The European Medicines Agency released a reflection paper on the classification of advanced-therapy medicines for public consultation. The paper clarifies the legal basis for the classification of medicines as advanced therapies and provides information on how these medicines are classified as gene therapy, somatic-cell therapy, tissue-engineered or combined medicines. It also gives details on the types of information that applicants need to submit to the Agency when applying for classification of their medicine as an advanced therapy, and discusses of some borderline cases and areas where scientific knowledge is limited or evolving rapidly.
Advanced therapies are medicines that are made from genes and cells and may offer groundbreaking new treatment opportunities for many diseases and injuries. As part of its role, the Agency's Committee for Advanced Therapies (CAT) issues opinions on whether a medicine can be classified as an advanced therapy, and can therefore be assessed for a European Union-wide marketing authorisation via the European Medicines Agency.
Download: Reflection paper on classification of advanced therapy medicinal products