Biologics Working Party

The Biologics Working Party (BWP) is a working party of the Committee for Medicinal Products for Human Use (CHMP). The BWP provides recommendations to the European Medicines Agency's (EMA) scientific committees on all matters related to the quality aspects of medicines with biological or biotechnological active substances.

Also on this topic

• Biologics Working Party documents

Role

The responsibilities of the Biologics Working Party include:

• Supporting the CHMP, the Committee for Advanced Therapies (CAT) and the Scientific Advice Working Party (SAWP) on quality issues for ongoing procedures involving biological substances;
• Preparing scientific guidance;
• Engaging with internal stakeholders, international partners, industry stakeholders, and academia;
• Training assessors of the European medicines regulatory network to build its capacity.

BWP is supported by the operational expert groups on vaccine quality (BV OEG) and plasma master files (PMF OEG).

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

3-year work plan for the Biologics Working Party (BWP) 2025-2027

Reference Number: EMA/184789/2024

Composition

The BWP is composed of European experts.

CHMP nominates members to this working party on the basis of their expertise and regulatory experience on the subjects covered within the working party scope.

The European Directorate for the Quality of Medicines and Healthcare (EDQM) and Swissmedic may also nominate observers to participate in the work of BWP.

Members

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

• Greger Abrahamsen
• Lyudmil Antonov
• Anna Katalin Barane Gilicze
• Andreea Barbu (Vice-Chair)
• Sean Barry (Chair)
• John Joseph Borg
• Vitalis Briedis
• Koenraad Brusselmans
• Katrin Buss
• Angelo Ferreira da Silva
• Pablo de Felipe
• Dijana Derganc
• Helerin Eiche
• Niklas Ekman
• Sarah Gilgunn
• Elena Grabski
• Sonia Klinger
• Barbora Ladinova
• Sandra Lopes
• Christian Mayer
• Ulrike Muus
• Matthias Renner
• C. Susana Rojo
• Simona Russo
• Petra Schlick
• Magdalena Szymaniak
• Mirela Tavakol
• Panagiota Tsantili
• Marja van de Bovenkamp
• Roeland Martijn Van der Plas
• Suzana Vidic
• Mats Welin