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.
- AMC - ATMP Manufacturing Community
- Action to Focus and Accelerate Cell-based Tolerance-inducing Therapies (A FACTT)
- Alliance for Regenerative Medicine
- Andalusian initiative for advanced therapies
- UZA - Antwerp University Hospital (Belgium)
- AFI - Associazione Farmaceutici Industria
- ATMP-working group in the Netherlands and Belgium
- BPI - Bundesverband der Pharmazeutischen Industrie / German Pharmaceutical Industry Association
- Celica BIOMEDICAL
- Cell Medica Limited
- Cell Therapy Catapult
- Dimension Therapeutics, Inc.
- EPSRC - Centre for Innovative Manufacturing in Regenerative Medicine
- EuropaBio - European Association for Bioindustries
- EBE - European Biopharmaceutical Enterprises
- EUCOPE - European Confederation of Pharmaceutical Entrepreneurs
- EEBA - European Eye Bank Association
- eXmoor pharma concepts
- F. Hoffmann-La Roche Ltd
- Finnish Red Cross Blood Service
- IPFA - International Plasma Fractionation Association
- ISCT - International Society for Cellular Therapy
- King's College Hospital - Professor Farzin Farzaneh
- King's College Hospital - Tamara Elston
- Laboratorio Cellule Staminali, Cell Factory e Biobanca working - Santa Maria Hospital
- LEEM - Les entreprises du médicament
- Leiden University Medical Center - Department of Clinical Pharmacy and Toxicology
- MolMed S.p.A.
- Newcastle Cellular Therapies Facility - Newcastle upon Tyne Hospitals NHS Foundation Trust
- PDA - Parenteral Drug Association
- Professor Mark W Lowdell PhD FRCPath FRSB
- REGenableMED consortium
- ReNeuron Limited
- Roslin Cells Limited
- SchuBiomed Consultancy BV, Utrecht
- Science Pharma
- STEMCELL Technologies
- Swedish National Cell Therapy Group
- TBF Génie Tissulaire
- Technische Universität München - Fakultät für Medizin - TUMCells - Prof. Dr.med. M. Hildebrandt
- UK National Pharmaceutical QA Committee Working Party for ATMPs
- University Hospital Leuven - Ing. Johan Klykens
- VivaBioCell S.p.A.
- Voyager Therapeutics Inc.
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.