- Mots-clés > African Medicines Regulatory Harmonization (AMRH)
- Mots-clés > EAC Medicines Regulation Harmonization (MRH)
- Mots-clés > harmonization - medicines registration
- Mots-clés > harmonization of medicines regulation
- Mots-clés > marketing authorization
- Mots-clés > medicines regulation
- Mots-clés > National Medicines Regulatory Authority (NMRA)
- Mots-clés > registration - Collaborative Registration Procedure (CRP)
- Mots-clés > regulatory framework
- Mots-clés > regulatory institutional capacity
(2017; 10 pages)
Efficient and aligned regulatory systems are crucial in ensuring access to medical products of assured quality. However, marketing authorizations of needed products are often delayed as researchers and manufacturers must navigate multiple regulatory requirements to register their products across countries.
In the East African Community (EAC), efforts are under way for harmonization of technical requirements for medicines regulation. This article presents a comparison of legal and regulatory frameworks for the regulation of medicines in EAC partner states. The findings show some commonalities but also differences and gaps, underlining the need for convergence towards a common medicines regulatory framework in line with international standards.