RSS European Medicines Agency (EMA) | Scientific guidelines (human and veterinary)

The European Medicines Agency (EMA) provides scientific guidelines for both human and veterinary medicines. These guidelines are prepared by the Committee for Medicinal Products for Human Use and the Committee for Medicinal Products for Veterinary Use, in consultation with regulatory authorities in the EU Member States. The guidelines help applicants prepare marketing authorisation applications by interpreting and applying the requirements for demonstrating quality, safety, and efficacy as set out in the Community directives. The guidelines are complementary to European Pharmacopoeia monographs and chapters. The EMA strongly encourages applicants and marketing authorisation holders to follow these guidelines, and any deviations must be fully justified in their applications. The guidelines are organized into various categories such as quality, safety, efficacy, and immunologicals for veterinary medicines, and similar categories for human medicines. The guidelines are updated and replaced periodically to reflect the latest scientific and regulatory developments.