Non-clinical Working Party

The Non-clinical Working Party (NcWP) was set up by the Committee for Medicinal Products for Human Use (CHMP) to provide advice and recommendations directly or indirectly related to non-clinical aspects.

Also in this section

• Non-clinical Working Party documents

Role

In 2022, the NcWP took over the tasks of the former CHMP Safety Working Party (SWP) and also those of the former Non-clinical Working Group (NcWG) from the Paediatric Committee (PDCO). 

The NcWP's tasks include:

• providing product-related support when requested by the Scientific Advice Working Party and by EMA Committees such as the CHMP, the PDCO and the Co-ordination group for Mutual recognition and Decentralised procedures - human (CMDh);
• preparing, reviewing and updating guidelines and concept papers;
• European and international co-operation;
• liaising with stakeholders such as pharmaceutical companies and patient and healthcare professional organisations;
• providing training and workshops to assessors.

Mandate, rules of procedure and work programme

Mandate, objectives, and rules of procedure for working parties under the quality, non-clinical, methodology, clinical and veterinary domains

Reference Number: EMA/299541/2025

Consolidated 3-year rolling work plan for the Non-clinical domain 2025-2027

Reference Number: EMA/551442/2024

Composition

The NcWP is composed of European experts nominated by CHMP members, taking into consideration the best available expertise needed to deliver its commitments.

The current members are listed below, in alphabetical order of surname.

Their declarations of interests are available in the European expert list:

• European experts