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:
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.
United Kingdom’s (UK) withdrawal from the EU
EMA has published important information to help users of the centralised procedure prepare for the expected consequences of 'Brexit', including their obligations related to establishment within the European Economic Area (EEA). For more information, see UK’s withdrawal from the EU.
Some regulatory topics span the product lifecyle. The entry pages on these topics provide an overview of the topic and direct users to relevent content in the product lifecycle sections.
- Accelerated assessment
- Adaptive pathways
- Advanced therapies
- Ancillary medicinal substances in medical devices
- Antimicrobial resistance
- Biosimilar medicines
- Clinical data publication
- Clinical trials
- Compassionate use
- Conditional marketing authorisation
- Data submission (Article 57)
- Ethical use of animals in medicine testing
- Falsified medicines: overview
- Generic and hybrid application
- Herbal products
- Innovation in medicines
- Medicines for older people
- Marketing authorisation application
- Medicine shortages
- Medicines for use outside EU (Article 58)
- Orphan designation
- Paediatric medicines
- Parallel distribution
- Pharmacovigilance fees
- Plasma master file (PMF) certification
- Pre-authorisation guidance
- Post-authorisation guidance