Breaking new ground in the regulatory environment: the EAC Mutual Recognition Procedure expands its product scope to include veterinary ectoparasiticides

In sub-Saharan Africa, obtaining approval to sell veterinary medicines in the market requires applying for a marketing authorisation separately in each country where the product is to be sold. This is often a lengthy, resource-intensive process that discourages private sector investment, hence limiting the sustainable supply of veterinary medicines.  

Since 2010, GALVmed and its partners, AU-PANVAC and HealthforAnimals, have been supporting the East African Community (EAC) to implement a mutual recognition procedure (MRP) in the EAC Partner States that allows for simultaneous application of marketing authorisations in multiple countries. This saves time and allows countries and applicants to use their resources more efficiently.

In 2022, GALVmed contracted a consultant to conduct a landscape analysis of veterinary ectoparasiticides (pesticides) regulation in six Partner States (Burundi, Kenya, Rwanda, south Sudan, Uganda, Rwanda and the United Republic of Tanzania). The analysis reported several areas of divergence in the region in the regulation of these products. This informed the need to harmonise the veterinary ectoparasiticides regulation and in order to implement the EAC Council of Ministers directive, EAC secretariat with support from GALVmed, TradeMark Africa (TMA)  and The United States Agency for International Development (USAID) developed working documents under the MRP initiative to harmonise regulation.

 As of June 2024, this novel initiative has been extended to also include registration of veterinary ectoparasiticides, thereby allowing companies to submit these products for registration through the MRP system. The draft guidelines and other key technical documents have been approved, and current efforts are aimed at capacity building related to initial training of veterinary ectoparasiticides dossier assessors.

An initial six days workshop took place in Dar Es Salaam, Tanzania on 18th-24th July to build institutional capacity and application of best practices for the evaluation and registration of veterinary ectoparasiticides to safeguard human health, animal health and the environment. This will enhance capacity of veterinary pesticides assessors on risk assessment and dossier evaluation to improve public trust in the MRP process, which will attract submission of safe, quality and efficacious veterinary pesticides in the region.

The meeting was attended by MRP members from veterinary medicine regulatory authorities drawn from Democratic Republic of Congo, Burundi, Kenya, Rwanda, Tanzania, Uganda and South Sudan. The training was conducted by representatives from Australian Pesticides and Veterinary Medicines Authority and EAC Secretariat.

MRP represents a key advancement in harmonising and strengthening veterinary product registration by reducing the time, costs, and resources needed to bring these medicines to market. By streamlining approvals and extending to new product categories like ectoparasiticides, this initiative enhances availability and access to essential animal health solutions, supporting animal health, livestock production, strengthening the livelihoods of farming communities, and contributing to sustainable development.

Stronger regulations would bolster food security and livelihoods in Africa

Originally published by S&P Global. Written by Lois Muraguri, Senior Director of Enabling Environment & Partner Engagement.

Across the African continent, livestock are one of the leading sources of food security and resilient livelihoods. Livestock production contributes 30-80% of the continent’s total agricultural gross domestic product (GDP) and provides jobs and nutrition for millions. Yet, Africa’s livestock sector faces several growing challenges – not least the spread of diseases, which threaten to disrupt the incomes and livelihoods of rural communities.

Diseases like foot-and-mouth disease, Newcastle disease and peste des petits ruminants cause widespread animal and productivity losses across the continent. In total, more than 20% of the world’s animal production is lost to animal diseases, with the burden exceptionally higher in regions like sub-Saharan Africa.

In most cases, veterinary medicines and vaccines are a vital solution to these challenges, helping to safeguard the livelihoods and food supply that livestock provide. Yet, across Africa, the regulatory frameworks by which new veterinary medicines can be registered and approved to address these challenges are either outdated, ineffective or simply non-existent.

In the last decade, great strides have been made to improve regulatory frameworks in sub-Saharan Africa. There have been various initiatives aimed at improving the regulation of veterinary medicines in sub-Saharan Africa. Most of these, such as initiatives under HealthforAnimals, have focused on improving capability of regulators through training and offering technical assistance on specific areas. Others, such as the UK’s Veterinary Medicines Directorate’s sub-Saharan Africa program, have looked at options for regulatory harmonization. These, plus efforts by the WOAH and others, have raised awareness and increased understanding of the need for improving regulatory frameworks in sub-Saharan Africa. 

