The European Medicines Agency (EMA) has released a new reflection paper on the classification of advanced-therapy medical products (ATMPs)-therapies made from genes and cells-which aims to clarify the legal basis for the classification of advanced therapies and provide information to applicants on how to submit applications for approval to EMA. In particular, the paper "provides information on how these medicines are classified as gene therapy, somatic-cell therapy, tiss...

The European Medicines Agency (EMA) needs to assist companies-particularly small businesses, academic institutions and charities-in the development of advanced-therapy medicines, claims a new paper written by members of the Committee for Advanced Therapies (CAT) in the journal Molecular Therapies . These smaller drug development entities often lack the resources necessary to "navigate regulatory procedures," including clinical trials and application submissions. The pa...

The European Medicines Agency (EMA) released a new draft guideline on 24 January assessing Advanced Therapy Medicinal Products (ATMPs) using a risk-based approach. ATMPs are biological medicinal products such as gene therapy, somatic cell therapy or tissue-engineered products. According to EMA , ATMPs contain an active substance which contains or consists of a recombinant nucleic acid used in or administered to human beings with a view to regulating, repairing, replac...