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EAC Medicines Regulatory Guidelines

The EAC-MRH programme has developed guidelines for medicines registration, GMP inspections, pharmacovigilance, post marketing surveillance, medical devices, clinical trial control and policy frameworks.

Medicines Evaluation and Registration

Compendium of Guidelines for Marketing Authorization of Human Medicinal Products


Good Manufacturing Practices

Other Medicines Regulatory Guidelines


Clinical Trial Control

  • Guidelines on Submission Application for Clinical Trials

  • Clinical Trial Application Checklist

  • Clinical Trial Application Form

Post Marketing Surveillance

  • Regional Strategy for Post Marketing Surveillance of Medical Products


All rights reserved:
These controlled documents. They must not be copied without authorization from the EAC Secretariat. Only originals or authorized copies shall be used as working documents.