Human medicines: regulatory information

This section of the website provides information on the regulation of medicines for human use in the European Union (EU). It particularly concerns the centralised procedure, where the European Medicines Agency (EMA) plays a key role.

The navigation menu contains three main sections corresponding to the key medicinal product lifecycle stages:

• research and development;
• marketing authorisation;
• post-authorisation.

Regulatory information on herbal products is in a separate section, as these products are regulated differently in Europe.

For further information on EU legislation and procedures for the regulation of human medicines, see volumes 1-4 and 9-10 of the rules governing medicinal products in the EU.

Some regulatory topics span the product lifecycle. The entry pages on these topics provide an overview of the topic and direct users to relevant content in the product lifecycle sections.