Details
- Status
- Closed
- Opening date
- Deadline
- Department
- Directorate-General for Health and Food Safety
Target audience
Public health community
Why we are consulting
Period of consultation
From 4 July 2008 to 15 October 2008.
Contributions to and results of the consultation
Below are the public responses to the above-mentioned public consultation:
- Bayerisches Staatsministerium für Umwelt, Gesundheit und Verbraucherschutz
- BioIndustry Association (BIA)
- Cook Medical
- Eucomed
- EuropaBio
- European Biopharmaceutical Enterprises (EBE)
- European Medicines Agency (EMEA)
- F. Hoffmann-La Roche
- German Pharmaceutical Industry Association (BPI)
- International Xenotransplantation Association (IXA)
- Irish Medicines Board
- Minstère de la Santé, Direction générale de la santé
- Ministry of Health, Welfare and Sports (Netherlands)
- North-East England Stem Cell Institute (NESCI)
- Paul Ehrlich Institut
- RISET, EU FP6 integrated project Reprogramming the Immune System for the Establishment of Tolerance
- TBF Génie Tissulaire
- XENOME, the EU FP6 Integrated Project on xenotransplantation
Targeted stakeholders
Comments on this document are invited from all stakeholders dealing with advanced therapy medicinal products. Stakeholders who are not established within the European Union are equally invited to comment. Comments from Small and Medium-sized Enterprises (SMEs) involved in the sector are especially welcomed.
Objective of the consultation
Regulation (EC) No 1394/2007 on advanced therapy medicinal products ("the Regulation") lays down specific rules concerning the authorisation, supervision and pharmacovigilance of advanced therapy medicinal products (gene therapy, somatic cell therapy and tissue engineering). This Regulation will apply from 30 December 2008.
The European Commission has published on 13 December 2007 an implementation plan, outlining its priorities for the implementation of the Regulation. The implementation plan has been developed and agreed with the European Medicines Agency (EMEA).
As part of this plan, Article 4 of the Regulation requires that detailed guidelines on good clinical practice (GCP) specific to advanced therapy medicinal products be drawn up. This public consultation document presents preliminary proposals to draft such guidance.
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.