Committee for Advanced Therapies issues first recommendation for certification of non-clinical data for an advanced therapy

News 26/09/2013

The European Medicines Agency's Committee for Advanced Therapies (CAT) recommended issuing the first certification of non-clinical data for an advanced-therapy medicinal product (ATMP) at its September meeting. The therapy consists of autologous skeletal-muscle-derived cells and is intended to treat female stress urinary incontinence. It has previously been classified by the CAT as a tissue-engineered product.

Micro, small and medium-sized enterprises (SMEs) can request that the CAT assess quality data and, when available, non-clinical data that they have generated at any stage of the ATMP development process. After the assessment, the CAT may recommend issuing a certification confirming the extent to which the available data comply with the standards that apply for evaluating a marketing-authorisation application. Further to the CAT recommendation, the Agency issues a certification.

This CAT opinion concerns the third application for certification so far received by the CAT, and is the first to contain non-clinical as well as quality data. As part of this procedure, the CAT reviews each non-clinical study (such as toxicology, carcinogenicity and pharmacology studies) and provides feedback in terms of medicine development.

The certification procedure is an opportunity for SMEs to get an assessment of the data they have generated and check that they are on the right track for successful development. The aim is to identify any potential issues early on so that these can be addressed prior to the submission of an marketing-authorisation application. The scientific advice procedure, involving experts of the CAT and the Committee for Medicinal Products for Human Use (CHMP), can be used by companies to obtain further scientific input in the development of their ATMP, thereby increasing their chances of success at the time of applying for a marketing authorisation.

The CAT has been informed that it will receive two new requests for certification for ATMPs in the coming months.

ATMPs are innovative medicines that are derived from gene therapy, cell therapy or tissue engineering. The CAT's main tasks are to review marketing authorisation applications for ATMPs, provide support for scientific advice on ATMPs and scientific recommendations on the classification of medicines as ATMPs, and evaluate early quality and non-clinical data in the framework of a certification.

How useful was this page?

Add your rating