With climate change and accelerating continental trade hastening the spread of livestock diseases, Africa needs a functioning regulatory environment for veterinary medicines. An efficient regulatory framework benefits all players – regulators, product manufacturers and ultimately, livestock producers and farmers. In the last decade, great strides have been made by regulators. A functioning regulatory framework will help to equip livestock producers with quality products, supporting them to protect their livelihoods and their vital contributions to continental food security.

To begin with, a functioning and harmonized regulatory environment for veterinary medicines can unlock further private-sector investment, which has been constrained across the continent. At present, animal health companies are discouraged from registering their products in some countries across sub-Saharan Africa. Global and local companies alike face significant regulatory and commercial barriers. This is in part because of unclear and unpredictable regulatory frameworks, which are often driven by limited capacity to assess the safety and efficacy of veterinary medicines.

Creating a functioning environment for regulating veterinary medicines will begin to address private sector concerns, enabling animal health companies and manufacturers to invest and register new products that are subsequently adopted by Africa’s livestock keepers.

Regulation of novel and cutting-edge technologies requires experienced regulators to assess the next generation of innovations. Africa’s regulatory agencies often lack the necessary expertise and resources to efficiently regulate novel, innovative veterinary products thereby reducing the likelihood of these products’ availability in African markets. Similarly, for emerging diseases, the lack of a long-term market and clear regulatory pathway inhibits the development of vaccines.

Void for vet meds

The lack of safe, quality, effective veterinary products creates a void that is currently being filled by poor-quality counterfeit products, which do not offer benefits to livestock producers and whose ineffectiveness may instead undermine confidence in the effects and benefits of livestock vaccination. Similarly, regulators in sub-Saharan Africa facing inefficient regulatory systems encounter numerous challenges that affect various aspects of public health, animal welfare and the economy. The prevalence of substandard, counterfeit products is not an issue for livestock producers and private sector only – these products hamper regulators’ disease control efforts. Inefficient systems discourage private sector investment which leads to potential loss of revenues from registration fees and taxes. Ineffective regulation can adversely affect livestock health leading to lower productivity, higher mortality rates and economic losses for farmers ultimately resulting in lower national productivity.

By unlocking greater investment from animal health companies through a functioning regulatory environment, we can also deliver multiple benefits for the African continent’s millions of livestock producers. Due to the inadequate existing regulatory framework, Africa’s livestock producers typically do not have adequate access to medicines or cannot be sure of their quality, with many therefore choosing not to vaccinate their animals.

Yet we know losses from livestock diseases can be preventable – if only farmers can be made aware and assured of the quality of these medicines. A more predictable and clear registration process for new veterinary medicines can therefore improve the availability of quality veterinary medicines, whose use can prevent livestock disease, improve livestock production and boost producers’ incomes.

A well-functioning regulatory system provides immense benefits to regulators as well. It ensures only safe and effective veterinary medicines reach the market, protecting both animal health and public health, thereby preventing zoonotic diseases. It ensures medicines are manufactured to high standards reducing the risk of substandard or counterfeit products. The economic benefits that flow from a functioning regulatory framework, such as improved market access, increased investment and trade facilitation, are compounded at national level contributing to rural economies and GDP. Regulators also have a stake in improved disease control; effective regulation ensures timely availability of veterinary medicines for the prevention and control of animal diseases directly contributing to countries’ disease control efforts.  

Ultimately, facing evolving disease threats because of climate change and global trade, the animal health private sector and livestock producers need a greater say in the development of Africa’s regulatory system in order to deliver much-needed improvements to its efficiency. Improving regulatory frameworks requires regulators, the private sector and livestock producers to come together to develop an accessible and time- and cost-effective regulatory system for veterinary medicines.

GALVmed work

Parties like GALVmed, for example, can be an invaluable convener. GALVmed is already supporting the implementation of the East African Community Mutual Recognition Procedure project, which is helping to harmonize registration requirements for veterinary medicines across eight countries in East Africa. By allowing companies to seek approval for multiple countries simultaneously, rather than bilateral applications at a national level, this project incentivises animal health companies to seek licences in multiple countries, thereby increasing their market.

This creates more choice and support for livestock producers and offers a model for harmonizing regulations for veterinary medicines across the continent, working hand-in-hand with the private animal health sector.

GALVmed is also working in collaboration with WOAH, the Veterinary Medicines Directorate and the East African Community on a new project called Improving Access to Quality Veterinary Products via Better Regulation. This will support regulatory agencies across Africa to identify their capacity-building needs and how they could be addressed, helping to improve the regulation of veterinary medicines at scale.

