Revised guidelines to encourage development of veterinary medicines for minor uses and minor species
Guidelines clarify data needed for authorisation of medicines for treatment of minor-use-minor-species/ limited-market
The European Medicines Agency's (EMA) Committee for Medicinal Products for Veterinary Use (CVMP) has adopted a set of revised guidelines that clarify the data needed to support an application for a marketing authorisation for veterinary medicines intended for minor uses and minor species, the so-called MUMS and limited markets.
Revision of the guidelines is part of the CVMP's overall objective to stimulate the development of new veterinary medicines for diseases that occur infrequently or in limited geographical areas in major species and for minor species. These medicines may otherwise not be developed under the current market conditions.
The revised set includes three guidelines laying out the data requirements to demonstrate quality, safety and efficacy for veterinary medicines and a fourth guideline which includes specific considerations for the authorisation of immunological veterinary medicines for MUMS. These four documents support applicants to determine the necessary studies for their application dossier for a marketing authorisation. Therefore the guidelines are expected to enhance the availability of veterinary medicines and immunological products for MUMS and thereby improve animal welfare and health.
Based on its eight years of experience with standards for demonstration of quality, safety and efficacy for MUMS products, the CVMP has reviewed and revised the guidelines to update and provide more clarity on data requirements for applicants. The revised guidelines explain under which circumstances data requirements can be reduced for medicines for MUMS/ limited-market to better steer applicants' work in foreseeing the resources needed to meet the standards.
The guideline on immunological veterinary medicinal products is the last guideline in this series to be adopted by CVMP. The other three revised guidelines for data requirements on quality, safety and efficacy for MUMS products were previously adopted by the CVMP in December 2016.
Minor-use medicines are intended for use in major species (cattle, sheep, pigs, chickens, salmon, cats and dogs) to treat diseases that occur infrequently or occur in limited geographical areas. Minor species are all animals that are not one of the major species. Limited-market for a veterinary medicine is a market that is limited in size (e.g. vaccines against cancer in animals, vaccines for fish and bee medicines). The MUMS/ limited-market scheme represents a joint activity between EMA and the European Medicines Regulatory Network aiming to facilitate the access to market of products indicated for MUMS as part of measures to promote the availability of veterinary medicines.