Safety Working Party
Human
Corporate
Governance
Pharmacovigilance
The Safety Working Party (SWP) provides recommendations to the Committee for Medicinal Products for Human Use (CHMP) on all matters relating directly or indirectly to non-clinical aspects of safety. Its work includes:
- providing support to dossier evaluation;
- assessing non-clinical safety findings;
- providing training on non-clinical safety assessments;
- providing advice, through the CHMP, on non-clinical-safety-related matters to the European Commission, the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMD(h)) and the Committee on Herbal Medicinal Products (HMPC);
- liaising with interested parties;
- contributing to international co-operation.
Mandate, rules of procedure and work programme
More information on the SWP's responsibilities and composition is available in these documents:
| EMA has temporarily suspended or scaled back certain activities since 2019 based on EMA’s business continuity plan. |
Composition
The SWP is composed of one expert per Member State, selected from the list of European experts and nominated by members of the CHMP. Additional experts and observers may also be invited to participate in the work of the SWP.
Members
Below (in alphabetical order of surname) are the current members of the SWP. The members' declarations of interests are available in the European expert list.