- Mots-clés > African Medicines Regulatory Harmonization (AMRH)
- Mots-clés > drug registration
- Mots-clés > harmonization of medicines regulation
- Mots-clés > International Conference on Harmonisation (ICH)
- Mots-clés > marketing authorization
- Mots-clés > medicines registration
- Mots-clés > National Medicines Regulatory Authority (NMRA)
- Mots-clés > registration of medicinal products
- Mots-clés > regulatory harmonization
- Mots-clés > regulatory institutional capacity
(2010; 56 pages)
This Situation Analysis Report on Medicines Registration Harmonization for the East African Community (EAC) has been prepared following rigorous scientific and participatory methods, including the administration of three separate structured questionnaires to the regional economic community (REC), pharmaceutical manufacturers and national medicines regulatory authorities (NMRAs); and a review of documents from the REC and NMRA, including reports by the World Health Organization (WHO) on medicines regulatory harmonization in Africa and discussions with key people from the REC and NMRAs.
The purpose of the situation analysis was to establish the status of medicines regulation capacity, harmonization efforts and challenges in the EAC and member states with a view to enhancing better understanding of the situation in the region, learning from past experiences and developing appropriate interventions to facilitate African Medicines Regulatory Harmonization (AMRH). The report has been prepared by the consultant with invaluable support received from the EAC Secretariat, heads of national medicines regulatory authorities and pharmaceutical manufacturers and their associations.
The report serves among other things as a baseline on the status of medicines regulatory harmonization in the region, and focuses efforts towards responding to identified gaps, while capitalizing on existing strengths.
As part of regional cooperation on health, the EAC partner states have initiated the process of harmonizing the regulation of the manufacture, import, trade, sale and export of all medicines and health supplies within the region through the legal mandate of the existing NMRAs in each of the partner states. Nonetheless, there is a need for institutionalization of the harmonization of medicines in order to secure and build on the gains that have been made thus far.
This situation analysis report and the data it provides will prove to be a very important source of data to support the efforts to institutionalize and fast-track the harmonization of medicines regulation in the EAC, which focus on the full realization of the benefits of the growing pharmaceutical industry in the region as well as ensuring easy access to affordable, safe and quality essential medicines and health supplies for both local use and export to international markets