Legislation and guidelines regarding clinical trials of human medicines

EudraLex Volume 10 of the publication "The rules governing medicinal products in the European Union" 

Clinical trials of medicinal products for human use are primarily regulated by the common European legislation, Regulation (EU) No. 536/2014. This regulation replaces Directive 2001/20/EC. 

EudraLex Volume 10 contains all guidance documents and links to legislation relevant to clinical studies in the EU/EEA. Several documents in this volume have undergone updates and revisions to align with the requirements of the Regulation. New documents have also been created to address the novel elements introduced by this Regulation. 

 To differentiate between documents that apply to clinical trials authorised under Directive 2001/20/EC and those authorised under Regulation (EU) No 536/2014, they have been organised into two distinct pages. 

For the duration of the transition period (ends 30th of January 2025), both sets of legislations will be available. 

Regulation

• Regulation for clinical trials of medicinal products for humans: Regulation (EU) No. 536/2014 
• 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 (see information over).

National legislation 

• National legislation (in Norwegian only): Forskrift om klinisk utprøving på legemidler til mennesker 
• National legislation (in Norwegian only): Legemiddelforskriften Forskrift om legemidler til mennesker 

Scientific Guidelines 

• ICH E6 (R2) Good Clinical Practice: This guide provides an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects  
• ICH M3 (R2) Non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals: 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: 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:  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:  This guidance addresses the specific documentation requirements on the biological, chemical and pharmaceutical quality of investigational medicinal product (IMP) containing biological/biotechnology derived substances. 

Relevant Guidelines 

• WMA Declaration of Helsinki - Ethical principles for medical research involving human subjects
• 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
• Guidance document: Recommendations related to contraception and pregnancy testing in clinical trials (the document is available on CTCGs website under “Key documents list”)

National links 

• Norwegian Ethics Committees for Clinical Trials on Medicinal Products and Medical Devices (REK KULMU)  
• Regional Committees for Medical and Health Research Ethics (REK) 
• 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 a partnership consisting of all six university hospitals in Norway. 
• The Association of the Pharmaceutical Industry in Norway (LMI) 
• NorTrials: National partnership between the Regional Health Authorities and the organisations for the pharmaceutical and medical device industries.

Relevant Agencies and Working Groups 

• European Medicines Agency (EMA) 
• Heads of Medicines Agencies (HMA) 
• Lægemiddelsyrelsen – Danish Medicines Agency 
• Fimea – Finnish Medicines Agency 
• Läkemedelsverket – Swedish Medical Products Agency 
• Heads of Medicines Agencies: Clinical Trials Coordination Group (hma.eu)  
• Clinical Trials Coordination Group (CTCG) is a working group of experts in the classification, assessment and oversight of clinical trials from National Agencies. 
• 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. 

Relevant portals and databases for clinical trials 

• 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  
• 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.