The four types of advanced therapy medicinal products (ATMP) are:
- The “gene therapy” medicines
- The “somatic cell therapy” medicines
- The ” cell or tissue engineered ” medicines
- The “combined advanced therapy medicinal products”.
The MTI, like any medicinal product, must obtain a marketing authorization (MA). The MA must be granted for these products as part of a centralized authorisation procedure. It is issued by the European commission after evaluation by the European Medicines Agency.
The evaluation is carried out by the Committee for medicinal products for human use (CHMP) in collaboration with the “Committee for Advanced Therapies” (CAT) (Committee of experts in charge of the evaluation of the quality, safety and effectiveness of the MTI,).
WHITE-TILLET advises and assists you in:
- The preparation of the marketing authorisation file;
- The submission and managing of the specific procedure;
- The modifications;
- The risk management.
24 Rue Gambetta 77400 LAGNY-SUR-MARNE, France