Responses to the Public consultation on the concept paper on the Revision of the 'Clinical Trials Directive' 2001/20/EC.

Below are the public responses to the abovementioned public consultation. The following submitting parties requested their submission not to be published: Alexion, Biogen, Arbeitsgruppe Arzneimittel- Apotheken-, Transfusions- und Betäubungsmittelwesen (AG AATB), 'National Institute for Health Research - Clinical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.

A summary of the responses is here(95 KB).

 

• ABI - Association of British Insurers(40 KB)
• ABPI - Association of the British Pharmaceutical Industry(242 KB)
• ACRO - Association of Clinical Research Organizations(336 KB)
• ACPR - Association of Clinical Research Professionals(92 KB)
• AEFI - Spanish Association of Pharmacists in Industry(23 KB)
• AEMPS - Agencia Española de Medicamentos y Productos Sanitarios(1005 KB)
• AESGP - Association of the European Self-Medication Industry(67 KB)
• AGE Platform Europe(43 KB)
• AGES PharmMed (Austria)(34 KB)
• AHPPI - AGAH - Club Phase I - BAPU(131 KB)
• amrc - association of medicinal research charities(107 KB)
• AMS - The Academy of Medical Sciences(87 KB)
• An Bord Altranais(66 KB)
• ASL Milano - Azienda Sanitaria Locale di Milano(60 KB)
• Balling von Cappeln, Inge(102 KB)
• Bardy, Ali Henri(33 KB)
• BHF - British Heart Foundation(58 KB)
• Bio Deutschland(81 KB)
• BMA - British Medical Association(68 KB)
• BPI - German Pharmaceutical Industry Association(105 KB)
• Bristol Myers Squibb(75 KB)
• Bundesärztekammer - German Medical Association(155 KB)  Deutsch (de)
• Bundesinstitut für Arzneimittel und Medizinprodukte und Paul-Ehrlich-Institut, Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel [DE](42 KB) - [EN](45 KB)
• cäiber - Spanish Clinical Research Network(285 KB)
• CCMO (NL) - Centrale Commissie Mensgebonden Onderzoek
  Central Committee on Research involving Human Subjects(305 KB)
• CCRA - Clinical Contract Research Association(48 KB)
• CEIC – Portuguese Ethical Committee for clinical Research(12 KB)
• Celgene(171 KB)
• Chaplin, John PhD Psychologist(27 KB)
• CNCP - Conférence Nationale Francaise des Comites de Protection des
  Personnes dans la Recherche Biomédicale(8 KB)
• COMECE - Commission des Episcopats de la Communauté Européenne Commission of the Bishops’ Conferences of the European -Community Kommission der Bischofskonferenzen der Europäischen Gemeinschaft(266 KB)
• Copenhagen University Hospital(68 KB)
• CPI - Coordination des Promoteurs Institutionnels – Official French Academic Sponsor Coordination(75 KB)
• CPME - Comité Permanent des Médecins Européens - Standing Committee of European Doctors(110 KB)
• CPP idF XI - Comité de Protection des Personnes Ile de France XI(13 KB)
• CRUK Cancer Research UK(272 KB)
• Department of Health & Children, Ireland(109 KB)
• DFG - Deutsche Forschungsgemeinschaft - German Research Foundation [1](62 KB) - [2](62 KB)
• EACPT - European Association for Clinical Pharmacology and Therapeutics(90 KB)
• EATG - European AIDS Treatment Group(609 KB)
• ECPC - European Cancer Patient Coalition(41 KB)
• EFPIA EVM joint response - European Federation of Pharmaceutical Industries and Associations & European Vaccine Manufacturers(133 KB)
• EGA - European Generic Medicines Association(141 KB)
• EGAN - European Genetic Alliance Network(94 KB)
• EHA - European Hematology Association [1](708 KB) - [2](206 KB)
• ehn - european heart network(185 KB)
• EOF - National Organisation for Medicines, Greece(9 KB)
• ECRIN - European Clinical Research Infrastructures Network(257 KB)
• EEC Oncology - European Consulting and Contracting in Oncology(88 KB)
• EMA - European Medecines Agency(165 KB)
• ENCePP - European Network of Centres for Pharmacoepidemiology and Pharmacovigilance(100 KB)
• Enpr-EMA - European network of paediatric research at the EMA(30 KB)
• EORTC - European Organisation for Research and Treatment of Cancer(178 KB)
• EPDA - European Parkinson’s Disease Association(126 KB)
• EPF - European Patients’ Forum [1](680 KB) - [2](409 KB)
• EPHA - European Public Health Alliance(102 KB)
• ESC - European Society of Cardiology(788 KB)
• ESF - European Science Foundation(244 KB)
• ESR - European Society of Radiology(64 KB)
• EUCOPE - European Confederation of Pharmaceutical Entrepreneurs(656 KB)
