Advanced Therapies
How are Advanced Therapies with Gene Therapy, Somatic Cell Therapy and Tissue Engineering regulated within the EU?
The main elements of the Regulation are:
- A centralised marketing authorisation procedure, to benefit from the pooling of expertise at European level and direct access to the EU market.
- A new and multidisciplinary expert Committee (Committee for Advanced Therapies), within the European Medicines Agency (EMA), to assess advanced therapy products and follow scientific developments in the field.
- Technical requirements adapted to the particular characteristics of these products.
- Special incentives for small and medium-sized enterprises.
This new Regulation also marks the recognition that a number of advanced therapy products actually combine biological materials, such as tissues or cells, and chemical structures such as metal implants or polymer scaffolds. These combination products lie at the border of the traditional pharmaceutical area and other fields (e.g. medical devices). They therefore cannot be regulated as 'conventional' drugs and need adapted requirements. In addition, it should be borne in mind that a significant share of economic operators involved in this field are not large pharmaceutical companies, but rather small and medium-sized enterprises or hospitals.
