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the Committee for Orphan Medicinal Products ( COMP) has granted orphan designation to a number of medicines containing stem cells for the treatment of rare diseases.the Scientific Advice Working Party has given advice on the development of at least seven medicines containing stem cells.the CAT has classified a number of medicines containing stem cells as ATMPs.The Agency has been advising developers of stem cell-based medicines for a number of years: They can be somatic-cell therapy products or tissue-engineered products, depending on how the medicine works in the body.ĮMA follows research into the use of stem cells in medicines very closely and is responsible for assessing marketing authorisation applications for medicines containing stem cells.
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Stems cells are categorised as ATMPs when these cells undergo substantial manipulation or are used for a different essential function. Stem cells are important in the growth and development of the body, as well as in repair after injury. Stem cells are naturally occurring cells in the body that have the ability to divide and produce a range of different cell types.
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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. In April 2020, EMA's Committee for Advanced Therapies (CAT) advised patients and the general public to beware of unproven cell-based therapies. 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.
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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.