EAC Medicines Regulatory Guidelines

Posted in MRH Programme

The EAC-MRH programme has developed guidelines for medicines registration, GMP inspections, pharmacovigilance, post marketing surveillance, medical devices, clinical trial control and policy frameworks.

• Ministerial Communique on Advocacy and Support for the Harmonization and Strengthening of Medicines Regulation in the East African Community Partner States and the African Continent
  

Medicines Evaluation and Registration

Compendium of Guidelines for Marketing Authorization of Human Medicinal Products

Good Manufacturing Practices

Other Medicines Regulatory Guidelines

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. 

EAC-MRH Programme Regulatory Scope

Posted in MRH Programme

• Implementation of Pharmaceutical Policy and Legal Frameworks
• Joint Scientific Assessment of Dossiers for Medical Products , Vaccines, and Medical Devices
• Joint Inspection of Pharmaceutical Manufacturing Facilities
• Joint Safety and Quality Surveillance of Medical Products
• Joint Review of Clinical Trial Protocols and Assessment of Quality of Investigational Products
• Joint inspections of clinical sites according to the Good Clinical Practices (GCP).
• Listing of Medical Products which have undergone EAC Joint Scientific Review for Prioritization in National Medical Stores Department Procurement Process

Opportunities for Pharmaceutical Manufacturers to utilize EAC joint regulatory scheme, please see below:

• Link for Expression of Interest for Submission of Applications for Marketing Authorization of Medicinal Products
  
  
• Invitation for Expression of Interest (EOI) for Submission of Active Pharmaceutical Ingredient Master File (APIMF) to the EAC
  
  
• Submission of Applications for Marketing Authorization of Vaccines for Prevention of Covid-19
  
  
• Link for Submission of Applications for EAC Joint GMP Inspections
  
  
• Link for Submission of Applications for EAC Joint Safety Inspection
  
  
• Link for Submission of Applications for EAC Joint Inspection of Clinical Trial Sites

EAC-MRH Programme Milestones

Posted in MRH Programme

Some of the key milestones include:

• Establishment of Zanzibar Food and Drugs Agency -ZFDA, 2017; Rwanda Food and Drugs Authority-Rwanda FDA, 2018 and Burundi National Medicines Regulatory Authority, 2021;
  
  
• Development and Domestication of EAC Common Technical Document (CTD) for Registration of Medical Products;
  
  
• EAC GMP Standards for Pharmaceutical Manufacturers;
  
  
• EAC Harmonized Compendium on Safety and Vigilance of Medical Products and Health Technologies;
  
  
• Regulatory Framework for Medical Devices including in-Vitro Diagnostic Medical Devices;
  
  
• Requirements for Assessment and Market Authorization of In Vitro Diagnostic Medical Devices;
  
  
• EAC Medicines and Health Technologies Policy and Strategy (2018-2022);
  
  
• EAC Post-Marketing Surveillance Strategy (2019-2023)

EAC-MRH Programme Institutional Arrangement

Posted in MRH Programme

EAC Summit of Heads of State

The Summit provides highest political leadership and direction on Health Sector Investment Priorities , specifically on Increase Access to Efficacious and Affordable Medicines, Vaccines and other Health Technologies focusing on Malaria, Tuberculosis, HIV/AIDS , COVID-19 and other emerging diseases.

EAC Council of Ministers

The EAC Council of Ministers approve and adopt key policy instruments for domestication by EAC Partner States. The Council is also responsible for allocation of resources for all EAC regional programmes and projects. Issue directive and decisions in line with Treaty for Establishment of the East African Community. The decisions and directives of the Council of Ministers are informed by the Policy guidance from relevant Sectoral Councils such as Health, Industry and others.

EAC Sectoral Council of Ministers of Health

The EAC Sectoral Council of Ministers responsible for Regional Cooperation on Health shall set overall policy and direction of the programme. The Forum of Heads of NMRA and Project Steering Committee will make decisions concerning implementation of the project including technical matters and will report progress to the EAC Sectoral Council  on Health and thereafter the matter shall be forwarded to the EAC Council of Ministers. Any decision endorsed by the EAC Council of Ministers becomes mandatory in all EAC Partner States.

Project Steering Committee

The Project Steering Committee (PSC) will be responsible for approval of annual work plans, budgets and technical oversight of the project. The committee shall comprise of the Chief Pharmacists and Heads of National Medicines Regulatory Authorities from the EAC Partner States.  EAC Secretariat shall be secretariat to the committee.

Forum of Heads of NMRA

Comprise of the chief executive officers of the EAC Partner States National Medicines Regulatory Authorities and are responsible for provision of overall leadership and technical oversight of the programme.

Regional Experts Working Groups (EWGs)

Comprised of Partner States Experts from EAC NMRA and they responsible for development and implementation of harmonized regulatory guidelines and procedures for medical products , vaccines and health technologies.

Project Coordination Team

The Project Coordination Team comprises of EAC technical staff drawn from Health, Finance, Information Technology Departments. The team manages and monitors the day today work programs and schedules of project components.

EAC-MRH Programme Approach

Posted in MRH Programme

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.

The EAC-MRH Programme works closely with some of following key stakeholders:

• EAC Partner States’ National Medicines Regulatory Authorities;
  
  
• Pharmaceutical Industries;
  
  
• Technical Partners such as the World Health Organization (WHO), African Union Development Agency -New Partnership for Africa’s Development (AUDA-NEPAD) and Switzerland Therapeutic Agency; and
  
  
• Development Partners such as Bill and Melinda Gates Foundation (BMGF), Swiss Development Corporation (SDC), United States Agency for International Development (USAID), the World Bank, United Kingdom Department for International Development, United States Pharmacopoeia, ....

Objectives of the EAC-MRH Programme

Posted in MRH Programme

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 is to:

• Implement an agreed Common Technical Document (CTD) for registration of medicines in EAC Partner States;
  
  
• Implement a common information management system for medicines registration in each of the EAC Partner States’ National Medicines Regulatory Authority (NMRA) which is linked in all Partner States and EAC Secretariat;
  
  
• Implement a quality management system in each of the EAC Partner States’ NMRA;
  
  
• Build regional and national capacity to implement medicines regulatory harmonization in the EAC region;
  
  
• Create a platform for information sharing on the harmonized medicines registration system to key stakeholders at national and regional levels; and
  
  
• Implement a framework for mutual recognition of medicines registration based in accordance with Article 118 of the Treaty for the establishment of the East African Community.

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
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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
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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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