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.
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.
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