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

Posted in MRH Programme

The East Africa Community Medicines Regulatory Harmonization Programme is a regional programme that was launched on 30^th 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

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

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

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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   EAC-MRH LATEST NEWS

EAC Health Ministers adopt a Regional Policy Framework for the supply and production of antibiotics

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   EAC-MRH UPCOMING EVENTS

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EAC PARTNER STATES NMRAS

                               

                 

  EAC-MRH JOURNALS

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  A new approach to an old problem: Overview of the EAC's Medicines Regulatory Harmonization initiative

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  Published 12 August 2020

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

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  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

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

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  Eight years of the EAC Medicines Regulatory Harmonization initiative: Implementation, progress, and lessons learned

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  Published 12 August 2020

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

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  Evaluation of the effectiveness and efficiency of the East African community joint assessment procedure by pharmaceutical companies: Opportunities for

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  Published 03 November...

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

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  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

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

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  Optimizing the EAC's Medicines Regulatory Harmonization initiative in 2020-2022: A Roadmap for the Future

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  Published 12 August 2020

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

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  Regulatory performance of the East African Community joint assessment procedure: The way forward for regulatory systems strengthening

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  Published 16 March 2023

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

   JOINT ASSESSMENT UPDATE

List of Medicinal Products recommended for
Marketing Authorization through the EAC Joint
Scientific Assessment Procedure - November 2023

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