The East African Community Medicines Regulatory Harmonization (EAC-MRH) Programme

  • Overview


The East Africa Community Medicines Regulatory Harmonization Programme is a regional programme that was launched on 30th March 2012 by the EAC Council of Ministers in Arusha, United Republic of Tanzania.

The goal of the programme is to facilitate access to safe, efficacious and quality essential medicines, vaccines and medical devices for treatment, management and diagnosis of conditions of public health importance. The programme does this through harmonization of regulatory requirements, guidelines, standards and tools for the EAC National Medicines Regulatory Authorities (NMRA).

 

EAC-MRH OBJECTIVES

EAC-MRH OBJECTIVES

The East African Community (EAC) Medicines Regulatory Harmonization is a regional programme and is part of the continental initiative, the “African Medicine Regulatory Harmonization (AMRH)” whose aim is to address the concerns of lack of standardized approaches in regulation of medicine, vaccines and medical devices. The main objective of the programme includes the implementation of an agreed Common Technical Document (CTD) for registration of medicines in EAC Partner States.

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EAC-MRH APPROACH

EAC-MRH APPROACH

Technical activities are executed by Heads of EAC Partner States National Medicines Regulatory Authority (NMRA) and eight expert working groups in charge of different regulatory functions including registration, Good Manufacturing Practices (GMP) inspections, pharmacovigilance, post marketing surveillance, clinical trials control, quality management system, medical devices and diagnostics and policy, legal and regulatory reforms.

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INSTITUTIONAL ARRANGEMENT

INSTITUTIONAL ARRANGEMENT

Samples textTechnical activities are executed by Heads of EAC Partner States National Medicines Regulatory Authority (NMRA) and eight expert working groups in charge of different regulatory functions including registration, Good Manufacturing Practices (GMP) inspections, pharmacovigilance, post marketing surveillance, clinical trials control, quality management system, medical devices and diagnostics and policy, legal and regulatory reforms.Samples text

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 icons8 news 1001  EAC-MRH LATEST NEWS

 

EAC PARTNER STATES NMRAS

Burundi Flag              PPBKenya                  RwandaFDA

 South Sudan Drug and Food Control Aunthority       RwandaFDA    RwandaFDA      RwandaFDA



schedule  EAC-MRH JOURNALS

  • PJ3 A new approach to an old problem: Overview of the EAC's Medicines Regulatory Harmonization initiative
    A new approach to an old problem: Overview of the EAC's Medicines Regulatory Harmonization initiative
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    Published 12 August 2020


    Category: Journals, EAC-MRH Journals
    Type: Journal
    Tag: EAC-MRH

  • PJ1 Coming together to improve access to medicines: the genesis of the East African Community's Medicines Regulatory Harmonization initiative
    Coming together to improve access to medicines: the genesis of the East African Community's Medicines Regulatory Harmonization initiative
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    Published: 12 August 2020


    Category: Journals, EAC-MRH Journals
    Type: Journal
    Tag: EAC-MRH

  • PJ5 Eight years of the EAC Medicines Regulatory Harmonization initiative: Implementation, progress, and lessons learned
    Eight years of the EAC Medicines Regulatory Harmonization initiative: Implementation, progress, and lessons learned
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    Published 12 August 2020


    Category: Journals, EAC-MRH Journals
    Type: Journal
    Tag: EAC-MRH

  • PJ2 Improving access to quality medicines in East Africa: An independent perspective on the EAC Medicines Regulatory Harmonization initiative
    Improving access to quality medicines in East Africa: An independent perspective on the EAC Medicines Regulatory Harmonization initiative
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    Published 12 August 2020


    Category: Journals, EAC-MRH Journals
    Type: Journal
    Tag: EAC-MRH

  • PJ4 Optimizing the EAC's Medicines Regulatory Harmonization initiative in 2020-2022: A Roadmap for the Future
    Optimizing the EAC's Medicines Regulatory Harmonization initiative in 2020-2022: A Roadmap for the Future
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    Published 12 August 2020


    Category: Journals, EAC-MRH Journals
    Type: Journal
    Tag: EAC-MRH


OUR DEVELOPMENT PARTNERS

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