ATMP Annual Report 2016

In the actual “Annual Report 2016” the EMA published, that the number of adopted recommendations for advanced therapy medicinal products (ATMP) increased continuously over the last 4 years and reached a peak in 2016.

ATMPs are defined as “advanced therapies, such as gene therapy, somatic cell therapy, and tissue engineering.”They have a big potential for treatment of diseases where conventional approaches are inadequate. ATMP developers have the opportunity to apply their draft opinion on ATMP application. Before the appropriate authority CHMP (Committee for Medicinal Products for Human Use) adopts a final decision, the brains trust of CAT (Committee for Advanced Therapies) is responsible to review the certification of quality and non-clinical data and provides scientific recommendations on the classification of ATMPs for assessing the quality, safety and efficacy of ATMPs.

In 2016, the number of ATMPs argued for recommendation increased from 31 to 87 in comparison to 2015. Thereby, the small and medium-sized enterprises (SME) represented a significant higher proportion than academia. All this leads to a situation that ATMP will have higher impact in medical treatment in the future.

EMA Annual Report 2016

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