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Regulatory News | 27 January 2015 | By Michael Mezher
The European Medicines Agency (EMA) recommended 20 new veterinary medicines for approval in 2014, the highest number in the past five years, according to data provided by the regulator. The agency also boasts that it received 29 requests for classification of medicines intended for rare diseases or species with a small population, the most the agency has seen in a single year.
In 2009, EMA’s Committee for Medicinal Products for Veterinary Use (CVMP) introduced a new classification for veterinary products termed “minor use minor species (MUMS)/limited market,” to address the lack of development of veterinary products for rare veterinary diseases or products that target minor species.
The MUMS/limited market classification in some ways parallels orphan product designation for human medicines as it is meant encourage the development of products for smaller patient populations through certain incentives. Products applying for MUMS/limited market classification are subject to reduced data requirements, which can make the drug development process less costly. Additionally, products indicated for use in food-producing animals are eligible for reduced fees.
EMA is currently accepting comments on a consultation paper regarding the data requirements for MUMS products. The agency seeks to review the current guidelines for data requirements in light of the experience the agency and other stakeholders have gained since the classification was introduced.
Among EMA's 20 new veterinary medicine approvals are two new vaccine products.
In 2014, EMA recommended the first vaccine against Schmallenberg virus for approval. Schmallenberg virus was first reported in 2011 and has quickly spread to cattle and sheep populations in multiple EU countries and “can cause a drop in milk production in adult animals and attacks the brain and spinal cord of developing fetuses.”
EMA also recommended the first marker vaccine to immunize pigs against classical swine fever virus in pigs in 2014. Marker vaccines create antibodies that are distinguishable from the antibodies that would be produced in response to infection from the wild virus. The ability to distinguish between animals that are immunized from ones that are naturally infected could reduce the need for mass eradication during outbreaks.
EMA Press Release
Tags: Veterinary Medicines, MUMS, Minor Use Minor Species, CVMP, vaccines