The field of the medicinal products for advanced therapies has been regulated almost recently and for this reason the application is still difficult.

The marketing authorization for medicines for advanced therapies industrially manufactured and intended to the markets of the EU Member States is issued by the EMA CHMP following the opinion of the Advanced Therapy Committee by Centralized Procedure.

The reference European regulation is Directive 2001/83/EC and Regulation no. 1394/2007 instituting the European Committee for Advanced Therapies.

Di Renzo Regulatory Affairs has the competence to provide companies with the needed regulatory support in this field.