• EMA Releases Paper on Advanced Therapies to Assist Sponsors

    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...
  • Draft Guideline Released on Assessing Risk of Advanced Therapy Medicinal Products in Europe

    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...