SSA INITIATIVES
Inventory of initiative on improving the regulation of Veterinary Medicinal Products (VMPs) in Sub Saharan Africa (SSA)
This inventory is a self-reporting tool that identifies and collates active national, continental, and international programmes/projects in SSA that address improving VMP regulation.
The inventory includes:
- Name of the initiative.
- Short descriptive information about the initiative, programme, or project. It also includes information on the country(ies) or region(s) involved.
- The start and end date of the initiative, programme, or project.
- The contact details of the initiative, programme, project coordinator or a link to its web page (if available).
An intent of establishing the inventory is to facilitate coordination and co-operation across programmes, thereby encouraging collaboration, facilitating targeted support, minimising duplication of efforts, maximising impact, and strengthening overall delivery for the continent.
Amendments and additions to this inventory should be sent to international@vmd.gov.uk.
Please note that the inventory only includes initiatives that have a veterinary medicines regulatory component in relation to SSA, such as harmonisation initiatives, regulatory policies and guidelines and capacity building etc. This inventory does not cover other programmes in SSA not specifically aimed at improving the regulation of VMP, for example training on the use laboratory equipment.
The activities covered are current. Entries will be archived once they have been completed. However, archived entries can still be viewed by users.
Initiatives
West African Economic and Monetary Union (WAEMU) Centralised procedure for the authorisation of the VMPs
Description
A grouping of eight countries (Benin, Burkina Faso, Côte d’Ivoire, Guinea-Bissau, Mali, Niger, Senegal and Togo) established harmonisation of VMP legislation and the institutional mechanisms for a centralised system of authorisation of VMPs in member countries. The Secretariat of the Regional Committee for Veterinary Medicinal Products (CRMV) manages the process. While the system is established and functional, support is required in the areas of inspections and enforcement.
Period
Start date: March 2006
End date: Ongoing
Contact
Dr Domagni – CRMV
ktdomagni@uemoa.int
www.uemoa.int
The East African Community (EAC) Mutual Recognition Procedure (MRP)for harmonisation of registration of veterinary Immunological and Pharmaceutical products in EAC
Description
The EAC MRP was established with the overall goal of improving access to good quality of Immunological and Pharmaceutical Veterinary Products at lesser cost to customers.
The main objectives set to meet this goal were:
- To establish harmonised Immunological and Pharmaceutical veterinary medicines registration systems within the EAC in accordance to national and international recognised standards and best practices.
- To reduce duplication of effort through joint assessments and joint site inspections.
It involves Tanzania, Kenya, Uganda, Rwanda, Burundi and South Sudan and is being delivered by GALVmed and the EAC secretariat. The coordinator’s role is currently supported by GALVmed.
Period
Start date: November 2014
End date: Ongoing
Contact
Elizabeth Okello – GALVmed
Further information can be found at: www.tmda.go.tz
Southern Africa Development Community (SADC) Harmonisation of VMP registration
Description
Following the World Organization for Animal Health (OIE)’s work in the Southern Africa Development Community (SADC) region in 2017 in collaboration with OIE Collaborating Centers, French Agency for Food, Environmental and Occupational Health & Safety (ANSES), and Unites States Food and Drug Administration (USFDA), on the harmonisation of VMP registration in the region. A consultant was hired to determine the degree of implementation of the guidelines. A report of the implementation is being finalised.
Period
Start date: 2017
End date: 2021
Contact
Mária Szabó
m.szabo@oie.int
Internationally harmonised pharmacovigilance (PhV)
Description
A Training manual, “How to set up a pharmacovigilance system for veterinary medicinal products” was developed for a basic PhV system that is aligned to the Veterinary International Conference on Harmonization (VICH) standards, and other training materials (Power Points and case studies). Training delivered at VICH Outreach Forum (VOF), World Organization for Animal Health (OIE) 6th Cycle Focal Points-VMPs, Association of Southeast Asian Nations (ASEAN) Focal Points -VMPs. Also, a focus on Middle East and North Africa (MENA) region.
Period
Start date: 2018
End date: Ongoing
Contact
Rick Clayton – HealthforAnimals
rick@healthforanimals.org
Development of the Ethiopian National Veterinary Medicines List
pDescription
Ethiopian National Veterinary “Medicines List” prepared and validated and printed. This initiative is supported by the Food and Agriculture Organization of the United Nations (FAO).
Period
Start date: 2018
End date: June 2021
Contact
Tenaw Tadege
tenaw.tadege@fao.org
Gijs Vantklooster
gijs.vantklooster@fao.org
Southern Africa Development Community (SADC) VMP Collaborative Initiative (ZAZIBONA) - Pilot Stage
Description
This is a pilot initiative on the harmonisation of VMP regulations involving the ZAZIBONA+ countries (Zambia, Zimbabwe, Botswana, Namibia, Malawi, and South Africa). Currently Heads of Agencies (HOAs) of Botswana and Zimbabwe expressed preparedness to host/fund initial physical conferring fees. All Member states prepared to support officers to travel to these initial physical sessions. A Technical Working Group has been set up to coordinate the activities. The project currently has no sponsors.
Period
Start date: 2020
End date: Ongoing
Contact
Dr Zivanai A. Makoni – Zimbabwe (Chair of the Technical Working Group)
zmakoni@mcaz.co.zw
Regional/Common labels
Description
The administrative effort and cost of printing country specific labels may not be justified in small Sub Saharan Africa (SSA) markets. An analysis of the situation and feasibility of common regional labels will be investigated and reported.
