Legislation and guidelines regarding clinical trials of human medicines

Regulations and guidelines

• Regulation for clinical trials of medicinal products for human use : Clinical Trial Regulation (EU) No. 536/2014 (pdf) – CTR

• A quick guide to CTR: Clinical Trials Regulation (EU) No 536/2014 in practice: 
• Questions and Answers Document - Regulation (EU) 536/2014 - Annex II of the Q&A provides the language requirements for part I documents. Annex III of the Q&A provides lists of Member States websites specifying national requirements and contact details for Part I and Part II application. 
• EudraLex Volume 10: This volume contains guidance documents applying to clinical trials in the EU/EEA (see information over).
• WMA Declaration of Helsinki - Ethical principles for medical research involving human subjects
• ICH E6 (R3) Good Clinical Practice (External link): This guide provides an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects  
• Guidance document: Recommendations related to contraception and pregnancy testing in clinical trials (External link). 
• ICH M3 (R2) Non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals (External link): This document aims to recommend international standards for the non-clinical safety studies recommended to support human clinical trials for pharmaceuticals. 
• ICH S9 Non-clinical evaluation for anticancer pharmaceuticals (External link): This guideline aims to assist in the design of non-clinical studies for the development of anticancer pharmaceuticals. 
• Requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials(External link):  This guidance addresses the documentation on the chemical and pharmaceutical quality of investigational medicinal product dossier containing chemically defined drug substances, synthetic peptides, herbal substances, herbal preparations and chemically defined radio-active/radio-labelled substances. 
• Requirements for quality documentation concerning biological investigational medicinal products in clinical trials(External link):  This guidance addresses the specific documentation requirements on the biological, chemical and pharmaceutical quality of investigational medicinal product (IMP) containing biological/biotechnology derived substances. 

National regulations and guidelines

• National legislation (in Norwegian only): Legemiddelforskriften Forskrift om legemidler til mennesker 
• Guidance on the import of medicinal products for clinical studies in Norway (dmp.no) 
• Relabelling of an investigational medicinal product with a new expiry date (in Norwegian only): When there is a need to relabel the investigational medicinal product(s) with a new expiry date after the products have been distributed to the trial site or to another short-term storage location

Other useful websites

• Clinical Trials Information System (CTIS) – CTIS is the single-entry portal for submitting applications and interacting on clinical trials in the EU and EEA – see also our webpage on CTIS .
• Clinical Trials Coordination Group (CTCG) is a working group of experts in the classification, assessment and oversight of clinical trials from National Agencies. Contains useful guidelines and templates. 
• Accelerating Clinical Trials in the EU (ACT EU) is an initiative that aims to develop the EU & EEA further as a competitive centre for innovative clinical research. It also aims to transform how clinical trials are initiated, designed and run to further promote the development of high quality, safe and effective medicines, and to better integrate clinical research in the European health system. 
• EU Clinical Trials Register is a database for clinical trials conducted in the EU/EEA under Directive (EU) No. 2001/20.
• ClinicalTrials.gov is a website and online database of clinical research studies and information about their results. The website contains both privately and publicly funded clinical studies conducted worldwide. 
• Norwegian Ethics Committees for Clinical Trials on Medicinal Products and Medical Devices (REK KULMU)  
• NorTrials: National partnership between the Regional Health Authorities and the organisations for the pharmaceutical and medical device industries.
• NorCRIN is a Norwegian national research infrastructure body. Its primary objective is to strengthen and simplify collaboration in all categories of clinical research in Norway. It is a partnership consisting of all six university hospitals in Norway. 
• The Association of the Pharmaceutical Industry in Norway (LMI) 
• European Medicines Agency (EMA) 
• Heads of Medicines Agencies (HMA) 
• Lægemiddelsyrelsen – Danish Medicines Agency
• Fimea – Finnish Medicines Agency 
• Läkemedelsverket – Swedish Medical Products Agency