The pharmacovigilance system in the European Union (EU) operates with the management and involvement of regulatory authorities in Member States, the European Commission and the European Medicines Agency. In some Member States, regional centres are in place under the coordination of the national competent authority.
Within this system, the Agency's role is to coordinate the EU pharmacovigilance system and to ensure the provision of advice for the safe and effective use of medicines.
- 2010 pharmacovigilance legislation
- Electronic submission of information on medicines
- Good pharmacovigilance practices
- Risk-management plans
- Signal management
- List of medicines under additional monitoring
- Union reference dates and submission of periodic safety update reports
- European Risk Management Strategy
- Funding for medicine safety studies: European Commission Seventh Framework Programme
- Regulatory and procedural guidance