+390677209020 | +39 0267380552 info@direnzo.biz | sedemilano@direnzo.biz


Terapie Avanzate

Advanced therapies

Advanced therapy medicinal products (ATMPs) are human medicines based on genes, tissues or cells, offering new revolutionary opportunities for the treatment of diseases and lesions.

The Marketing Authorization (MA) of advanced therapy medicinal products prepared industrially and intended for the market of EU Member States is issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on advice of the Committee for Advanced Therapies (CAT), through the centralized procedure (CP).

The main European standard reference is Directive 2001/83/EC (implemented by Legislative Decree no. 219 of 24 April 2006) and Regulation (EC) 1394/2007 establishing the European Committee for Advanced Therapies.

Thanks to the presence of several regulatory experts among its staff, Di Renzo Regulatory Affairs has the expertise to provide companies with the necessary regulatory advice in this sector.