Regulatory Focus™ > News Articles > EMA's Committee for Advanced Therapies to Assume More Responsibility Under Restructuring

EMA's Committee for Advanced Therapies to Assume More Responsibility Under Restructuring

Posted 25 September 2012 | By Alexander Gaffney, RAC 

Officials at the European Medicines Agency (EMA) have announced the reorganization of two working groups within its Committee for Advanced Therapies (CAT), an advisory committee charged with evaluating advanced-therapy medicinal products (ATMPs).

Under the new changes, both the Cell-based Products Working Party (CPWP) and the Gene Therapy Working Party (GTWP) will be transformed into ad hoc drafting groups, said EMA.

In a statement, EMA explained the move is intended to improve the efficiency with which the agency allocates its subject matter experts and its operational resources. Previously, both the CPWP and GTWP were responsible for drafting and reviewing guidelines-a role that will now be taken over by CAT except when experts are required to draft more specific guidelines.

"This is intended to strengthen the role of the CAT as the reference body dealing with all aspects of the development of ATMPs in Europe," explained EMA.

Another change will be the size of the new ad hoc groups relative to the working parties. CPWP and GTWP both had as many as 10 experts serving on them at any one time. The new groups will have "around five" experts, with others held on a reserve list for consultation as needed.

EMA said any guidelines currently in development will be taken over by the new ad hoc working groups, though it remained unclear which experts-if any-would be removed from the working party in the transition.


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