An Assessment of Regulatory Submissions in East & West Africa


In the February edition of DIA’s Global Forum magazine Sybil Nana Ama Ossei-Agyeman-Yeboah of the West African Health Organization, Jane H. Mashingia from the East African Community Medicines Regulatory Harmonization Programme, and the Bill & Melinda Gates Foundation’s David Mukanga examine 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.


Read the full article on the DIA Global Forum website here

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