Period
Start date: 2020
End date: March 2021
Contact
Rick Clayton – HealthforAnimals
rick@healthforanimals.org
Liezl Kock – HealthforAnimals
liezl@healthforanimals.org
Good Manufacturing Practice (GMP) Inspections
Description
Delays in GMP inspections and reports are detrimental to the registration process in SSA. On-line training is being finalised for the EAC MRP for GMP inspections.
Period
Start date: 2020
End date: March 2021
Contact
Liezl Kock, HealthforAnimals
liezl@healthforanimals.org
Global veterinary dossier format
Description
Dossier structures from many regions are being mapped and analysed for commonalities in order to propose a single global dossier structure. The use of this structure will increase the efficiency of international regulatory procedures.
Period
Start date: 2020
End date: 2021
Contact
Rick Clayton – HealthforAnimals
rick@healthforanimals.org
Harmonising Regulation of Foot and Mouth Disease (FMD) Vaccines in Eastern Africa, The AgResults FMD Vaccine Challenge Project
Description
The AgResults Initiative (“AgResults”) is a multilateral initiative financed jointly by the governments of Australia, Canada, the United Kingdom, the United States, and the Bill & Melinda Gates Foundation that uses Pay-for-Results prize competitions to incentivize, or “pull”, the private sector to overcome agricultural market barriers by investing in innovative research and delivery solutions that improve the lives of smallholder farmers.
It involves, Burundi, Ethiopia, Kenya, Rwanda, Tanzania and Uganda. It is being delivered by GALVmed.
Period
Start date: February 2020
End date: February 2028
Contact
Project manager: Nina Henning
FMDchallenge@galvmed.org
Further information available at: https://www.galvmed.org/wp-content/uploads/2020/02/FMD-Vaccine-Challenge-Project-EOI.pdf
Development of National Chemical residues and biological hazard in livestock products and feed monitoring plan.
Description
Sampling and testing of livestock products and feed for veterinary medicines residues as part of a wider programme on chemical residues and biological hazards testing.
Development of National residue monitoring plan for livestock products and feed developed (draft) for Ethiopia. This initiative is supported by the Food and Agriculture Organization of the United Nations (FAO).
Period
Start date: August 2020
End date: Ongoing
Contact
Gijs van ‘t Klooster/Hassen Chaka’
Gijs.vantklooster@fao.org
World Organization for Animal Health (OIE) 7th cycle training seminars
7th Cycle training seminars will be continued when the 6th cycle has been accomplished in all Regions.
“How to set up a pharmacovigilance system for veterinary medicinal products” document was included into the program of the 6th Cycle training seminars/webinar and disseminated to all Focal Points to the five OIE Regions in order to obtain feedback and publish a consolidated version to include the OIE Focal Points views.
A session on the regulation and quality of VMPs is being considered as part of the 7th cycle training.
Period
Start date: 2021
End date: 2022
Contact
Mária Szabó
m.szabo@oie.int
The Antimicrobial Resistance (AMR) Multi-Partner Trust Fund (MPTF) project
A Tripartite partnership between World Organization for Animal Health (OIE), World Health Organization (WHO) and The Food and Agriculture Organization of the United Nations (FAO), Emergency Centre for Transboundary Animal Diseases (ECTAD) Kenya will work with the Veterinary Medicines Directorate (VMD) Kenya which will enforce regulation of veterinary medicines and coordinate collection of Antimicrobial usage (AMU) data. This will include support for VMD to develop a reporting system and database for antimicrobial consumption. This is part of a broader AMR programme.
This project is also funded by the United States Agency for International Development (USAID)-funded Global Health Security Agenda (GHSA) AMR Action Package.
Period
Start date: 2021
End date: June 2023
Contact
Michael Apamaku
michael.apamaku@fao.org
Sub Saharan Africa (SSA) Veterinary Medicinal Products (VMP) regulation harmonisation options analysis project second phase (SSA 2)
Description
This project is a continuation to the first phase of the SSA project (SSA 1) which looked at prospects for regulatory harmonisation/convergence in SSA. SSA 2 is intended to pave the way for the implementation of the findings of SSA 1 by exploring the requirements for the development, and securing high-level agreement to the use of:
- Self-Assessment/Benchmarking tool to measure the maturity of SSA national VMP regulatory authorities – this should help with evidencing the success of future initiatives.
- Common application form for VMP registration in SSA.
- An online submission portal for VMP registration in SSA.
- Conducting a deeper/closer examination of East African Community (EAC) Mutual Recognition Process (MRP) and West African Economic and Monetary Union (WAEMU) centralised VMP authorisation procedures.
- Creating an inventory of previous and current international initiatives and activities in SSA aimed at improving VMP regulation and a database of SSA national VMP regulators.
This project involves all the SSA countries with a particular focus on the mainland countries. The project is sponsored by the Bill & Melinda Gates Foundation and delivered by the Veterinary Medicines Directorate (VMD) UK.
Period
Start date: July 2020
End date: June 2021
Contact
Project Lead: Noel Joseph
Project Manager: Adesola Tolefe
international@vmd.gov.uk
Further information on Phase 1 of the project (SSA 1) can be found here.