The European Medicines Agency (EMA) offers training to support stakeholders in meeting their pharmacovigilance obligations when using EudraVigilance. Training is important to ensure that users understand its functionalities and submit high quality data which adhere to standards that allow for adequate monitoring of the safety of medicines and the...

The European Medicines Agency's scientific guidelines on biological medicinal products help medicine developers prepare marketing authorisation applications for human medicines.

The European Medicines Agency's scientific guidelines on specific types of products help medicine developers prepare marketing authorisation applications for human medicines.

The European Medicines Agency (EMA) provides guidance and support to companies researching and developing veterinary medicines. This includes scientific and regulatory information on how to design and run clinical trials, compliance standards, how to establish maximum residue limits for medicines and biocides, support to innovation, and support the...

The European Medicines Agency (EMA) is involved in monitoring and evaluating the risks of using antibiotics in animals. It has looked in particular at the risk of the development of antimicrobial resistance in animals and of the possible transmission of resistance to humans.