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

The BWP's work plan is available below: