Regional regulatory harmonisation initiatives: Their potential contribution to the newly established African medicines agency

by Selleckchem | Nov 30 2023

Background: Key regulatory entities can serve as building blocks for the African Medicine Agency (AMA). The aim of this study is to demonstrate how the regional medicines regulatory harmonisation programmes could contribute to its effectiveness and efficiency.

Methods: A literature search was conducted using key words to identify publications about the AMA, African Medicines Regulatory Harmonisation (AMRH) and East African Community Medicines Regulatory Harmonisation programmes (EAC-MRH) from 2009 -2023. The EAC-MRH programme experience was used to highlight the benefits and challenges of African harmonisation.

Results: As the foundation for the AMA, tAMA, the AMRH has established structures and workstreams to support its operationalisation, including 10 technical committees and 5 regional economic committees. Lessons learned from the EAC-MRH 10-year experience are being used to scale up regulatory harmonisation and could be of value to AMA harmonisation experience.

Conclusions: As of June 2023, 35 of 55 countries have either signed and/or ratified the AMA Treaty, whilst 20 have neither signed nor ratified it. An effective AMA will need strong National Medicines Regulatory Authorities as well as regional programmes and it is imperative for more well-resourced countries to ratify the treaty to ensure access to essential medical products and technologies for the African people.

Comments:

The study you've outlined focuses on the role of regional medicines regulatory harmonization programs in contributing to the effectiveness and efficiency of the African Medicine Agency (AMA). The AMA aims to establish a harmonized regulatory framework for medicines across African countries. The study uses the African Medicines Regulatory Harmonisation (AMRH) and East African Community Medicines Regulatory Harmonisation programs (EAC-MRH) as case studies to demonstrate the potential benefits and challenges of regulatory harmonization in Africa.

**Key Findings:**

1. **Foundation of AMA:** The study recognizes the importance of key regulatory entities like the AMRH as foundational building blocks for the AMA. These entities provide essential structures and workstreams for the operationalization of the AMA.

2. **Operational Structure:** The study mentions the establishment of technical committees and regional economic committees within the AMRH, emphasizing the need for structured frameworks to support regulatory harmonization efforts.

3. **Lessons from EAC-MRH:** The study highlights the lessons learned from the 10-year experience of the EAC-MRH program. These lessons are valuable for scaling up regulatory harmonization efforts at the continental level and can serve as a guide for the AMA's harmonization initiatives.

4. **AMA Treaty Status:** As of June 2023, 35 out of 55 African countries have either signed or ratified the AMA Treaty, indicating a significant level of support among African nations. However, there are still 20 countries that have neither signed nor ratified the treaty, emphasizing the need for broader participation and commitment.

**Conclusions and Recommendations:**

1. **Need for Strong National and Regional Support:** The study underscores the importance of strong National Medicines Regulatory Authorities within individual countries. These national entities, coupled with regional harmonization programs, form the backbone of an effective AMA.

2. **Call for Ratification:** The study urges more well-resourced countries to ratify the AMA Treaty. Increased participation is crucial to ensure access to essential medical products and technologies for the African population.

3. **Continued Learning from Regional Experiences:** The study suggests that ongoing learning from regional programs like EAC-MRH is essential. Understanding both the successes and challenges of these initiatives can inform the development and refinement of continental harmonization efforts.

In summary, the study provides a comprehensive overview of the role of regional regulatory harmonization programs in the context of the AMA. It emphasizes the importance of collective efforts, strong national regulatory bodies, and active participation from African nations to establish an effective and efficient regulatory framework for medicines in the continent.