Openbare raadpleging door de Europese Commissie over de ontwerprichtsnoeren inzake goede klinische praktijk voor geneesmiddelen voor geavanceerde therapie – deadline: 31 oktober 2018

 In Nieuws

The European Commission is launching an online targeted public consultation on the draft guideline on Good Clinical Practice for Advanced Therapy Medicinal Products (ATMPs) addressed particularly to small and medium-sized enterprises, academia, hospitals and patients’ organisations.

Taking account the advances and experience in the field the Commission services have developed a new draft Guidelines on Good Clinical Practice specific to Advanced Therapy Medicinal Products with the European Medicines Agency and the expert group of the competent authorities of the Member States. The Guidelines will adapt good clinical practice requirements (GCPs) to ATMPs. It will be a document that focuses on ATMP specificities only and which applies in addition to the GCP Guidelines of The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. The Directorate General for Health and Food Safety wants to give an opportunity for concerned stakeholders to express their views on the GCP requirements that should apply to ATMPs.

The comments received will be taken into account by the European Commission in the finalisation of the Guidelines on Good Clinical Practice specific to Advanced Therapy Medicinal Products.

The consultation paper is available by clicking here. Stakeholders are invited to comment on this consultation by 31 October 2018. Responses should be sent to sante-pharmaceuticals-B5@ec.europa.eu.

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