. New GMP Guidelines for Advanced Therapies Released by European Commission

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New GMP Guidelines for Advanced Therapies Released by European Commission

The European Commission has published a set of guidelines on good manufacturing practice (GMP) specific to advanced therapy medicinal products (ATMPs).

New advanced medicinal therapies are based on medicines for human use that involve genes or cells. These therapies offer ground-breaking new opportunities for the treatment of diseases and injuries. They are particularly important for severe, untreatable or chronic diseases for which conventional approaches have proven to be inadequate.

European Union new GMP guidelines covers all the requirements to the specific characteristics of ATMPs and address the novel and complex manufacturing scenarios utilised for these products. The guidelines addresses a risk based approach to manufacture and testing of new advanced products. The guidelines ensure that these novel medicinal products are consistently produced and controlled according to high quality standards, for the benefit and the safety of patients. Directorate General for Health and Food Safety (DG SANTE) icon and the European Medicines Agency (EMA) in October 2017 launched a joint initiative to facilitate the development of ATMPs.

The European Commission drafted these guidelines with extensive input from the Agency’s Committee for Advanced Therapies (CAT) and GMP/Good distribution practice (GDP) inspectors working group (GMDP IWG), together with national competent authorities and other external stakeholders. The adaptations introduced in the GMP framework for ATMPs will continue ensuring a high level of quality for ATMPs and a high level of patient protection.

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