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
Part I
Parts II and III
Part II: EAC Guidelines on Stability Testing Requirements for Active Pharmaceutical Ingredients (APIs) and Finished Pharmaceutical Products (FPPs) )
Part III: EAC Guidelines on Therapeutic Equivalence
- Annex I: Dissolution Testing and Similarity of Dissolution Profiles
- Annex II: Bioequivalence Study Requirements for Different Dosage Forms
- Annex III: Biopharmaceutics Classification System (BCS) Based Biowaiver
- Biowaiver Application Form
- Annex IV: Selection of a Comparator Product to be used in Establishing Interchangeability
- Annex V: Bioequivalence Trial Information (BTIF)
Parts IV to XI
Part XII
Part XII: EAC Procedure on Evaluation of Quality of Active Pharmaceutical Ingredient
- Guidelines for Active Pharmaceutical Ingredient Master File Procedure
Vaccines, Biotherapeutics and Variations
- Guidelines for Submission of Application for COVID-19 Vaccines
- AVAREF Guidelines
- WHO Guidelines
- Guidelines for Renewals
- Register of Products that have been approved for Marketing Authorization
- Infographic for EAC Joint Assessment Procedure
- Notice to Applicants (for both FFP & APIMF)
- Expression of Interest for FPP
- Expression of Interest for APIMF
- FAQ
Good Manufacturing Practices
- Basic Requirements for Implementation of Good Manufacturing Practices
- Annex 1: Manufacture of Strerile Medicinal Products
- Annex 2: Manufacture of Biological Products for Human Use
- Annex 3: Qualifications and Validation
- Annex 4: Computerized Systems
- Annex 5: Water for Pharmaceutical Use
- Annex 6: Heating, Ventilation and Air-Conditioning Systems for Non-Sterile Pharmaceutical Dosage Forms
- Annex 7: Authorized Persons
- Annex 8: Quality Risk Management (QRM)
- Annex 9: Active Pharmaceutical Ingredients
- Annex 10: Waste Management for Medicinal Product Manufacturers
- Guideline for Preparation of Site Master File For Pharmaceutical Manufacturing Facilities
- Application Form for EAC Joint GMP Inspection for Finished Pharmaceutical Products and Active Pharmaceutical Ingredients Manufacturing Facilities
- Checklist for EAC Joint GMP Document Evaluation for Finished Pharmaceutical Products & Active Pharmaceutical Ingredients Manufacturing Facilities
- Flow chart for EAC Joint GMP Inspection
Other Medicines Regulatory Guidelines
Medical Devices and In-Vitro Diagnostics
- EAC Regulatory Framework for Medical Devices Including In-Vitro Diagnostics
- Requirements for Assessment and Market Authorization of In-Vitro Medical Devices
- Summary Technical Documentation (STED) for In-Vitro Diagnostics Dossier
- Application Form for Market Authorization of In-Vitro Diagnostics
- Essential Requirements Checklist for In-Vitro Diagnostics
- Post Market Surveillance Annual Report Submission Form>
- Reporting Form for Variation of In-Vitro Diagnostics Which Have Been Issued Market Authorization
- Classification Rules for In-Vitro Diagnostic Devices
- WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices
- Africa Medical Devices Forum (AMDF) Guidance on Assessment of Medical Devices including Diagnostic Tests Donations for in-Country use during Emergencies
- Africa Medical Devices Forum (AMDF) Reporting Form For Complaints For Medical Devices Including In-Vitro Diagnostics
Pharmacovigilance
- Guidelines on Safety and Vigilance of Medical Products and Health Technologies
- Harmonized Indicators for Assessing and Monitoring Pharmacovigilance Systems in the East African Community Partner States: User Manual
- Adverse Drug Reaction (ADR)/ Adverse Event Following Immunization (AEFI) Form
- Patient Adverse Drug Reactions Reporting Form
- Medical Devices Adverse Event/Incident Reporting Form
- Product Quality Reporting Form
- Patient Adverse Drug Reaction (ADR) Alert Card
- Format and Content of the Protocol of Non- Interventional Post-Authorization Safety studies
- Format of the Pass Final Study Report
- Methodological Aspects of Signal Detection from Spontaneous Reports of Suspected Adverse Reactions
- Format and Layout of Pharmacovigilance System Master File (PSMF)
- Pharmacovigilance Methods
- Direct Healthcare Professional Communication Plan
- Template for Direct Healthcare Professional Communication
- Standalone Signal Notification for Active Substance/ International Non-Proprietary Name- Brand name
- Pharmacovigilance Business Plan
Active Pharmaceutical Ingredient Master File
- Application form for Active Pharmaceutical Ingredient Master File (APIMF) in the EAC
- Cover Letter for Active Pharmaceutical Ingredient Master File (APIMF) Application
- EAC Screening Template for Active Pharmaceutical Ingredient Master File (APIMF)
- Procedure for Submission of EAC Active Pharmaceutical Ingredient Master File (EAC-APIMF)
- Invitation for Expression of Interest (EOI) for the Submission of Active Pharmaceutical Ingredient Master File (APIMF) to the EAC
Policy and Legal Frameworks
- EAC Medicines and Health Technologies Policy
- EAC Medicines and Health Technologies Strategic Plan (2018-2022)
- EAC Technical Cooperation Framework Agreement for National Medicines Regulatory Authorities (NMRAs)
- EAC Regional Pharmaceutical Manufacturing Plan of Action (EAC-RPMPoA 2017-2027)
- EAC Heads of State Health Sector Investment Priorities and Framework (2018-2028)
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.