Details
- Status
- Closed
- Opening date
- Deadline
- Department
- Directorate-General for Health and Food Safety
Target audience
Public health community
Why we are consulting
The European Commission is planning to put forward, in 2012, a legislative proposal to revise the Clinical Trials Directive 2001/20/EC.
Period of consultation
From 9 February 2011 to 13 May 2011.
Contributions to and results of the consultation
A summary of the responses is available here.
The following submitting parties requested their submission not to be published: Alexion, Biogen, Arbeitsgruppe Arzneimittel- Apotheken-, Transfusions- und Betäubungsmittelwesen (AG AATB), "National Institute for Health Research - Clinical Research Network Coordinating Centre", University of Bristol.
Below are the public responses to the abovementioned public consultation:
- ABI - Association of British Insurers
- ABPI - Association of the British Pharmaceutical Industry
- ACRO - Association of Clinical Research Organizations
- ACPR - Association of Clinical Research Professionals
- AEFI - Spanish Association of Pharmacists in Industry
- AEMPS - Agencia Española de Medicamentos y Productos Sanitarios
- AESGP - Association of the European Self-Medication Industry
- AGE Platform Europe
- AGES PharmMed (Austria)
- AHPPI - AGAH - Club Phase I - BAPU
- amrc - association of medicinal research charities
- AMS - The Academy of Medical Sciences
- An Bord Altranais
- ASL Milano - Azienda Sanitaria Locale di Milano
- Balling von Cappeln, Inge
- Bardy, Ali Henri
- BHF - British Heart Foundation
- Bio Deutschland
- BMA - British Medical Association
- BPI - German Pharmaceutical Industry Association
- Bristol Myers Squibb
- Bundesärztekammer - German Medical Association
- Bundesinstitut für Arzneimittel und Medizinprodukte und Paul-Ehrlich-Institut, Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel : [DE] - [EN]
- cäiber - Spanish Clinical Research Network
- CCMO (NL) - Centrale Commissie Mensgebonden Onderzoek / Central Committee on Research involving Human Subjects
- CCRA - Clinical Contract Research Association
- CEIC – Portuguese Ethical Committee for clinical Research
- Celgene
- Chaplin, John PhD Psychologist
- CNCP - Conférence Nationale Francaise des Comites de Protection desPersonnes dans la Recherche Biomédicale
- COMECE - Commission des Episcopats de la Communauté Européenne Commission of the Bishops’ Conferences of the European -Community Kommission der Bischofskonferenzen der Europäischen Gemeinschaft
- Copenhagen University Hospital
- CPI - Coordination des Promoteurs Institutionnels – Official French Academic Sponsor Coordination
- CPME - Comité Permanent des Médecins Européens - Standing Committee of European Doctors
- CPP idF XI - Comité de Protection des Personnes Ile de France XI
- CRUK Cancer Research UK
- Department of Health & Children, Ireland
- DFG - Deutsche Forschungsgemeinschaft - German Research Foundation : [1] - [2]
- EACPT - European Association for Clinical Pharmacology and Therapeutics
- EATG - European AIDS Treatment Group
- ECPC - European Cancer Patient Coalition
- EFPIA EVM joint response - European Federation of Pharmaceutical Industries and Associations & European Vaccine Manufacturers
- EGA - European Generic Medicines Association
- EGAN - European Genetic Alliance Network
- EHA - European Hematology Association : [1] - [2]
- ehn - european heart network
- EOF - National Organisation for Medicines, Greece
- ECRIN - European Clinical Research Infrastructures Network
- EEC Oncology - European Consulting and Contracting in Oncology
- EMA - European Medecines Agency
- ENCePP - European Network of Centres for Pharmacoepidemiology and Pharmacovigilance
- Enpr-EMA - European network of paediatric research at the EMA
- EORTC - European Organisation for Research and Treatment of Cancer
- EPDA - European Parkinson’s Disease Association
- EPF - European Patients' Forum : [1] - [2]
- EPHA - European Public Health Alliance
- ESC - European Society of Cardiology
- ESF - European Science Foundation
- ESR - European Society of Radiology
- EUCOPE - European Confederation of Pharmaceutical Entrepreneurs
- EUCROF - European CRO Federation : [1] - [2]
- EuropaBio - The European Association for Bioindustries
- EURORDIS - Rare Diseases Europe
- FAMHP - Federal Agency for Medicines and Health Products, Belgium
- FEAM Federation of the European Academies of Medicine : [1] - [2]
- fimea - Finnish Medicines Agency
- FMA - Finnish Medical Association
- Forebyggelses- og Patientrådet : [1] - [2]
- FPM - Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the UK
- France - official position
- GDV - German Insurance Association
- GPOH - Paediatric Oncology and Haematology - Gesellschaft für Pädiatrische Onkologie und Hämatologie
- GE Healthcare
- GILEAD - Gilead Sciences International Limited
- HAI Europe - Health Action International
- Halila, Ritva - M.D., Ph.D. Docent of Medical Ethics
- Hehlmann, Prof. Dr. R. : [1] - [2]
- HMA - CTFG - Heads of Medicines Agencies - Clinical Trials Facilitation Group : [1] - [2]
- HMR - Hammersmith Medicines Research
- Hoffmann-La Roche Ltd. : [1] - [2] - [3]
- Hungary
- ICORG - Al Ireland cooperative oncology reserch group
- ICRIN - Irish Clinical Research Infrastructure Network
- Independent academic study groups organised in the
- German Society for Haematology and Oncology
- Competence Network for Acute and Chronic Leukaemias
- Competence Network for Malignant Lymphom
- European Leukemia Net
- IDF - International Diabetes Federation Europe
- IMB - Irish Medicines Board
- Inserm - Institut National de la Santé et de la Recherche Médicale
- ipha - Irish Pharmaceutical Healthcare Association
- ITCC - European academic consortium for Innovative Therapies for Children with Cancer
- ITM - Institute of Tropical Medicine, Belgium
- IVDK - Information Network of Departments of Dermatology for the epidemiological study of contact allergies
- IWA Consulting
- Janssen, Pharmaceutical Companies of Johnson & Johnson
- Johnson and Johnson
- King’s Health Partners
- KKS-Network
- Kuros Biosurgery AG
- LEEM - Les entreprises du médicament
- Les Laboratoires Servier
- Leti Pharma
- London School of Hygiene & Tropical Medicine
- Loreto, Carmona
- MeDALL consortium : [1] - [2]
- Medical Products Agency, Sweden
- Medicines in Europe Forum (MiEF) and of the Association Internationale de la Mutualité (AIM)
- Merck Sharp & Dohme (Europe) Inc.
- mnda - motor neurone disease association
- MRC - Medical Research Council (UK)
- MSC - Medical Schools Council (UK)
- Mundipharma Research
- NHS - National Health Service
- Non-Commercial research organisations in the UK
- Parkinson's UK
- Pfizer - Worldwide BioPharmaceutical Businesses Public Affairs
- pharma.be : [1] - [2] - [3]
- PLUS - Platform of Plasma Protein Users
- PPTA - Plasma Protein Therapeutics Association
- PWPREC (DE) - Permanent Working Party of Research Ethics Committees in Germany
- Royal Academy of Medicine, Spain
- Royal Pharmaceutical Society and National Pharmacy Clinical Trials Advisory Group (NPCTAG)
- Roy-Toole, Christopher : [1] - [2]
- Russel, Mike
- Sanofi aventis - Sanofi pasteur : [1] - [2]
- SEOM - Spanish Society of Medical Oncology
- Sheth, Nilesh : [1] - [2]
- SIF - Italian Society of Pharmacology
- SIOPE - SIOP Europe, the European Society for Paediatric Oncology
- SOMO wemos - Centre for Research on Multinational Corporations
- Spanish Society Of Clinical Pharmacology
- SUKL Czech Republic - State Institute for Drug Control
- TUFIJA - The National Committee on Medical Research Ethics in Finland
- UBC - United BioSource Corporation
- UK Government's response
- UKCRC Registered Clinical Trials Units Network
- Cancer Prevention Trials Unit (Barts and the London School of Medicine and Dentistry)
- CRUK and UCL Cancer Trials Centre, London
- CTRU (University of Leeds)
- National Perinatal Epidemiological Unit (Oxford)
- Newcastle Clinical Trials Unit (University of Newcastle)
- US Department of Health and Human Services : [1] - [2]
- UZ/KULeuven
- vfa - Die forschenden Pharma-Unternehmen
- wellcome trust
- ZEINCRO
Objective of the consultation
The European Commission is planning to put forward, in 2012, a legislative proposal to revise the Clinical Trials Directive 2001/20/EC.
This concept paper is being put out for public consultation. It presents:
- A "preliminary appraisal" of which option appears to be the most suitable one to address some of the key concerns of the Clinical Trials Directive, on the basis of the current state of the impact assessment; and
- The main figures that are being used to evaluate the impacts of the different policy options.
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.
Additional information:
Respond to the consultation
The response period for this consultation has ended. Thank you for your input.