Month April 2021

CMDh updates April 2021

CMDh Minutes for the meeting on 23-25 March 2021 The minutes from this meeting are available here. List of safety concerns per approved Risk Management Plan (RMP) of active substances per product  The updated list is available here. RMS Validation…

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EMA Q&A on the principles of GMP for the manufacturing of starting materials of biological origin for ATMPs

The EMA has published a Q&A on the principles of GMP for the manufacturing of startingmaterials of biological origin used to transfer genetic material for the manufacturing ofAdvance Therapy Medicinal Products (ATMPs). Is a GMP certificate required for manufacturing and…

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