The field of advanced therapy medicinal products has been regulated recently and for this reason the applicative aspects are still quite sketchy.
The Marketing Authorization Application of advanced therapy medicinal products prepared industrially and to be marketed in the Member States is issued by the CHMP of the EMA on the advice of the Committee for Advanced Therapies, through the centralized procedure.
The main European standard reference is the Directive 2001/83/EC and Regulation (EC) No. 1394/2007 establishing the European Committee for Advanced Therapies.
Di Renzo Regulatory Affairs has the expertise to provide companies with the necessary regulatory advice in this area.