European Medicines Agency recommends 14 medicines for use in animals in first half of 2014

News 16/07/2014

Fourteen new veterinary medicines were recommended for marketing authorisation by the European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) in the first half of 2014. This figure exceeds the total number of medicines recommended for marketing authorisation during the whole of the previous year (12). This increase is partly due to the record number of initial marketing-authorisation applications submitted in 2013 that have now come to the stage of opinion during 2014, and partly due to the authorisation of a related range of vaccines for dogs.

The CVMP started the evaluation of marketing-authorisation applications for 7 new medicines, with similar numbers of pharmaceuticals and immunologicals. Four of these medicines are intended for food-producing animals, including 2 products developed by means of a biotechnological process.

The trend observed in 2013 with an increase of initial applications to establish a maximum residue limit (MRL) seems to continue, with 3 new MRL applications received, indicating increased interest from the animal health industry in developing new products for food-producing animals. In the European Union, an MRL determines the maximum acceptable concentration of residue in a food product obtained from an animal that has received a medicine.

So far this year, the CVMP has received 11 requests for scientific advice and the committee has responded to 17, continuing work at an increased pace after a record number of submissions (40) were received in 2013.

The CVMP has also recommended the classification of 8 veterinary products as intended for minor use, minor species (MUMS)/limited markets, one of which also qualified for financial incentives. Since its introduction in October 2010, the MUMS/limited market policy has been highly successful in terms of stimulating the development of new veterinary medicines for minor species and for rare diseases in major species.

It is particularly encouraging that 2 products classified by the CVMP as intended for MUMS/limited markets were recommended for marketing authorisation in the first half of 2014 and a further product is now under evaluation.

The MUMS/limited market policy has been undergoing a review which is now nearing completion. A first outcome of this ongoing review has been to restrict financial incentives to products intended for MUMS/limited markets that are indicated for food-producing animals, on the basis that this category of products most requires and warrants financial support. The slightly fewer applications considered eligible for financial incentives so far in 2014 compared with previous years is likely to result from this policy amendment, which came into effect last year.

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