Public consultation on draft revision 3 of Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial.
Period of consultation
From 22 June 2009 to 8 September 2009.
Contributions to and results of the consultation
The following submitting parties requested their submission not to be published: Actogenix.
Below are the public responses to the above-mentioned public consultation:
- ACRO - Association of Clinical Research Organizations
- AEMPS - Agencia española de medicamentos y productos sanitarios
- AESGP - Association of the European Self-Medication Industry
- afssaps - Agence française de sécurité sanitaire des produits de santé
- afssaps - Directorate for evaluation of medicinal and biological products
- Agence Fédérale des Médicaments et des Produits de Santé, Belgique
- Jane Armitage, Professor of Clinical Trials & Epidemiology and Dr Martin Landray, Reader in Clinical Epidemiology University of Oxford
- Astellas Pharma Europe R&D - Dr. K.L. Kam, Kweelan - Associate Regulatory Affairs Director Development Section
- Colin Baigent MRC Scientist University of Oxford
- BARQA - British Association for Research Quality Assurance - Dr. Colin Wilsher. BARQA GCP Commiittee
- Academic Dean (Brookwood International Academy/Canary Ltd)- Professor Dr David Hutchinson - Visiting Professor of Clinical Research & GCP
- Clinical Research network coordinating centre nihrcrncc - THE UKCRC REGISTERED CLINICAL TRIALS UNITS
- Collins Rory
- CROM srl - Contract Research Organisation for Medical and Pharmaceutical Project
- CTRU Leeds
- Danish Medicines Agency - Consumer Safety
- Danish Medicines Agency
- EFPIA - European Federation of Pharmaceutical Industries and Associations
- EORTC - European Organisation for Research and Treatment of Cancer
- GE Healthcare - Matthews Yvonne
- German Pharmaceutical Industry Association (Germany)
- Gilead Sciences inc.
- Hammersmith Medicines Research Ltd.
- F. Hoffmann-La Roche Ltd.
- D.r N. Johnson
- KKS Netzwerk - Koordinierungszentren für Klinische Studien
- Les Laboratoires Servier
- LFB BIOTECHNOLOGIES - Françoise ROSSI
- H. Lundbeck A/S - Dr. Iman Barilero, Pharm D, MSc, PhD
- MHRA guidelines
- Novo Nordisk A/S
- ONO Pharmaceuticals UK Ltd - Fred Lackenby - Regulatory Affairs Manager
- Real Regulatory - Karen Real, Director
- EU FP6 integrated project "RISET" - Pr. Michel Goldman/Kathryn Wood
- Road Map Initiative for Clinical Research in Europe
- Swedish Medicinal Products Agency
- University Hospitals Birmingham NHS Foundation Trust - Nicola Parrott - Cancer Research Business Manager
- WYETH Pharmaceuticals
Contributions are invited from all stakeholders related to clinical trials. Stakeholders who are not established within the European Union are equally invited to comment.
Objective of the consultation
The Clinical Trials Directive provides a regime of authorisation of the NCA, notification of substantial amendments, and declaration of the end of the trial, and exhaustively harmonises these aspects. The Commission is under an obligation to draw up detailed guidance to ensure that the format and content of the request for authorisation of a clinical trial are harmonised. A draft revision of the existing detailed guidance is being submitted for public consultation.
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.