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.

OBJECTIVES

  1. To implement a common technical document for registration of medicines
  2. To implement a common information management system (IMS) for medicines registration
  3. To implement a quality management system in each EAC Partner States National Medicines Regulatory Authorities
  4. To build regional and national capacity to implement EAC-MRH programme
  5. To create a platform for information sharing on the harmonized registration system to key stakeholders
  6. To develop and implement a framework for mutual recognition of regulatory decisions based on Chapter 21, Article 118 of the East African Community Treaty

Regulatory Scope

  1. Medicines Evaluation and Registration
  2. Good Manufacturing Practices Inspection
  3. Pharmacovigilance and Post marketing Surveillance
  4. Medical Devices and In vitro Diagnostics
  5. Pharmaceutical Policy, Legal and Regulatory Framework
  6. Joint review of Clinical Trials

FOCUS

  1. Establishment of regional registration platforms
  2. Development of Common requirements and guidelines
  3. Joint assessments and inspections
  4. Work sharing, mutual recognition and pooling of resource
  5. Streamlined decision making processes

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