Medicinal products for human use

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

Period of consultation

From 28 June 2016 to 26 September 2016.

Contributions to and results of the consultation

A summary of the responses is available here.

Below are the public responses to the above-mentioned public consultation.

Targeted stakeholders

All stakeholders involved in the development, manufacture and/or commercialisation of advanced therapy medicinal products ("ATMPs"). Comments from small and medium-sized enterprises (SMEs) and academia are particularly welcome.

Objective of the consultation

Article 5 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 manufacturing practice specific to advanced therapy medicinal products.

A consultation on this topic was launched in 2015. On the basis of the comments received during the consultation, as well as input from consultation with the European Medicines Agency and competent authorities in the Member States, the Commission services have developed draft Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products. With this consultation, the Directorate General for Health and Food Safety wants to give an additional opportunity for concerned stakeholders to express their views on the GMP requirements that should apply to ATMPs.

The comments received will be taken into account by the European Commission to finalise the Guidelines on Good Manufacturing 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: