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.
- Alliance for Regenerative Medicine
- ATMP Manufacturing Community (UK)
- Andalusian Initiative for Advanced Therapies
- apceth Biopharma GmbH
- ATMP working group Netherlands & Belgium
- Aurealis Pharma
- Bioquell UK
- Bone Therapeutics
- BPI - Bundesverband der Pharmazeutischen Industrie / German Pharmaceutical Industry Association
- CCMI - Centre for Cell Manufacturing Ireland
- Cell and Gene Therapy Catapult
- Cell Medica Limited
- Cook Group Incorporated
- EAHP - European Association of Hospital Pharmacists
- EBA - European Blood Alliance
- EBE - European Biopharmaceutical Entreprises / EFPIA - European Federation of Pharmaceutical Industries and Associations
- EIPG - European Industrial Pharmacists Group
- EUCOPE - European Confederation of Pharmaceutical Entrepreneurs
- EuropaBio - European Association for Bioindustries
- eXmoor pharma concepts :  - 
- Finnish Red Cross Blood Service
- G. M. Lewis
- ISCT - International Society for Cellular Therapy
- ISPE - International Society for Pharmaceutical Engineering
- Lentigen Technology
- Mares Ltd.
- Merck KGaA
- National Institute for Health Research - Biomedical Research Centre
- National Pharmacy Clinical Trials Advisory Group
- Newcastle Cellular Therapies Facility
- NHS Advanced Therapy Medicinal Products Working Party
- Novadip Biosciences
- Oxford BioMedica
- P. Kemp
- PCI Pharma Services
- Polski Bank Komórek Macierzystych - Famicord Group
- PPD Global Ltd.
- Professor Mark W Lowdell PhD FRCPath FRSB
- Promethera Biosciences
- Regea Cell and Tissue Center - BioMediTech, University of Tampere (Finland)
- REGenableMED consortium
- Swedish National Cell Therapy Group
- UZA - Antwerp University Hospital (Belgium)
- VivaBioCell S.p.A.
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.