EMA

The Committee for Medicinal Products for Veterinary Use (CVMP) has updated the current guidelines on veterinary medicines for minor uses and minor species (MUMS). These revised guidelines provide more clarity on data requirements and include three guidelines explaining which data are required to demonstrate quality, safety and efficacy. The fourth revision concerns specific considerations for immunological veterinary medicines for MUMS. The guidelines point out in which cases data requirements can be reduced. Furthermore, they facilitate the determination of studies that are required for obtaining marketing authorization. This should stimulate the development of veterinary medicines and immunological products for MUMS, eventually leading to an improvement of animal health care.

More information can be found here.

Share This