Cell-based Products Working Party

The Committee for Advanced Therapies (CAT) has established a temporary working party on cell-based therapy, following the discontinuation of the existing Cell-based Products Working Party of the Committee for Medicinal Products for Human Use (CHMP).

The Cell-based Products Working Party (CPWP) is a multidisciplinary group of European experts that provides recommendations to the CAT on all matters relating directly or indirectly to cell-based therapy, including somatic cell therapy medicinal products and tissue engineered products. Their work includes:

• preparing, reviewing and updating guidelines and other guidance documents, such as reflection papers, in conjunction with other working parties as appropriate;
• ensuring that the scientific committees and working parties are informed about the scientific issues specific to cell therapy medicinal products;
• providing scientific reports on matters of public interest and emergency issues pertaining to cell-based therapy.

At the request of CAT, the CPWP can also:

• contribute to scientific advice procedures, marketing authorisation evaluation, post-authorisation procedure evaluation, certification, paediatric investigation plan evaluation and orphan designation related to cell-based products;
• contribute to briefing meetings related to cell-based therapies with external parties, such as pharmaceutical companies, academia, public-private partnerships and patient associations, often in collaboration with the Innovation Task Force;
• liaise with interested parties, such as learned societies, trade organisations, industry, academia and patient organisations;
• contribute towards international co-operation on matters related to cell-based products;
• act as a focus and catalyst for training for the quality, preclinical and clinical assessment of cell-based products;
• contribute to and organise workshops and training courses on cell-based products;
• constitute a rapid-acting crisis group to take on specific issues related to cell-based products with the objective of exchanging information on a European level and co-ordinating responses to the public in a timely manner.

Mandate, rules of procedure and work programme

More information on the CPWP's responsibilities and composition are available in these documents:

• Mandate, objectives and rules of procedure
• Work plan

Composition

Up to 10 European experts constitute the core group of the CPWP. These experts are identified and nominated by the CAT on the basis of their specific scientific expertise or regulatory experience on the subjects covered within the scope of the working party’s mandate. The core group includes one representative from the Biologics Working Party (BWP), one from the Safety Working Party (SWP), and one from the CAT, all of whom have experience in cell-based therapy.

The members of the CAT ensure that information on the activities of the CPWP is disseminated at a national level.

Members

Below (in alphabetical order of surname) are the current members of the CPWP. The members' declarations of interests are available in the European expert list.