Efficacy Working Party (EWP)

Efficacy Working Party no longer functional

The Efficacy Working Party ceased its work in September 2010 after many years of successful work. Because the complexity of the system and the working party's workload had increased considerably, it was replaced by a number of temporary working parties with narrower fields of expertise.

For more information:

The Efficacy Working Party (EWP) provided recommendations to the Committee for Medicinal Products for Human Use (CHMP) on all matters relating directly or indirectly to the clinical part of drug development.

The EWP's tasks included:

  • preparing, reviewing and updating guidelines in specific therapeutic areas and on methodology and interpretation of clinical trials;
  • supporting dossier evaluation;
  • providing advice to the CHMP on general and product-specific matters relating to the clinical part of drug development;
  • liaising with interested parties;
  • international cooperation with regulatory agencies, the Food and Drug Administration (FDA) and the World Health Organization (WHO);
  • providing advice, through the CHMP, to the European Commission and the Coordination Group for Mutual-Recognition and Decentralised Procedures-Human (CMD(h)) on clinical-development-related issues;
  • providing training on clinical assessment in various therapeutic fields

Mandate, rules of procedure and work programme

Further details of the Efficacy Working Party's responsibilities, composition etc. are available in the following documents:

Composition

The EWP was composed of one expert per Member State, selected from the European experts list and nominated by members of the CHMP. Additional experts and observers could also be invited to participate in the work of the EWP.

Members

Below (in alphabetical order of surname) are the names of the members of the Efficacy Working Party:

Members