Three compendiaums of MER, QMS, GMP Documents developed and adopted by 9th Sectoral Council of
Health on 17th April 2014, and 29th EAC Council of Ministers on 20th Sept 2014
7 NMRAS implementing the EAC Harmonized Technical Guidelines for Regulation of Medicines
10 Joint Medicines Evaluation and assessment sessions and four joint GMP Inspections conducted
27 Medical Products jointly registered through EAC-MRH Joint scheme of medicines registration
Five NMRAs of Kenya, Rwanda Tanzania Mainland, Uganda Zanzibar, and ISO Certified 9000:2008
Framework for mutual recognition of regulatory decisions developed and implemented
EAC Regional Pharmaceutical Policy, Legal and Regulatory Framework developed Gazettement of
Medicines Regulatory Agency in Rwanda in 2018 (Rwanda Food and Drug Authority)
Three Regional centers of excellences established: Medicine Registration TFDA, Good Manufacturing
Practices -NDA, Pharmacovigilance-PPB