• EUCROF - European CRO Federation [1](150 KB) - [2](54 KB) 
• EuropaBio - The European Association for Bioindustries(199 KB)
• EURORDIS - Rare Diseases Europe(114 KB)
• FAMHP - Federal Agency for Medicines and Health Products, Belgium(155 KB)
• FEAM Federation of the European Academies of Medicine [1](39 KB) - [2](71 KB)
• fimea - Finnish Medicines Agency(2 MB)
• FMA - Finnish Medical Association(72 KB)
• Forebyggelses- og Patientrådet [1] (2 MB)- [2](91 KB)
• FPM - Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the UK(66 KB)
• France - official position(70 KB)
• GDV - German Insurance Association(67 KB)
• GPOH - Paediatric Oncology and Haematology - Gesellschaft für Pädiatrische Onkologie und Hämatologie(318 KB)
• GE Healthcare(65 KB)
• GILEAD - Gilead Sciences International Limited(41 KB)
• HAI Europe - Health Action International(249 KB)
• Halila, Ritva - M.D., Ph.D. Docent of Medical Ethics(35 KB)
• Hehlmann, Prof. Dr. R.  [1](76 KB) - [2](104 KB)
• HMA - CTFG - Heads of Medicines Agencies - Clinical Trials Facilitation Group [1](486 KB) - [2](55 KB)
• HMR - Hammersmith Medicines Research(12 KB)
• Hoffmann-La Roche Ltd.  [1](183 KB) - [2](2 MB) - [3](396 KB)
• Hungary(17 KB)
• ICORG - Al Ireland cooperative oncology reserch group(103 KB)
• ICRIN - Irish Clinical Research Infrastructure Network(209 KB)
• Independent academic study groups organised in the(2 MB)
  • 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(470 KB)
• IMB - Irish Medicines Board(363 KB)
• Inserm - Institut National de la Santé et de la Recherche Médicale(191 KB)
• ipha - Irish Pharmaceutical Healthcare Association(58 KB)
• ITCC - European academic consortium for Innovative Therapies for
   Children with Cancer(63 KB)
• ITM - Institute of Tropical Medicine, Belgium(222 KB)
• IVDK -  Information Network of Departments of Dermatology for the epidemiological study of
   contact allergies(299 KB)
• IWA Consulting(59 KB)
• Janssen, Pharmaceutical Companies of Johnson & Johnson(33 KB)
• Johnson and  Johnson(7 KB)
• King’s Health Partners(82 KB)
• KKS-Network(86 KB)
• Kuros Biosurgery AG(762 KB)
• LEEM - Les entreprises du médicament(162 KB)
• Les Laboratoires Servier(39 KB)
• Leti Pharma(100 KB)
• London School of Hygiene & Tropical Medicine(200 KB)
• Loreto, Carmona(49 KB)
• MeDALL consortium [1](89 KB) - [2](129 KB)
• Medical Products Agency, Sweden(211 KB)
• Medicines in Europe Forum (MiEF) and of the Association Internationale de la Mutualité (AIM)(28 KB)
• Merck Sharp & Dohme (Europe) Inc.(103 KB)
• mnda - motor neurone disease association(96 KB)
• MRC - Medical Research Council (UK)(104 KB)
• MSC - Medical Schools Council (UK)(59 KB)
• Mundipharma Research(51 KB)
• NHS - National Health Service(61 KB)
• Non-Commercial research organisations in the UK(543 KB)
• Parkinson’s UK(149 KB)
• Pfizer - Worldwide BioPharmaceutical Businesses Public Affairs(52 KB)
• pharma.be [1](82 KB) - [2](257 KB) - [3](2 MB)
• PLUS - Platform of Plasma Protein Users(182 KB)
• PPTA - Plasma Protein Therapeutics Association(85 KB)
• PWPREC (DE) - Permanent Working Party of Research Ethics Committees in Germany(32 KB)
• Royal Academy of Medicine, Spain(120 KB)
• Royal Pharmaceutical Society and National Pharmacy Clinical Trials Advisory Group (NPCTAG)(103 KB)
• Roy-Toole, Christopher [1](96 KB) - [2](54 KB)
• Russel, Mike(57 KB)
• Sanofi aventis - Sanofi pasteur [1](220 KB) - [2](170 KB)
• SEOM - Spanish Society of Medical Oncology(92 KB)
• Sheth, Nilesh [1] (44 KB)- [2](39 KB)
• SIF - Italian Society of Pharmacology(66 KB)
• SIOPE - SIOP Europe, the European Society for Paediatric Oncology(101 KB)
• SOMO wemos - Centre for Research on Multinational Corporations(214 KB)
• Spanish Society Of Clinical Pharmacology(127 KB)
• SUKL Czech Republic - State Institute for Drug Control(147 KB)
• TUFIJA -  The National Committee on Medical Research Ethics in Finland(2 MB)
• UBC - United BioSource Corporation(289 KB)
• UK Government’s response(64 KB)
• UKCRC Registered Clinical Trials Units Network(47 KB)
  • 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](159 KB) - [2](113 KB)
• UZ/KULeuven(19 KB)
• vfa - Die forschenden Pharma-Unternehmen(186 KB)
• wellcome trust(55 KB)
• ZEINCRO(291 KB)

 

• Clinical Trials - Major developments