EAC-MRH Programme Regulatory Scope

  • Implementation of Pharmaceutical Policy and Legal Frameworks
  • Joint Scientific Assessment of Dossiers for Medical Products , Vaccines, and Medical Devices
  • Joint Inspection of Pharmaceutical Manufacturing Facilities
  • Joint Safety and Quality Surveillance of Medical Products
  • Joint Review of Clinical Trial Protocols and Assessment of Quality of Investigational Products
  • Joint inspections of clinical sites according to the Good Clinical Practices (GCP).
  • Listing of Medical Products which have undergone EAC Joint Scientific Review for Prioritization in National Medical Stores Department Procurement Process

 

Opportunities for Pharmaceutical Manufacturers to utilize EAC joint regulatory scheme, please see below: