Fifteenth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines EMA is hosting the fifteenth industry stakeholder platform on …

The medicine you are looking for may be authorised in individual Member States via national procedures, rather than centrally via EMA. Only medicines evaluated by EMA are available on …

Information on the regulation of medicines for human use in the European Union (EU), with a focus on the centralised procedure. The European Medicines Agency (EMA) plays a key role …

While the majority of new, innovative medicines are evaluated by EMA and authorised by the European Commission in order to be marketed in the EU, most generic medicines and …

The European Medicines Agency (EMA) is responsible for the scientific evaluation of centralised marketing authorisation applications (MAA). Once granted by the European Commission, the …

EMA strongly encourages applicants and marketing authorisation holders to follow the guidelines featured on this page. Applicants need to justify deviations from guidelines fully in their …

Check EMA's annual reports for insights into our regulatory procedures, activities, and achievements. The reports include an interactive timeline and figures and statistics for easy …

Jan 16, 2025 · In 2024, EMA recommended 114 medicines for marketing authorisation. Of these, 46 had a new active substance which had never been authorised in the European Union (EU) …

The European Medicines Agency (EMA) provides scientific and regulatory guidance to pharmaceutical companies whose medicinal products have been authorised in Europe.

This complements information on medicines published on this website, which only includes medicines that the European Medicines Agency (EMA) evaluates. Some of these registers …