Ultimately, the inadequate and inefficient regulatory system for veterinary medicines that prevails across most of Africa causes negative impacts throughout the value chain – for regulators, animal health companies, livestock farmers and the continent’s food security at large. The momentum from past and current efforts by various parties must be accelerated. Well-functioning regulatory frameworks will lead to increased investment, confidence in the system, resulting in availability of more safe and effective veterinary medicines in the market. 

Achieving this goal will help ensure Africa’s livestock producers have quality veterinary medicines that address the rising disease challenges they face while safeguarding their contribution to the future of food security in Africa.

Creating an enabling environment for the regulation of veterinary medicines in Africa

In sub-Saharan Africa, bringing safe and high-quality veterinary products and vaccines to market often involves navigating complex, time-consuming, and resource-intensive regulatory processes.

This challenging process presents a significant barrier to private sector investment and undermines the sustainable supply of high-quality, safe, and effective livestock health products. This situation adversely affects regulators, product manufacturers, and ultimately, small-scale producers by limiting their access to high-quality veterinary products that are essential for the care and treatment of their livestock. This in return compromises food security and safety, diminishes animal health and productivity, and impacts farmers’ livelihoods.

An improved policy and regulatory environment that facilitates the successful transformation of research products into sustainable animal health solutions for small-scale livestock producers is crucial to achieving GALVmed’s mission and ensure availability of safe and efficacious veterinary products in sub-Saharan Africa.

Since 2011, the East African Community (EAC) with support from GALVmed, and HealthforAnimals have been implementing the EAC’s Mutual Recognition Procedure system (EAC MRP), which simplifies the registration process by allowing applicants to apply simultaneously for licences in multiple countries. Now, a new project to be implemented in collaboration with the World Organisation for Animal Health (WOAH), the EAC, and the UK Veterinary Medicines Directorate  (UK-VMD), and with funding from the Bill & Melinda Gates Foundation (BMGF), is set to further improve the regulatory systems in sub-Saharan Africa.

The Challenges of Veterinary Medicines Regulation in Africa

The Better Regulation Project Vision

GALVmed & Partners

The Better Regulation project will support the establishment of a long-term governance structure for cooperation between veterinary regulatory agencies. It will further develop and promote the adoption of a self-assessment tool to help regulators strengthen their capacities. Additionally, the project will improve the efficiency and sustainability of the EAC MRP. All these activities are expected to create a more effective regulatory environment for veterinary medicines.

Improving the regulatory systems for veterinary medicines across Africa will ensure that quality, safe, and effective veterinary products are available on the continent in a timely manner. This will contribute to improved animal health, livestock production, and livelihoods.

From lab to field: an enabling environment ensures innovation reaches farmers

Written by Lois Muraguri, Senior Director of Enabling Environment & Partner Engagement.

After fifteen years of improving livestock health in sub-Saharan Africa and South Asia, we at GALVmed know the huge impact that new animal health products can have for small-scale livestock farmers, their households, communities and countries. Innovations such as GALVmed’s highly effective Newcastle disease vaccines have unlocked life-changing economic benefits for farmers, enabling them to expand their businesses, improve household nutrition, cover medical bills and send their children to school.

However, we also know that product development is only the first step in improving livestock health in the world’s lower and middle-income countries. By itself, research and development cannot put new animal health technologies in the hands of farmers. For that to happen, there needs to be an enabling policy and regulatory environment that encourages animal health companies to register, distribute and sell their products in new countries.

Poor policy prevents investment

Unfortunately, navigating national policies and regulations around animal livestock is a complex and time-consuming ordeal for many organisations. A recent GALVmed survey of major animal health companies confirmed what we already knew anecdotally: businesses trying to invest in sub-Saharan Africa and South Asia face significant policy challenges. These include inefficient systems for registering veterinary products, monitoring products in the market, prohibitive taxes or duties on imports and unclear policies on the roles of public and private service providers.

Coupled with the lack of market data and associated risks of investing in lower and middle-income countries, these hurdles are enough to dissuade many companies from selling their products in sub-Saharan Africa and South Asia. As a result, the private sector misses out on the largely untapped market of small-scale livestock farmers, governments miss out on effective business partners, and most importantly, farmers miss out on incredibly valuable livestock vaccines, therapeutics and other animal health products.

GALVmed is determined to change this.

