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PIC/S sent a letter to the European Commission (EC) expressing concern that the perceived lessening of the GMP requirements in the EC’s proposed Advanced Therapy Medicinal Products (ATMP) GMP guidelines would: ● expose patients to an increased risk to their health ● expose liabilities for any health incident (and related court action), and ● lead to an internationally non-harmonized approach to the implementation of GMP for ATMP. The PIC/S position was supported by the Alliance for Regenerative Medicine (ARM). ARM European Public Policy Director Annie Hubert stated that “ARM, like the majority of other respondents to the 2015 and 2016 consultations on the ATMP GMP guideline, consistently advocated for an integration of the GMP for ATMPs as an annex to the EudraLex Volume 4 of the Rules Governing Medicinal Products in the European Union.” The EC noted in its summary that a significant number of stakeholders, in their responses, suggested that further adaptations of the guidelines to reflect the specific characteristics of ATMPs were needed.
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