Biologics Working Party

The Biologics Working Party (BWP) provides recommendations to the European Medicines Agency's scientific committees on all matters relating directly or indirectly to quality and safety aspects relating to biological and biotechnological medicines.

Also on this topic

• Biologics Working Party documents

Role

The BWP's tasks include:

• providing support to the Committee for Medicinal Products for Human Use (CHMP) on dossier evaluation, to facilitate consistency of assessments and the coherence of CHMP opinions;
• acting as coordinators of plasma-master-file (PMF) dossiers and providing recommendations on PMF certification to the CHMP, these recommendations are based on the scientific and technical assessments of the working party’s PMF group;
• at the request of the CHMP, providing scientific advice on general and product-specific matters relating to the quality aspects of biological and biotechnological medicinal products;
• preparing, reviewing and updating guidelines, in conjunction with other appropriate working parties;
• liaising with interested parties, such as pharmaceutical industry associations, learned societies, healthcare-professional organisations and patient organisations;
• international cooperation on the quality and safety of biological and biotechnological medicinal products;
• contributing to CHMP scientific opinions in collaboration with the World Health Organization (WHO) for the evaluation of medicines intended for markets outside the European Union (EU);
• acting as a focus and catalyst for training;
• contributing to and organising workshops and training sessions on the quality and safety of biological and biotechnological medicinal products;
• interacting with the European Directorate for the Quality of Medicines and Healthcare (EDQM), particularly in relation to European Pharmacopoeia activities, biological standardisation and the activities of the Official Medicines Control Laboratory (OMCL) network;
• preparing statements on general or product-specific matters for the public;
• on request of the CHMP, constituting a rapid-acting crisis group to take on specific issues relating to the quality of biological or biotechnological medicinal products, including quality in relationship to safety aspects, 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

EMA will provide information on the mandate, responsibilities and procedures once available.

This working party's work plan is available below:

3-year work plan for the Biologics Working Party (BWP) 2024-2026

Reference Number: EMA/3681/2024

Composition

The BWP is composed of European experts selected according to their specific expertise.

All members of the CHMP are invited to nominate one expert to be a member of the BWP (one member per Member State) on the basis of their specific expertise or regulatory experience on the subjects covered within the scope of the BWP mandate.

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