Creating prosperous, sustainable markets

This is why GALVmed works across the entire livestock value chain – from laboratory to field – to ensure that small-scale livestock farmers can access products best suited to their needs. We collaborate with global organisations, such as the World Organisation for Animal Health, that are charged with developing veterinary standards for use in countries. We support national regulators to establish clear, coherent policies. And we leverage our convening power to promote productive collaboration between the public and private sectors, encouraging better use of resources to create prosperous and sustainable markets.

Since 2011, for example, GALVmed has supported the East African Community to implement the Mutual Recognition Procedure (MRP) project. This registration system has not only harmonised the technical requirements for registration of vaccines and pharmaceuticals, but has simplified the process by allowing applicants to apply for licences for animal health products in multiple countries simultaneously. By saving time and resources for both the public and private sectors, MRP supports the sustainable supply of quality registered veterinary medicines in East Africa. Since its creation, there has been an increase not only in the number of applications for products in the region, but in the number of companies – African and global – submitting applications.

More recently, GALVmed was instrumental in establishing the Veterinary Inputs Suppliers Association of Kenya (VISAK). Established in 2018 and formally recognised the following year, VISAK is a rapidly growing association of companies involved in the manufacture, import and distribution of animal health products and equipment in Kenya. In just a few years VISAK has come to be seen as a trusted intermediary between regulators and the private sector and a catalyst for local manufacturers.

GALVmed’s efforts to create an enabling environment for sustainable adoption of animal health inputs by small-scale livestock farmers are just as important as our contributions to product development. Only when research and development is paired with clear and effective policies and regulatory systems can innovative animal health products reach farmers. By enabling farmers across sub-Saharan Africa and South Asia to choose from a growing range of quality registered products, GALVmed is working with its partners to improve livestock health, boost business, support governments and strengthen farmer livelihoods.

East African Community Mutual Recognition Procedure: What is it and why is it important?

Obtaining approval to sell veterinary medicines in the market requires a marketing authorisation (licence) from the National Regulatory Authority in each country where the product is to be sold. In East Africa, this involves applying for a marketing authorisation separately in each country. This is often lengthy, resource-intensive, and unpredictable.

Since 2011, the East African Community (EAC) with support from GALVmed, AU-PANVAC (Pan African Veterinary Vaccine Centre of African Union) and HealthforAnimals (the global animal health industry association) has been implementing the EAC’s Mutual Recognition Procedure (MRP) system which allows applicants to apply simultaneously for licences in multiple countries. This saves time and allows countries and applicants to use their resources more efficiently. MRP increases the likelihood for the sustainable supply of quality registered veterinary medicines in the region.

The first licence under MRP was issued for a veterinary vaccine in October 2018. Since then, several applications, immunological and pharmaceutical, have been processed and are now authorised in multiple countries in the EAC. This has contributed to increased access to quality safe, efficacious veterinary medicines.

Numerous benefits

Apart from saving time and resources in the submission process, MRP has other benefits. For the National Regulatory Authorities (NRAs), some of the benefits include:

  • Increased efficiencies by avoiding duplication of effort
  • Increased likelihood of improved quality of dossier submitted
  • The approach builds trust between assessors and Good Manufacturing Practice (GMP) inspectors
  • Identical dossier is submitted to all   participating NRAs
  • Approved veterinary medicines have the same finished product specification and SPC across the region
  • For inexperienced and less resourced NRAs, have an opportunity to learn and benefit from the more experienced and resourced NRAs 

And benefits to the industry include:

  • One dossier format to all NRAs
  • One procedure with one set of questions agreed on by the Reference Country ant the Concerned Country/Countries and based on a specific time-line – a predictable process that enhances planning 
  • Harmonised release criteria
  • Harmonised label claims
  • Possibility of fewer field trials
  • Harmonised post marketing activities – variations and renewal times harmonised and granted/approved at the same time and hence rapid introduction of new veterinary medicines in the market

All these benefits translate to increased likelihood of sustainable supply of quality registered veterinary medicines to livestock producers in the region.

Current progress

Since being introduced, the MRP process has received submissions from seven (7) global and African companies. Several applications for immunological and pharmaceutical products have been processed and authorised in multiple countries in the EAC, and approval time has been reduced significantly to about 12 months.

The MRP initiative is set to expand to include veterinary pesticides and subsequently, veterinary medical devices. The goal of improving access to quality veterinary medicines in EAC region with limited regulatory capacity could be addressed through regulatory reliance.

Blog written by Adelaide Ayoyi