Committee for Veterinary Medicinal Products - focus on reducing the risk of antimicrobial resistance and strengthening quality assurance

15 February 2013

The Committee for Medicinal Products for Veterinary Use (CVMP) of the European Medicines Agency will focus its activities this year on reducing the risk of antimicrobial resistance, strengthening the quality-assurance system of opinions and assessment reports and promoting the authorisation of innovative treatments for animals.

The CVMP is responsible for preparing the Agency's opinions on all questions concerning veterinary medicines. These activities include scientific advice for the development of products, the initial assessment of veterinary medicines for which a European Union (EU)-wide marketing authorisation is sought, arbitration in cases where there is a disagreement between Member States or where the interests of the Union are at stake, and scientific opinions where expert scientific input is sought on issues related to veterinary medicines. Another core activity of the CVMP is the establishment of the maximum residue limits (MRLs) of veterinary medicines permissible in food produced by, or from, animals for human consumption, including, meat, milk, eggs and honey.

In 2012, the Committee issued four positive opinions for new vaccines and five for new pharmaceuticals. The Agency received 12 applications for the initial evaluation of new veterinary products in 2012 and approximately 14 applications are expected in 2013.

Interestingly, while in the past the numbers of applications for vaccines and pharmaceuticals were similar, with approximately half of the products intended for food-producing species, in 2012, 83% of applications concerned pharmaceuticals, of which 90% were for companion animals. These products are often adaptations of human medicines or new fixed-dose combinations. A large proportion (75%) of the products for companion animals was for the treatment or prevention of parasites. In total, only 25% of applications were for food-producing animals.

With 136 products now authorised through the centralised procedure, post-authorisation applications and pharmacovigilance procedures are constantly increasing.

The number of requests for scientific advice remains at a constant, slightly increased level in 2012 with 28 requests received, indicating a continuing interest by the animal-health industry in developing new products.

Antimicrobial resistance

Nine of the 12 referrals received in 2012 concerned products containing antimicrobial substances for food-producing animals. This reflects the high level of concern within the EU to ensure that such products are authorised with appropriate conditions of use in order to reduce the risk of antimicrobial resistance development as much as possible.

In 2013, the CVMP — with the support of its Antimicrobials Working Party and in line with its CVMP strategy on antimicrobials 2011-2015 — will strengthen its contribution to the priority area of minimising the risk of development of antimicrobial resistance arising from the use of antibiotics in animals both within the EU and at an international level.

“Despite increasing awareness, antibiotics are still over-used in certain situations in both the human and the veterinary worlds. The use of antibiotics needs to be brought under better control so that treatment options for coming generations are not compromised,” explains Anja Holm, Chair of the CVMP.

In this area, reliable data on patterns of sale of veterinary antimicrobials over time and across the EU are important to underpin fact-based policy-making with respect to managing the risk of antimicrobial resistance at EU level. The CVMP will continue to benefit from the findings of the European Surveillance of Veterinary Antimicrobials Consumption (ESVAC) project, which is being developed from a pilot into an operational system in 2013.

Two reflection papers related to the use of antimicrobials and the emergence of resistance are currently open for public consultation: one on the use of pleuromutilins in food-producing animals, and one on developing new methodologies for the ESVAC project.

Quality of assessment

The Agency and its CVMP will continue to strengthen the quality-assurance system for CVMP procedures, to ensure the quality and consistency of scientific assessment reports. Particular emphasis will be placed on embedding benefit-risk analysis into assessment methodology, with the goal of ensuring that the CVMP provides clear grounds for its opinions to applicants, the European Commission and the public.

Support to innovation

The CVMP places great importance on providing support to applicants seeking authorisation of innovative medicines. In addition to the assistance provided by the Agency to micro, small and medium-sized enterprises (SMEs), applicants can benefit from scientific advice from the CVMP and pre-submission meetings with the Agency's staff and the Committee's rapporteurs. For the first time in 2013, veterinary medicinal products will be included in the Agency's Innovation Task Force. In addition, the CVMP will provide advice to the European Commission on how best to accommodate novel therapies as part of the review of veterinary legislation.