Index
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Worldwide
An useful document is the International Compilation of Human Research Standards. It contains an overview of laws, regulations and guidelines from more than 100 countries and organisations.
Africa
Kenia
Nigeria
South Africa
- Medicines Control Council (MCC)
- South African Health Products Regulatory Authority (SAHPRA)
- South African Medical Research Council (SAMRC)
- South African National Clinical Trials Register (SANCTR)
Please use the “Contact” form to report broken links, outdated information and missing webpages.
Asia
Japan
Singapore
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Australia
Australia
New Zealand
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Europe
European Union (EU/EEA)
Authorities & organisations
- Council of Europe
- EU Science Hub
- European Centre for Disease Prevention and Control (ECDC)
- European Commission (EC)
- European Council
- European Data Protection Board (EDPB)
- Guidance
- Statements
- European Data Protection Supervisor (EDPS)
- European network of paediatric research at the European Medicines Agency (Enpr-EMA)
- European Medicines Agency (EMA)
- Brexit: the United Kingdom’s withdrawal from the European Union
- Clinical Data Publication
- COVID-19
- Clinical Trial Regulation
- Conditional marketing authorisation
- Paediatric investigation plans
- Q&A: Good clinical practice (GCP)
- European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)
- Heads of Medicines Agencies
Data Protection
- Directives & Regulations
- Guidance documents
- EDPB
- GDPR: Guidelines, Recommendations, Best Practices
- Guidance
- Statements
- Other documents
- GDPR: Guidelines, Recommendations, Best Practices
- EDPB
- Other informative documents
Funding
Genetically modified organism (GMO)
Investigational medicinal products
- Directives & Regulations
- ECTD: Directive 2001/20/EC OF the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
- ECTR: Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
- Guidance documents
- Mandatory clinical trial registration
- Pharmacoepidemiological study register
Medical devices & In Vitro Diagnostic Medical Devices
- Directives & Regulations
- MDD: Council Directive 93/42/EEC on Medical Devices (MDD)
- IVDMD: Directive 98/79/EC of the European Parliament and of the Council on in vitro Diagnostic Medical Devices (IVDMD)
- AIMDD: Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD)
- MDR: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
- IVDR: Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
- Guidance documents
- Other information
Organisations
- All European Academies (ALLEA)
- Association of European-level Research Infrastructure Facilities (ERF-AISBL)
- BBMRI-ERIC (European research infrastructure for biobanking)
- CEN CENELEC
- European Bioinformatics Institute (EMBL-EBI)
- European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)
- EUDAT Collaborative Data Infrastructure (EUDAT CDI)
- European Federation of Pharmaceutical Industries and Associations (EFPIA)
- European Forum for Good Clinical Practice (EFGCP)
- European Clinical Research Infrastructrure Network (ECRIN)
- ECRIN Tools Overview
- COVID-19
- European Research Infrastructures against COVID-19
- COVID-19 Taskforce.
- COVID-19 Trials registries
- Regulatory – ethical considerations for ongoing trials during Pandemic
- Fast track procedure for COVID 19 Clinical trials.
- Clinical Research Metadata Repository
- COVID-19 Literature reviews
- Other COVID-19 resources
- European CRO Federation (EUCROF)
- European Life Science Research Infrastructures (LS RI)
- European Network for Health Technology Assessment (EUnetHTA)
- European Network of Research Ethics and Research Integrity (ENERI)
- European Network of Research Ethics Committees (EUREC)
- European Network of Research Integrity Offices (ENRIO)
- European Organisation for Research and Treatment of Cancer (EORTC)
- European Patients’ Academy on Therapeutic Innovation (EUPATI)
- European Strategy Forum on Research Infrastructures (ESFRI)
- European Quality Assurance Confederation (EQAC)
Please use the “Contact” form to report broken links, outdated information and missing webpages.
Austria
- Austrian Federal Ministry of Education, Science and Research (BMBWF)
- Austrian Federal Office for Safety in Health Care (BASG)
Belgium
Bulgaria
Czech Republic
Croatia
Cyprus
Denmark
Estonia
Finland
France
- Authorities
- Organisations
Germany
- Authorities
- Organisations
Greece
Hungary
Ireland
Italy
Latvia
Malta
Netherlands
Poland
- Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL)
- Naczelna Izba Lekarska (NIL)
- The Employers’ Union of Innovative Pharmaceutical Companies (INFARMA)
- Polish Association of Clinical Research Organizations (POLCRO)
- Polish Association of Good Clinical Practice (GCPpl)
Portugal
Romania
Slovakia
Slovenia
- Javna agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP) / Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
Spain
Sweden
Switzerland
United Kingdom (UK)
- Research Application System
- Autorities
- Human Tissue Authority (UK)
- Information Commissioner’s Office
- Medicines & Healthcare products Regulatory Agency (MHRA)
- Medicines, medical devices and blood regulation and safety: detailed information
- Clinical trials and investigations: detailed information
- Manufacturing, wholesaling, importing and exporting medicines
- Vigilance, safety alerts and guidance: detailed information
- Medicines, medical devices and blood regulation and safety: detailed information
- National Institute for Health and Care Excellence (NICE)
- NHS Health Research Authority (HRA)
- Funding
- Guidance
- Organisations
Please use the “Contact” form to report broken links, outdated information and missing webpages.
North America
United States of America
- Authorities & organisations
- Centers for Disease Control and Prevention (CDC)
- National Academy of Sciences, Engineering, and Medicine
- National Institutes of Health (NIH)
- U.S. Department of Health & Human Services (HHS)
- U.S. Food and Drug Administration (FDA)
- Clinical Trials Guidance Documents
- FDA’s MyStudies Application (App)
- Guidance
- Information Sheet Guidance for Institutional Review Boards (IRBs), Clinical Investigators, and Sponsors
- COVID-19
- Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic
- Guidance for Industry on Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency
- Guidance for Industry: Development and Licensure of Vaccines to Prevent COVID-19 (June 2020).
- Guidance for Industry – COVID-19: Developing Drugs and Biological Products for Treatment or Prevention
- Guidance for Industry – Investigational COVID-19 Convalescent Plasma
- Recommendations for Investigational COVID-19 Convalescent Plasma.
- Guidance Documents (Including Information Sheets) and Notices
- Investigational New Drug (IND) Application (FDA)
- Regulatory Information: Search for FDA Guidance Documents
- Newly Added Guidance Documents
- Clinical trial registration
- Regulations
- Medical associations and organizations
- American Board of Radiology (ABR)
- American College of Physicians (ACP)
- American College of Radiology (ACR)
- American Lung Association
- American Medical Association (AMA)
- American Public Health Association (APHA)
- American Roentgen Ray Society (ARRS)
- American Society of Clinical Oncology (ASCO)
- American Society of Radiologic Technologists (ASRT)
- National Academy of Medicine
- Radiological Society of North America (RSNA)
Please use the “Contact” form to report broken links, outdated information and missing webpages.
South America
Argentina
Brazil
Colombia
Chile
Peru
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