gives recommendations on the classification of advanced therapy medicines. The European Commission makes its final decision on the basis of the CHMP opinion. Based on the CAT opinion, the CHMP adopts an opinion recommending or not the authorisation of the medicine by the European Commission. It sends this to the Committee for Medicinal Products for Human Use ( CHMP). It provides the expertise that is needed to evaluate advanced therapy medicines.ĭuring the assessment procedure, the CAT prepares a draft opinion on the quality, safety and efficacy of the advanced therapy medicine. The Agency's Committee for Advanced Therapies ( CAT) plays a central role in the scientific assessment of advanced therapy medicines. To apply for this EMA pilot, developers should fill in the application form below and send it to is also available to inform applicants on aspects such as: Initial results are expected after three to four years. This EMA pilot aims to assess the level of regulatory support needed to boost the number of advanced therapy medicines that reach patients in the European Economic Area. Guidance throughout the regulatory process, from manufacturing best practice to clinical development and follow-up planning on efficacy or safety issues.Up to five ATMP developers targeting unmet clinical needs will receive dedicated assistance that includes: In April 2020, EMA's Committee for Advanced Therapies (CAT) advised patients and the general public to beware of unproven cell-based therapies.Īcademic and non-profit organisations involved in developing promising advanced therapy medicines (ATMPs) can apply for EMA's increased support in meeting regulatory requirements. An example of this is cells embedded in a biodegradable matrix or scaffold.įor detailed definitions of the different groups of advanced therapy medicinal products, refer to Regulation (EC) No 1394/2007 and Directive 2001/83/EC. In addition, some ATMPs may contain one or more medical devices as an integral part of the medicine, which are referred to as combined ATMPs. tissue-engineered medicines: these contain cells or tissues that have been modified so they can be used to repair, regenerate or replace human tissue.They can be used to cure, diagnose or prevent diseases somatic-cell therapy medicines: these contain cells or tissues that have been manipulated to change their biological characteristics or cells or tissues not intended to be used for the same essential functions in the body.A recombinant gene is a stretch of DNA that is created in the laboratory, bringing together DNA from different sources They work by inserting 'recombinant' genes into the body, usually to treat a variety of diseases, including genetic disorders, cancer or long-term diseases. gene therapy medicines: these contain genes that lead to a therapeutic, prophylactic or diagnostic effect.They offer groundbreaking new opportunities for the treatment of disease and injury.ĪTMPs can be classified into three main types: Advanced therapy medicinal products (ATMPs) are medicines for human use that are based on genes, tissues or cells.
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