Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

New approaches and requirements in the registration procedure of MUMS-veterinary medicinal products. A comparison between USA, EU and Switzerland

Dr. med. vet. Flurina Stucki (Abschlußjahr: 2006)

Language: English

In the last few years the problem of lacking availability of ve terinary medicinal products in particular for minor species and for minor uses has increased. The small commercial relevance of this market compared to increasing requirements for quality, efficacy and safety in the registration procedure of veterinary medicinal products and the strict regulations concerning food safety (residue problem) are causing a loss of important veterinary medicines.

For some time in the presented three countries or county bodies, a number of initiatives have been taken headed by involved parties namely authorities, breeding organisations, veterinary pharmaceutical industry and veterinarians to resolve the problem. Efforts like establishment of a cascade-system (ruled off-label use), defining the missing veterinary medicines and extrapolation of MRLs have been made. It is now generally accepted that authorized veterinary medicinal products have to be available to treat minor species or minor uses and a mechanism analogous to human orphan drug policy has been postulated. The definition of minor species and minor uses has been an important first step in all countries to develop the preconditions for such a simplified procedure. As a next step to facilitate the approval for these products, the requirements in the registration procedures have to be reduced and financial incentives are necessary.

In the USA, a program and support from the authority is working since 20 years to bring required drugs for minor species and minor uses on the market. In the EU and in Switzerland efforts to simplify the procedures with legal adaptation of the current law are on the way and will be officially established in near future.

Based on the experience form the successful program in the USA, it is clear that it will be very hard to conduct only the most relevant studies without financial support. If the current efforts in the EU and in Switzerland are successful will be seen in a year or two. In every case a strong cooperation between the involved parties is a necessity.

pages: 44,
Annex: pages: 3