association (SAPRAA). All these meetings sought to further socialize the EAC joint assessment procedure among potential industry applicants and encourage its uptake.

The EAC call for applications remains open and 2022 assessment dates have already been scheduled: February 7-11, April 25-29, August 8-12, and October 10-14. EAC looks forward to continuing to work on optimizing this application procedure and encourages companies to submit applications.

Economic Community of West African States (ECOWAS)

The Economic Community of West African States (ECOWAS) has been working on a policy to support its regulatory harmonization agenda. The ECOWAS Medicines Regulatory Harmonization (MRH) cooperation framework was adopted by the 22nd Ordinary Assembly of ECOWAS Health Ministers (AHM) in November 2021. By November 30, 2021, the ECOWAS joint assessment procedure had received applications for 21 products and recommended four for marketing authorization. Applications for eight of these 21 products remain on hold as applicants prepare responses to initial screening queries.

The 2022 submission windows for these ECOWAS joint assessment applications are February 1-28, May 1-31, July 1-31, and October 1-31.

Read more Global Forum Regional Reports from Africa:

Making COVID-19 Global Vaccine Distribution Safer and More Efficient

AVAREF Workshops Accelerating COVID-19 Vaccine Access in Africa

African Medicines Regulatory Harmonization: Plans to Collaborate on COVID Vaccine Emergency Use Authorization

Back to Issue