EFDA, AHRI, and USP/PQM Plus Collaborate with Local Pharmaceutical Manufacturers to Implement National Bioequivalence Roadmap
The Ethiopian Food and Drug Authority (EFDA) and the Armauer Hansen Research Institute (AHRI), in collaboration with USP/PQM Plus, held a discussion with local pharmaceutical manufacturers on implementing the National Bioequivalence Roadmap. This initiative aims to ensure the quality, safety, and efficacy of drugs in Ethiopia.
During the consultation forum, held in Addis Ababa on October 16, 2024, Seyum Wolde, Deputy Director General of EFDA’s Pharmaceutical Sector, emphasized the importance of bioequivalence research for domestic drug manufacturers. He highlighted that presenting research results for these manufacturers would facilitate granting market licenses for their products, contributing significantly to quality control efforts.
Seyum also stressed the need for EFDA to establish a standardized procedure to apply bioequivalence test results for both imported and domestically produced drugs. The Authority, having considered the recommendations from the World Health Organization (WHO), has issued various guidelines to implement bioequivalence research results for locally manufactured drugs.
The forum included presentations of action plans and implementation procedures from local manufacturers, with participants agreeing that further strengthening of these efforts is essential for the roadmap’s success.