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

Public health community

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.

Results of the Consultation

• Summary report
• All responses received

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:

• Advanced therapies
• Advanced therapies - Major developments
• EMA - Advanced therapy medicinal products

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-B5ec [dot] europa [dot] eu (sante-pharmaceuticals-B5[at]ec[dot]europa) by referiing by containing the reference "TSC 01/2018 on GCP for ATMPs”.