Quality Working Party

The Quality Working Party (QWP) is a joint working party of the Committee for Medicinal Products for Human Use (CHMP) and the Committee for Medicinal Veterinary Medicinal Products (CVMP). The QWP provides recommendations to the European Medicines Agency's (EMA) scientific committees on all matters related to quality aspects of medicines with chemical active substances

Role

The responsibilities of the Quality Working Party include:

• Supporting the CHMP, CVMP and the Scientific Advice Working Party (SAWP) in responding to quality questions for ongoing procedures involving chemical active substances;
• Preparing scientific guidance for both human and veterinary medicinal products;
• Engaging with internal stakeholders, international partners, industry stakeholders, and academia;
• Training assessors of the European medicines regulatory network to build its capacity.

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 joint CHMP/CVMP Quality Working Party 2025-2027

Reference Number: EMA/188820/2024

Composition

The QWP is composed of European experts.

CHMP or CVMP nominates members to this working party on the basis of their expertise and regulatory experience on the subjects covered within the working party scope. This covers both human and veterinary quality. 

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

Members

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

• Tone Agasøster  
• Fernando Blanco
• Peter Caspers
• Eugenia Cogliandro
• Andrea Cseh-Pálos
• Bart Denayer
• Dorota Distlerova
• Lucija Fasalek
• Gernot Hirn
• Blanka Hirschlerova (chair)
• Christopher Janich
• Tina Visholm Jensen
• Karin Krogars
• Nicholas Lee (vice-chair)
• Jobst Limberg
• Olaf Ludek
• Ivica Malnar
• Maryam Mehmandoust
• Mary O’Grady
• Kristofer Olofsson
• Silvia Perez Lopez
• Piet-Hein Overhaus
• Carmen Purdel
• Annika Ridell
• Marie-Hélène Sabinotto  (vice-chair)
• Laivi Saaremäel  
• Christian Spiteri
• Josef Suchy
• Ivana Tasevska
• Patricia Vera Luque
• Tiago Vistulo De Abreu 
• Anna Zadrozna