Recommended Citation
Mashingia, Jane; Maboko, S; Mbwiri, P I.; Okello, A; Ahmada, S I.; Barayandema, R; Tulba, R; Byomuhangi, E; Ekeocha, Z; Byrn, S; and Clase, K, "Joint Medicines Regulatory Procedure in the East African Community: Registration Timelines and Way Forward" (2021). BIRS Africa Technical Report Papers. Paper 3.
http://dx.doi.org/10.5703/1288284317429
DOI
10.5703/1288284317429
Tech Report Number
TR-BIRSAFRICA-2021-3
Date of this Version
11-1-2021
Keywords
Registration, assessment, timelines, harmonization, regulatory review, medicinal Products, marketing authorization
Abstract
A review of the East African Community (EAC) joint regulatory review process was conducted, registration timelines analyzed and key milestones, challenges and opportunities documented for the period of July 2015 to January 2020. A total of 113 applications were submitted for joint scientific review. Among these, 109 applications were assessed, 57 were recommended for marketing authorisation, 52 applications had queries to applicants and four applications were under review. A total median approval time for all products ranged from 53 to 102 days. The maximum time taken by a regulator to review the dossier was 391 days and the minimum time was 44 days. For applicants, the maximum time to respond to queries was 927 days and the minimum time was nine days. The total median time for granting marketing authorisation by the National Medicines Regulatory Authorities (NMRA) decreased from 174 to 39 working days in 2015 and 2019 respectively. However, not all EAC NMRA has granted marketing authorisation to all 57 products due to non-payment of applicable fees by applicants. Long regulatory approval timelines were contributed by limited capacity for timely scientific review of dossier by some NMRA, lack of online portal to share dossiersand assessment reports, delay in responding to queries by applicants and deficiencies in dossier. The metric tool and register of medical products submitted for joint scientific review had incomplete data. Challenges were identified and actions recommended to ensure regional regulatory system optimization, efficiency, transparency, sustainability and accountability.