Overview

Africa's livestock sector is vital, supporting over 350 million people and contributing significantly to food security and economic resilience. Despite its importance, the sector faces persistent challenges, particularly the lack of a harmonised framework for regulating veterinary products.

This gap has resulted in inefficiencies, fragmented regulatory systems, and ultimately limited access to quality veterinary products, which are crucial for preventing and controlling livestock diseases and boosting productivity. The lack of harmonised frameworks also facilitates uncontrolled imports and misuse of antimicrobials, often through farmer self-medication due to limited affordable access to quality veterinary products and veterinary service providers. 

Background

In July 2023, the African Union Pan African Veterinary vaccine Centre (AU-PANVAC) convened a meeting of veterinary medicine manufacturers and regulators on the Harmonization of Standards for Vaccine Registration and Certification of Vaccine Manufacturing Facilities in Abuja, Nigeria. Key outcomes from this meeting included the recognition of the need for:

  • Establishing a network of regulatory authorities for knowledge exchange and collaboration;
  • Strengthening AU-PANVAC’s role in auditing and ensuring quality control;
  • Promoting Good Manufacturing Practices (GMP) and regional mutual recognition of standards;
  • Securing political support for enforcing harmonised standards across Africa.

Building on the Abuja meeting resolution to establish the continental network of regulatory authorities for veterinary products, AU-IBAR and AU-PANVAC have developed a concept note to inform the  establishment  of a Pan-African network of veterinary products regulatory agencies to facilitate the exchange of information,  harmonise regulatory standards, enhance the capacity of national regulatory authorities for better assessment and inspection of veterinary products’  manufacturing facilities, and enhance transparency by improving communication between regulatory authorities, manufacturers and stakeholders.  

Similarly, recognising that there is currently no overarching framework for cooperation between NMRAs responsible for veterinary medicines in Africa, implemented by GALVmed in partnership with the World Organisation for Animal Health (WOAH), the UK Veterinary Medicines Directorate (UK-VMD), and the East African Community (EAC), seeks to support the development of a long-term institutional arrangement to improve access to high quality veterinary medicines through better regulation across sub-Saharan Africa in a coordinated manner. GALVmed commissioned a comprehensive study to assess the feasibility of creating a governance structure to improve veterinary medicine regulation across Africa. 

Recognising the synergy between the two initiatives “Establishing a Network of Regulatory Authorities in Africa” by AU-IBAR/AU-PANVAC and the “Establishment of a long-term Governance Structure for Better Regulation of Veterinary Medicines in sub-Saharan Africa” led  by GALVmed, it is proposed that the two initiatives collaborate to establish a continental regulatory network on veterinary products under the auspices of the African Union with technical and strategic support from GALVmed in partnership with WOAH, and UK-VMD. At the Africa Union level, the process will be coordinated jointly by AU-IBAR and AU-PANVAC. 

This meeting presents a critical opportunity to align stakeholders on the proposed network of regulatory authorities and associated governance structure for veterinary medicine regulation across Africa. By fostering collaboration and building consensus, the initiative will lay the groundwork for enhanced access to high-quality veterinary medicines, improving livestock health, productivity, and food security across the continent. 

Objectives

This three-day consultative meeting will bring together Heads of National Medicines Regulatory Authorities (NMRAs), Chief Veterinary Officers (CVOs), and other key stakeholders. The objectives of the consultative meeting are: 

Present Findings

Share the results of the GALVmed-commissioned study on creating a network of regulatory agencies and associated governance structure for veterinary medicine regulation in Africa.

Facilitate Discussion

Provide a platform for stakeholders to discuss the study's recommendations and implications for regulatory frameworks.

Build Consensus

Develop a unified position on the proposed Network of Regulatory Authorities and associated governance structure and outline concrete steps for its creation, Terms of Reference and mode of operation.

Strengthen Collaboration

Foster collaboration between NMRAs, CVOs, regional economic communities, international organisations and other relevant stakeholders to support the harmonisation of veterinary medicine regulations.

Agreement on Contribution

Agree on how the Network of Regulatory Authorities can contribute to the One Health agenda within Africa by minimising the risks of antimicrobial resistance arising from the use of veterinary medicinal products in animals.

Expectations

Expected Outcomes

1. A shared understanding of the study findings and key recommendations.

2. Consensus on the proposed Network of Regulatory Authorities, its Terms of Reference (TOR), associated governance structure and roadmap for establishment including identification of key capacity-building needs and next steps for implementation.

3. Strengthened collaboration among stakeholders to advance the Better Regulation Project's goals of improving the availability of high-quality veterinary medicines in Africa.

4. A statement of the approach that will be followed by the Network to ensure that the TOR and roadmap/work plan will contribute to the wider One Health agenda by reducing the risks of AMR arising from the use of veterinary medicines considering African realities, including insecure supply chains, the role of Community Animal Health Workers (CAHWs), and disparities in laboratory capacity.

Expected Outputs

1. A resolution to create a Network of Regulatory Authorities together with an associated governance structure based on shared understanding and alignment on Terms of Reference and other material terms.

2. A report of the meeting to be disseminated to stakeholders.