The pharmacovigilance system in the European Union (EU) operates between the 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.
The Agency's role is to coordinate the EU pharmacovigilance system and to operate specific systems, services and processes as laid down in the EU legislation.
The EMA pharmacovigilance system is described in the EMA pharmacovigilance system manual.
Pharmacovigilance in the product lifecycle
|Research and development||Marketing authorisation||Post-authorisation|
|Good pharmacovigilance practices (GVP)|
|Incident management plan|
|Medicines under additional monitoring|
|Periodic safety update reports|
|Post-authorisation safety studies|
|Regulatory and procedural guidance|
How useful is this page?
Average rating:Based on 185 ratings
Add your rating:
- See all ratings
47 ratings11 ratings16 ratings38 ratings73 ratings
- European Medicines Agency pharmacovigilance system manual (2016-10-14)
- Pharmacovigilance (2015-05-18)