News related to Regenerative Medicine, Tissue Engineering, Medical devices, Pharmaceutical industry with focus on achievements and the legal, ethical, and regulatory aspects of the field
Several weeks ago, the summary of the responses to the consultation on the development of Guidelines for Good Manufacturing Practice for Advanced Therapy Medicinal Products was announced. It has been developed on the basis of the comments received during the consultation as well as input from consultation with the European Medicines Agency and competent authorities in the Member States. The Commission services developed draft Guidelines on Good Manufacturing Practice (“GMP”) specific to ATMPs.
You can read more at European Commission website.
Medical device file / Dokumentacja wyrobu medycznego wymieniona w punkcie 4.2.3 Normy PN-EN ISO 13485 czasem nazywana przez …