Ten years of MUMS: 22 new veterinary medicines authorised for minor uses and minor species
In the last ten years, 22 new veterinary medicines for minor uses and minor species (MUMS) have been authorised through the centralised procedure by EMA. This is largely the result of the MUMS/limited market policy for the classification of veterinary medicines established by the Agency in 2009.
EMA has published a report looking at the main achievements of the policy over the last ten years . The report was adopted by EMA’s Management Board at its March 2020 meeting.
In total, EMA’s veterinary medicines committee (CVMP) reviewed 272 requests for classification as MUMS/limited market from 2009 to 2019. Out of the 272 requests, 245 were classified as MUMS and of these, 73 products were also recommended as eligible for financial incentives.
Approximately one third of the requests were submitted by companies registered as micro, small or medium-sized enterprises (SMEs) at EMA.
The MUMS/limited market policy is a joint activity between EMA and the European medicines regulatory network. It was established to stimulate the development of new veterinary medicines for minor species and for rare diseases in major species that would otherwise not be researched in the current market conditions. The incentives provided by the policy include reduced data requirements and fee exemptions or reductions.
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 in limited geographical areas only. Minor species are all animals that are not one of the major species. The policy also applies to veterinary medicine for which there is only a limited market e.g. vaccines against certain cancers in animals, vaccines for fish or medicines to treat diseases in bees.
The new Veterinary Medicines Regulation (EU) 2019/6, which entered into force in January 2019 and will become applicable in January 2022, will introduce specific provisions in the EU legislation to boost the development of new medicines for limited markets, building on the success of EMA’s experience applying the MUMS/limited market policy over the last ten years.