Committee for Advanced Therapies' activities streamlined
The European Medicines Agency has replaced the activities of the two working parties of the Committee for Advanced Therapies (CAT) - the Cell-based Products Working Party (CPWP) and Gene Therapy Working Party (GTWP) - with ad-hoc drafting groups. This is part of a drive to improve the efficiency of the Agency's operations and optimise the use of the expertise available.
From now on, the CAT will take the lead responsibility for the development of guidelines and organisation of workshops, setting up drafting groups whenever needed to develop specific guidance documents. This is intended to strengthen the role of the CAT as the reference body dealing with all aspects of the development of advanced-therapy medicines in Europe.
The drafting groups will include around five experts drawn from the CAT's members and the European expert list. The current members of the CPWP and GTWP will remain on this list for consultation whenever their expertise is required.
Guidance documents already under development by the CPWP or GTWP will be taken over by ad-hoc drafting groups.
The Agency and the CAT thank the members of the two working parties for their excellent work over the past few years.
The CPWP and GTWP both existed prior to the establishment of the CAT in 2009, when they belonged to the Committee for Medicinal Products for Human Use (CHMP). The working parties were transferred once the CAT had started its operational activities.