PIC/S sent a letter in response to a reply received from the European Commission on 5 April 2017 in connection with PIC/S' stance on the proposed EU Advanced Therapy Medicinal Products (ATMP) GMP Guidelines, which will not only lower GMP standards for ATMP at the risk of patients but also lead to an internationally non-harmonised approach to the implementation of GMP for ATMP.
In its latest letter, PIC/S reaffirms its position and highlights gaps relating to patient safety, while welcoming the Commission's proposal for engagement with PIC/S on its initiative and seeking clarification on the scope of cooperation proposed.
For reasons of transparency and rights of patients, this letter has been published via the link below:
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