Companies can consult the EMA to determine whether their medicine being developed is an advanced therapy medicinal product (ATMP). The European Medicines Agency (EMA) has released their classification decisions for 19 products. The procedure will help manufacturers whose products are borderline between different classifications.
“Any applicant developing a product based on genes, cells or tissues may request a scientific recommendation of the Agency with a view to determining whether the referred product falls, on scientific grounds, within the definition of an advanced therapy medicinal product,” the regulation says.
The classification procedure is optional and the criteria for ATMPs are set out in Article 17 of Regulation (EC) No 1394/2007.