Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders
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Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders

This Reflection Paper is focussed on the GMP-related responsibilities that apply to Marketing Authorisation Holder companies. While it is recognised that many MAH companies are not directly engaged in the manufacture of medicinal products themselves, the current European Commission guide to GMP refers, in several places, to MAHs and their responsibilities in relation to GMP.

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Guidelines on Good Clinical Practice specific to Advanced Therapy Medicinal Products
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Guidelines on Good Clinical Practice specific to Advanced Therapy Medicinal Products

Compliance with good clinical practice (“GCP”) is mandatory for clinical trials that are conducted in the EU. These Guidelines develop the GCP requirements that are specific to clinical trials conducted with ATMPs. These Guidelines are to be read in conjunction with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines on good clinical practice,3 which are also applicable to ATMPs.

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