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.

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 has temporarily suspended or scaled back certain activities since 2019 based on EMA’s business continuity plan and during the COVID-19 pandemic.

BWP is set for reorganisation in 2023, as part of EMA's revised operating model for working parties.

The updated mandate, rules of procedure and workplan will be published once available.  

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.

Members

  • Gianina-Nicoleta Andrei
  • Marie-Christine Annequin
  • Lyudmil Antonov
  • Sean Barry (Vice-Chair)
  • John Joseph Borg
  • Vitalis Briedis
  • Angelo Ferreira da Silva
  • Pablo de Felipe
  • Helerin Eiche
  • Niklas Ekman
  • Sarah Gilgunn
  • Elena Grabski
  • Marcel H.N. Hoefnagel
  • Gunn Kisen
  • Marie Louise Vindvad Kristensen
  • Liga Kunrade
  • Barbora Ladinova
  • Sandra Lopes
  • Francesca Luciani
  • Tamara Mandusic Nazor
  • Sonja Matt
  • Catherine Milne
  • Ulrike Muus
  • Pawel Pawlowski
  • Ineta Popena
  • Ilona G. Reischl
  • C. Susana Rojo
  • Sol Ruiz (Chair)
  • Simona Russo
  • Zsuzsanna Sasvari
  • Magdalena Szymaniak
  • Magdalena Szymaniak
  • Mirela Tavakol
  • Sofie Termont
  • Roeland Martijn Van der Plas
  • Maria Vassiliou
  • Suzana Vidic
  • Mats Welin