ATMP - Monthly Report of the CAT January 2016

On 21 and 22 January, the Committee for Advanced Therapies (CAT) held its 78th CAT meeting. In his monthly report, they published relevant data about application procedures, guidelines and related documents on ATMP.

The last reports included following bullet points:

Scientific recommendation on advanced therapy product classification - Further to consultation with the European Commission, the CAT finalised eighteen scientific recommendations on the classification of advanced therapy medicinal products. This means the classification as gene therapy-, cell therapy- or tissue engineered medicinal products or as non-ATMP. (More details about ATMP Classification)

CAT adopted its work plan for 2016 - Highlights from the work plan are the development of guidance documents; contribution to cross-committee projects; work on simplification of procedures and requirement for ATMPs and the organisation of an ATMP assessor training and a scientific workshop on cell-based cancer immunotherapy products.

Organisational matters - CAT discussed with colleagues from the European Commission, DG Research ATMP-related research priorities that could be considered in future calls funded by Horizon 2020 and reflected on the interactions between them and the scientific advice working party and how to improve the current process of providing CAT input on scientific advice requests for ATMPs.  

Overview of product-related activities - the report includes data about the ongoing evaluatio procedures for ATMP, following as example the data for scientific advice

Scientific Advice Procedures for ATMPs

2009 2010 2011 2012 2013 2014 2015 2016 Total
Discussed* 25 30 36 31 36 48 63 1 270
Number of procedures 17 19 21 19 23 33 39 7

* Most scientific advices for ATMPs are discussed by the CAT at 2 time points during the SA procedure

Further statistical data can be found directly in the CAT monthly report of application procedures, guidelines and related documents on advanced therapies.

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