EMA Streamlines Working Parties - - BioPharm International

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EMA Streamlines Working Parties



The European Medicines Agency (EMA) has abolished its Cell-based Product Working Party (CPWP) and Gene Therapy Working Party (GTWP), with the aim of improving efficiencies and optimizing the use of available expertise.

Instead, EMA’s Committee for Advanced Therapies (CAT) will be assuming the lead role in all aspects concerning the development of advanced-therapy medicines in Europe, including developing guidelines, organizing workshops and establishing ad-hoc draft groups as and when required to develop specific guidance documents. Guidance documents already being developed by CPWP or GTWP will be taken over by the new drafting groups.

According to a statement from EMA, the move will strengthen the role of CAT as Europe’s reference body for advanced-therapy medicines. The Agency also thanked the members of CPWP and GTWP for their work over the past few years.

When establishing draft groups, approximately five experts will be drawn from CAT’s members and the European expert list. However, the current members of CPWP and GTWP will remain on consultation list for whenever their expertise is required.

CPWP and GTWP both existed prior to the establishment of CAT in 2009 and originally belonged to EMA’s Committee for Medicinal Products for Human Use. The parties were transferred once CAT initiated operational activities.

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