EAC Medicines Regulatory Harmonization (MRH) Programme

EAC Medicines Regulatory Harmonization (MRH) Programme is rated 3 out of 5 in the category government administration. Read and write reviews about EAC Medicines Regulatory Harmonization (MRH) Programme. ABOUT EAC-MRH The East African Community Medicines Regulatory Harmonization (EAC-MRH) Programme was launched in 2012 with a charitable purpose of improving access to safe, efficacious and good quality essential medicines for the treatment of conditions of public health importance in the East African Community Partner States. PROGRAMME GOAL To have a harmonized and functioning medicines registration and regulation system within the East African Community in accordance with the national and internationally recognized standards and best practices PROGRAMME OBJECTIVES - To implement a common technical document for registration of medicines - To implement a common information management system (IMS) for medicines registration - To implement a quality management system in each EAC Partner States National Medicines Regulatory Authorities (NMRA’s) - To build regional and national capacity to implement EAC-MRH programme - To create a platform for information sharing on the harmonized registration system to key stakeholders - To develop and implement a framework for mutual recognition of regulatory decisions based on Chapter 21, Article 118 of the East African Community Treaty CORE AREAS OF EAC- MEDICINES REGULATORY HARMONIZATION - Medicine Evaluation and Registration – lead by Tanzania (TFDA) - Good Manufacturing Practices Inspection – lead by Uganda (NDA) - Information Management Systems – lead by Rwanda (Pharmacy Task Force) - Quality Management – lead by Kenya (PPB) - Pharmacovigilance– lead by Kenya (PPB) - Medical devices – lead by Tanzania (TFDA) - Pharmaceutical Policy, Legal and Regulatory Reform, Resource Mobilization and - - - - - - Sustainability– lead by Tanzania (TFDA)