Europe's Committee for Advanced Therapies gives first certification opinion for advanced therapies medicinal product for SME

27 May 2010

The European Medicines Agency's (EMEA) Committee for Advanced Therapies (CAT) adopted the first opinion on the certification of experimental data generated for an advanced therapies medicinal product (ATMP) under development by a small and medium-sized enterprise (SME), although it did not identify the applicant.

This is the first time the certification system has been used in the European Union. Introduced by the legislation on advanced therapies in December 2008, the procedure foresees that an SME submits to the Agency data on the quality and, where available, non-clinical data generated with an ATMP from an early stage of development. The CAT carries out a scientific evaluation of these data and may recommend the issuing of a certificate confirming to what extent the data generated so far comply with the review standards that would be applied for the evaluation of a marketing authorization application.

Certification could attract investors or help raise capital

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