This is the intro text for the page MRH programme

The East Africa Community Medicines Regulatory Harmonization Programme is a regional programme that was launched in March, 2012 in Arusha Tanzania

The project was meant to address some of the key weakenesses faced by the seven National Medicine Regulatory Authorities (NMRAs) in the region in developing and implementing medicine registration procedures compatible with international accepted standards.

MER Compendium

  1. MER Guidelines
  2. MER Checklists and Forms
  3. EOI
  4. Notice to Applicants
  5. Reports
  6. Flow Chart of EAC Joint Medicine Registration Procedure
  7. Medicine registration Status
  8. MA letters
  9. MER FAQs
  10. Good Manufacturing Practices

GMP compendium

  1. GMP Guidelines
  2. GMP Inspection checklists and forms
  3. GMP Schedule of Inspection
  4. GMP Certified sites
  5. GMP Sites under CAPA
  6. GMP Certificates
  7. GMP Reports
  8. GMP FAQs

Pharmacovigilance

  1. PV Compendium of Guidelines
  2. PV Tools
  3. PV Forms
  4. PV Reports
  5. PV Reports
  6. PV FAQs

Post Marketing Surveillance

  1. PMS Strategy
  2. PMS Reports
  3. PMS Alerts

Medical Devices

  1. MD Guidelines
  2. MD Reports
  3. MD FAQs

Clinical Trials and Oversight

  1. Clinical Trial guidelines
  2. Clinical Trial Reports
  3. Clinical trial FAQs

Policy, Legal and Regulatory Frameworks

  1. Medicines and Health Technologies Policy and Strategic Plan
  2. Technical Cooperation Agreement for EAC Partner States NMRAs
  3. Reports
  4. FAQs

OUR DEVELOPMENT PARTNERS

EAC PARTNER STATES NMRAS

TALK TO US

  • Website: www.mrh.eac.int
  • Email: eacmrh@eachq.org
  • Location: Kilimanjaro Wing, 5th Floor, Room 552
  • Connect with Us:
  • Facebook: eacmrh.programme
  • Linkedin: eac-mrh
  • Twitter: @eacmrh