Medicinal products

Targeted stakeholder consultation on the draft Guidelines on Good Clinical Practice for Advanced Therapy Medicinal Products

Targeted stakeholders

The stakeholders involved in the clinical trials of advanced therapy medicinal products ("ATMPs"). Comments from small and medium-sized enterprises (SMEs), academia, hospitals and patient organisations are particularly welcome.

Objective of the consultation

Article 4 of Regulation 1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products and amending Directive 2001/83/EC requires the Commission to draw up guidelines on good clinical practice specific to advanced therapy medicinal products.

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 (ICH). 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 document

The consultation document can be downloaded here

Protection of personal data

The policy on "protection of individuals with regard to the processing of personal data by the Community institutions" is based on Regulation (EC) N° 45/2001 of the European Parliament and of the Council of 18 December 2000. More information is available here.

Specific privacy statement

Please consult the Privacy Statement to be downloaded here.

Additional information:

How to submit your contribution

Stakeholders are invited to comment on this consultation by 31 October 2018 at the latest. Responses should preferably be sent to sante-pharmaceuticals-B5@ec.europa.eu

They can also be sent by post to Directorate-General for Health and Food Safety, Unit SANTE B/5, BE-1049 Brussels. The subject line of the letter or email should contain the reference "TSC 01/2018 on GCP for ATMPs".

When submitting your response, please include your name and e-mail address and specify if you are responding as an individual or as a representative of an organisation. If you represent an organisation, please indicate its name and category (company/business; public authority (local, regional, national, international); patient organisation; healthcare professional organisation; academic; NGO; other).

Contact details

Any queries about the targeted stakeholder consultation should be sent to: Unit B5 - Medicines: policy, authorisation and monitoring, Directorate-General for Health and Food Safety sante-pharmaceuticals-B5@ec.europa by referiing by containing the reference "TSC 01/2018 on GCP for ATMPs”.