Medicinal products

Targeted stakeholder consultation on the development of Good Manufacturing Practice for Advanced Therapy Medicinal Products pursuant to Article 5 of Regulation 1394/2007


Period of consultation

From 23 July 2015 to 12 November 2015.

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. Comments from small and medium-sized enterprises (SMEs) 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 ("GMPs") specific to advanced therapy medicinal products ("ATMPs").

With this public consultation, the Directorate General for Health and Food Safety intends to seek the view of stakeholders regarding the GMP requirements for ATMPs.

The comments received will be taken into account by the European Commission when developing the Guidelines on good manufacturing practice specific to ATMPs.

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: