First Clinical Research Laws, Regulations & Guidelines


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 Armenia – Regulation of the New Drug in Clinical Research 
 Australia – Clinical Trial Handbook 
 Australia – Clinical Trials 
 Australia – Code for the Responsible Conduct of Research 
 Australia – Defence Human Research Ethics Committee – Guidelines for Volunteers 
 Australia – Ethical Conduct in Human Research (2007) 
 Australia – Guide for Aboriginal and Torres Strait Islander Peoples 
 Australia – Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research 
 Australia – Guidelines for Ethical Research in Australian Indigenous Studies 
 Australia – Human Research Ethics Committees 
 Australia – Human Research Ethics Handbook  
 Australia – Human Research in Defence – Instructions for Researchers 
 Australia – National Health and Medical Research Council Regulations 
 Australia – National Health and Medical Research Council Regulations 2006 Explanatory Statement 
 Australia – National Statement on Ethical Conduct (1999) 
 Australia – National Statement on Ethical Conduct in Human Research (2015) 
 Australia – Report of the 1999 Workshops on Ethical Conduct 
 Australia – Revision of NHMRC/AVCC Statement 
 Australia – Therapeutic Goods Act 1989  
 Austria – Clinical Trials on Medicinal Products: Safety Reports to Austrian Ethics Committees 
 Austria – Guidance on Clinical Trial Authorisation & Amendments 
 Austria – Notification of Clinical Investigation with Medical Device or In Vitro Diagnostic 
 Austria – Regulation concerning the specific requirements of ethics committees under multicenter clinical trials 
 Austria – Regulation on Pharmacovigilance Requirements and Pharmacovigilance Reports 
 Austria – The Act on Medical Devices 
 Bangladesh – Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products 
 Belarus – Ministry of Health Decree of 28.03.2008 N 55 
 Belarus – Order 13.08.1999 N 254 on Rules for Conducting Clinical Trials of Medicinal Products 
 Bosnia – Clinical Testing of IMP and Medical Devices 2010 
 Bosnia – The Law on Amendments to the Law on Medicines 
 Brazil – Research Involving New Pharmaceutical Products, Medicines, Vaccines, and Diagnostic Tests 
 Brazil – Resolution 251 
 Brazil – Resolution 292 
 Brazil – Resolution No 196/96 
 Bulgaria – Clinical Trials FAQs 
 Bulgaria – Clinical Trials SOP - Checklist 
 Bulgaria – Clinical Trials SOP2 - Documentation 
 Bulgaria – Clinical Trials SOP 3 - Review and Approval of the Correspondence 
 Bulgaria – Clinical Trials SOP4 – Current Review after Approval 
 Bulgaria – Medicinal Products in Human Medicine Act – Chapter 4 
 Bulgaria – Ordinance No 14 – Clinical Tests of Medicines on People 
 Canada – Canada Tri-Council Policy Statement 
 Canada – CIHR Best Practices for Protecting Privacy in Health Research 
 Canada – Clinical Trial Amendments 1024 
 Canada – Clinical Trials Manual 
 Canada – DAOD 5061-0 Research Involving Human Subjects 
 Canada – Division 5 – Drugs for Clinical Trials 
 Canada – Ethical Conduct for Research Involving Humans 
 Canada – Guidance – Addendum to ICH E11 - Pediatrics 
 Canada – Guidance – Bioavailability Studies (draft) 
 Canada – Guidance – Records Related to Clinical Trials 
 Canada – Guidance for Clinical Trial Sponsors 
 Canada – Guideline - Inclusion of Women 
 Canada – Human Subject Participation in Research Projects: Ethical Considerations 
 Canada – Inspection Strategy 
 Canada – Tri-Council Policy Statement 2010 
 CE Council of Europe – Additional Protocol – Biomedical Research 
 Chile – Law on the Scientific Investigation of The Human Being 
 China – Drug Administration Law 
 China – Good Clinical Practice 
 China – Implementation of the Drug Administration Law 
 China – Notice on the issuance of drug clinical trials, ethical review 
 China – Provisions for Clinical Trials of Medical Devices 
 China – Provisions for Clinical Trials of Medical Devices 
 China – Supervision and Administration of Medical Devices 
 CIS – Model Law on the Protection of Human Rights and Dignity in Biomedical Research 
 Costa Rica – Biomedical Research Regulatory Law 
 Council of Europe – Additional Protocol - Biomedicine 
 Council of Europe – Convention on Human Rights and Biomedicine 
 Croatia – Decision Promulgating the Act on the Amendment to The Medicinal Products Act 
 Croatia – Law on Medical Devices 
 Croatia – Ordinance on Clinical Trials on Medicinal Products and on Good Clinical Practice 
 Croatia – Ordinance on Pharmacovigilance 
 Croatia – The Medicinal Products Act (2013) 
 Czech Republic – Act on Medical Devices 
 Czech Republic –Application for Authorisation/Notification of Clinical Trials 
 Czech Republic – Application for Ethics Committee Opinion on the Conduct of a Clinical Trial in the Czech Republic 
 Czech Republic – Decree of 31 March 2015 Implementing Certain Provisions of The Act on Medical Devices 
 Czech Republic – Documents Required for Authorisation of a Clinical Trial on Pharmaceuticals – Requirements Governing the Pharmaceutical Part of the Dossier 
 Czech Republic – Ethics Committees 
 Czech Republic –Investigator’s Brochure 
 Czech Republic – KLH-8 Clinical trial protocol and protocol amendment(s) 
 Czech Republic – Reporting Adverse Reactions (V4) 
 Czech Republic –Reporting Adverse Reactions to Medicinal Products for Human Use in a Clinical Trial and to Medicinal Products without Marketing Authorisation. 
 Czech Republic –Requirements Governing the Text of Patient Information Leaflet Trial Subject Information Sheet /Informed Consent Form 
 Czech Republic – Terminology and Principles of Good Clinical Practice 
 Declaration of Geneva 
 Denmark – Act on Biomedical Research Ethics Committee System and Processing of Biomedical Research Projects 
 Denmark – Act on Research Ethics Review of Health Research Projects 
 Denmark – Authorisation for Clinical Investigations of Medical Devices 
 Denmark – Clinical Trials – Questions and Answers 
 Denmark – Danish Medicines Act (Consolidated) 
 Denmark – Ministerial Order No 806 – Consent of Trial Subjects 
 Denmark – Reporting of Adverse Reactions, Completion of Trials, etc. 
 Denmark – Research Ethics Committee System (Amendments) 
 EC – Clinical Evaluation: A Guide for Manufacturers and Notified Bodies 
 EC Annex – F2/BL D R1 2003 Annex 13 – Manufacture of Investigational Medicinal Products 
 EC Directive – 2001/83/EC – Medicinal Products 
 EC Directive – 2003/63/EC – Medicinal Products 
 EC Directive – Recommendations for Children (Directive 2001/20/EC) 
 EC EudraLex – Recommendations on Inspections 
 EC Guidance – ENTR/CT2 –Applications to Ethics Committees 
 EC Guidance – Guide for Research Ethics Committee Members 
 EC Guidance – Investigational Medicinal Products 
 EC Guidance – Investigational Medicinal Products (IMPs) and Non Investigational Medicinal Products (NIMPS) (Rev 1) 
 EC Guideline – Serious Adverse Event Reporting for Medical Devices 
 EC Regulation – 540/95 – Reporting Non-Serious Adverse Reactions 
 EC Regulation – Deferral of Pediatric Investigation Plan 
 EC Regulation – EC Regulation on Clinical Trials on Medicinal Products for and Repealing Directive 2001/20/EC 
 EC Regulation – Paediatric Studies 
 EEC Directive – 75/318/EEC – Good Clinical Practice 
 EEC Directive – 75/318/EEC – Pharmacokinetic Studies in Man 
 EFPIA – Disclosure of Transfers of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organisations 
 EMEA – GCP Inspectors Working Group 
 EMEA Guidance – 115735 2004 – EDI of Reports 
 EMEA Guidance – CPMP/EWP/1 776/99 – Missing Data 
 EMEA Guidance – Drug Interactions 
 EMEA Guidance – Investigator Signatures on Clinical Study Reports 
 EMEA Guidance – Multiplicity Issues in Clinical Trials 
 EMEA Guideline – Clinical Trials in Small Populations 
 EMEA Guideline – Compassionate Use of Medicinal Products 
 EMEA Guideline – Data Monitoring Committees 
 EMEA Guideline – First-in-Man High-Risk Medicinal Trials (Draft) 
 EMEA Guideline – Mitigating Risks in First-In-Human Trials 
 EMEA Paper – Healthrelated Quality of Life (HRQL) Measures 
 England – Good Research Practice: Principles and Guidelines (2012) 
 England – MRC Research Involving Human Participants in Developing Societies (2004) 
 Estonia – Medical Products Act 
 Estonia – National Regulations on Ethics and Research 
 Estonia – Regulation 17 - Rules of Procedure of Medical Ethics Committee 
 Estonia – Regulation 23 - Conducting Clinical Trials 
 Estonia – Regulation 26 - Reporting Serious Adverse Events 
 Estonia – Rules for Medical Ethics Committee for Clinical Trials 
 EU – Clinical Trials on Medicinal Products for Human Use and Repealing Directive 2001/20/EC 
 EU – Data Protection and Privacy Ethical Guidelines 
 EU – Ethical Considerations with the Paediatric Population 
 EU – Ethics Reviews 
 EU – Guidance for Informed Consent 
 EU – Guideline on Good Pharmacovigilance Practices 
 EU – Regulation No 536/2014 – Clinical Trials on Medicinal Products 
 EU – Regulation No 536/2014 of 16 April 2014 on clinical trials and repealing Directive 2001/20/EC 
 EU – Volume 4 Annex 13 R1 - Manufacture of Investigational Medicinal Products 
 EU Council of Europe Recommendation R (97) 5 – Protection of Medical Data 
  EU Decision 1982/2006/EC – Seventh Framework Programme 
 EU Directive 93/42/EEC – Medical Devices 
 EU Directive 95/46/EC – Protection of Personal Data 
 EU Directive 2001/20/EC – Good Clinical Practice 
 EU Directive 2001/83/EC – Committee for Proprietary Medicinal Products 
 EU Directive 2002/58/EC – Privacy and Electronic Communications 
 EU Directive 2003/94/EC – Good Manufacturing Practice 
 EU Directive 2004/27/EC – Medicinal Products 
 EU Directive 2005/28/EC – Good Clinical Practice 
 EU Directive 2007/47/EC – Active Implantable Medical Devices & Biocidal Products 
 EU European Commission – Research Ethics in Developing Countries 
 EU Group on Ethics – Ethical Aspects of Clinical Research in Developing Countries 
 EU Guidance – Clinical Trials Q&A (version 8.0) 
 EU Guidance – Medicinal Product Definitions 
 EU Guidance CT1 (R1) – Regulatory Framework 
 EU Guidance CT1 (R2) – Request for Authorisation 
 EU Guidance CT2 (R1) – Clinical Trial Application Format 
 EU Guidance CT3 (R2) – Adverse Reaction Reports 
 EU Guidance CT4 (R1) – SUSAR 
 EU Guidance CT 5.1 – EUDRACT 
 EU Guidance F2/BL D (2006) – Clinical Trial Documents Q&A 
 EU Guideline F/2 D (2002) – Qualifications of Inspectors (Draft) 
 EU Guideline F/2 D 2002 – Inspection Procedures (Draft) 
 EU Guideline MEDDEV. 2.7.1 Rev.3 – Medical Devices Clinical Evaluation 
 Finland – Clinical Investigations on Medical Devices 
 Finland – Clinical Trials on Medicinal Products 
 Finland – Decree of the Ministry of Social Affairs and Health on Clinical Drug Trials 
 Finland – Medical Research Act (Amended) 
 Finland – Medical Research Act 1999  
 Finland – Medical Research Decree (Amended) 
 Finland – Perspectives on Medical Research Conducted on Children 
 Ghana – Guidelines for Authorization of Clinical Trials of Medicines, Food Supplements, Vaccines and Medical Devices 
 Ghana – Guidelines for Conduct of Clinical Trials during Emergencies 
 Ghana – Guidelines for Conduct of Clinical Trials in Paediatric Population 
 Ghana – Guidelines for Good Clinical Practice in Ghana 
 Greece – Guide for Research Ethics Committees 
 Hungary – Act XCV of 2005 on Medicinal Products for Human Use and on the Amendment of Other Regulations Related to Medicinal Products 
 Hungary – Clinical Trial and Clinical Practice of Investigational Medical Products 
 Hungary – Decree 24/200 
 Hungary – National Regulations on Ethics and Research 
 Iceland – Act on Scientific Research in the Health Sector  
 Iceland – Regulation on Clinical Trials 
 Iceland – Regulation on Clinical Trials of Medicinal Products in Humans as Amended by Regulations No. 907/2004 and No. 1099/2010 
 Iceland – Regulations on Scientific Research in the Biomedical Field 
 Iceland – Scientific Research in the Health Sector 
 ICH – E17 General Principles for Planning and Design of Multi-Regional Clinical Trials 
 India – Drug & Cosmetics Laws (extracts) 
 India – Drugs & Cosmetics Act (Amended 2005, Excerpts) 
 India – Ethical Guidelines for Biomedical Research on Human Participants 
 India – GCP Guidelines 
 India – Good Clinical Practices Guidelines 2004 
 India – Guidelines for Preparing SOPs for Institutional Ethics Committee for Human Research 
 Indonesia – Indonesian Health Act No. 23/1992 Part 7 
 International Code of Medical Ethics (Amended 1983) 
 Ireland – Clinical Trial Regulations 
 Ireland – Control of Clinical Trials Act 1987 
 Ireland – Control of Clinical Trials Act 1990 
 Ireland – Guidance on Operational Procedures for Research Ethics Committees 
 Ireland – Guide for Ethics Committees on Clinical Investigation of Medical Devices 
 Ireland – S.I. No. 190/2004 – Clinical Trial Regulations 
 Israel – Guidelines for Clinical Trials 
 Italy – Conduct of Clinical Trials 
 Italy – Legislative Decree 211 (2001/20/EC) 
 Jamaica – Guidelines for the Conduct of Research on Human Subjects 
 Japan – Ethical Guidelines for Epidemiological Research 
 Japan – Ministerial Ordinance on Good Clinical Practice for Drugs 
 Japan – Ministerial Ordinance on Good Clinical Practice for Medical Devices 
 Japan – Practical Operations of Electronic Study Data Submissions 
 Korea – Enforcement Regulations of the Medical Device Act Articles 12-13 
 Korea – Guidance on Phase I Clinical Trial in Healthy Subjects 
 Korea – Pharmaceutical Affairs Act Article 34 
 Korea – Regulation on Approval for Investigational New Drug Application 
 Kuwait – Ethical Guidelines for Biomedical Research 
 Latvia – National Regulations on Ethics and Research 
 Latvia – Procedures for the Clinical Trial of Medical Devices Intended for Human Use 
 Latvia – Regulations on Clinical Trials 
 Lithuania – Amendments to Law on Ethics of Biomedical Research 
 Lithuania – Law on Ethics of Biomedical Research 
 Macedonia – Law on Medicinal Products and Medical Devices III.2 
 Malawi – General Guidelines on Health Research 
 Malaysia – Guidelines for Good Clinical Practice 
 Malaysia – Guidelines to Conduct Clinical Trials 
 Malta – Clinical Trials Regulations 
 Malta – Good Clinical Practice and Requirements for Manufacturing or Import Authorisation of Investigational Medicinal Products  
 Malta – Medicines Act 2003 
 Malta – National Regulations on Ethics and Research 
 Mexico – National Guidelines for Integration and Operation of the Research Ethics Committee 
 Mexico – Standard NOM-012-SSA3-2012, Implementation of Projects of Research for Health in Humans 
 Montenegro – Law on Medicinal Products, Articles 36-49 
 Netherlands – Clinical Research with Medicinal Products 
 Netherlands – External Review Directive 
 Netherlands – External Review Directive Explanatory Notes 
 Netherlands – Medical Research (Human Subjects) Act 
 Netherlands – Medical Research Act 
 New Zealand – Ethical Guidelines for Intervention Studies 
 New Zealand – Ethical Guidelines for Intervention Studies (2012) 
 New Zealand – Guideline on the Regulation of Therapeutic Products Part 11 
 New Zealand – Guidelines for Researchers on Health Research Involving Maori 
 New Zealand – Medicines Code of Practice 
 New Zealand – SOPs for Health and Disability Ethics Committees 
 Nigeria – Good Clinical Practice Regulations (2009) 
 Nigeria – National Code of Health Research Ethics 
 Norway – Guidelines for Research Ethics 
 Norway – Regulation Relating to Clinical Trials 
 Nuremberg Code 
 PAHO – Good Clinical Practices: Document of the Americas 
 Pakistan – Guidance Document to Help Researcher Fill the ERC Application Form 
 Philippines – Introduction to Health Research Ethics  
 Philippines – National Ethical Guidelines for Health Research 
 Philippines – Recognition of Ethical Review Board/Committee (ERB/ERC) for Clinical Trials on Investigational Medicinal Products 
 Poland – Regulations on Ethics and Research 
 Qatar – Guidelines, Regulations and Policies for Research Involving Human Subjects 
 Republic of Moldova – Law on Medicines Chapter 3 
 Republic of Rwanda – Health Sector Research Policy 
 Romania – 906/2006 – Testing Medical Products – General Principles 
 Romania – 906/2006 – Testing Medicinal Products 
 Romania – Good Clinical Practice (anexa_OMSP_904_2006) 
 Romania – Order on Good Clinical Practice (OMSP 904 2006) 
 Romania – Regulations on Ethics and Research 
 Romania – Testing of Medical Products – Annex 
 Russia – Clinico-Economic Studies 
 Russia – Russian Federation Federal Law on Medicinal Products 
 Saudi Arabia – Implementing Regulations of the Law of Ethics of Research on Living Creatures 
 Saudi Arabia – The Law of Ethics of Research on Living Creatures 
 Scotland –Adults with Incapacity (Ethics Committee) Regulations (2002) 
 Scotland – Adults with Incapacity Act, Section 51 
 Scotland – Research Governance Framework 
 Serbia – Regulation on Clinical Testing of Medicinal Products, Documentation for Authorising 
 Singapore – Clinical Evaluation Study Group 5 
 Singapore – Clinical Evidence Key Definitions and Concepts 
 Singapore – Introduction to Clinical Trials: Questions and Answers 
 Singapore – Medicines (Clinical Trials) Regulations 
 Singapore – Research Involving Human Subjects: Guidelines for IRBs 
 Slovak Republic – Regulations on Ethics and Research 
 Slovenia – Medicinal Products Act Articles 33-40 
 Slovenia – Regulations on Ethics and Research 
 South Africa – Ethics in Health Research: Principles, Structures and Processes 
 South Africa – Human Sciences Research Council Act 
 South Africa – Medical Research Council Act 
 South Africa – Regulations Relating to Research with Human Participants 
 Spain – Law on Biomedical Research 
 Spain – Order SCO / 256/2007 good clinical practice and manufacture or importation of investigational medicinal products for human use 
 Spain –Personal Data Protection in Clinical Research and Pharmacovigilance 
 Spain – Pharmacovigilance of Medicinal Products for Human Use 
 Spain – Royal Decree 1090/2015 Clinical trials with medicinal products, Ethics Committees, and the Spanish Clinical Studies Registry 
 Sudan – Guidelines for Ethical Conduct of Research Involving Human Subjects 
 Sweden – Background and Regulations 
 Sweden – Central Ethical Review Boards 
 Sweden - Ethical Review of Research 
 Sweden – Ethical Review of Research 
 Sweden – Ethical Vetting of Research 
 Sweden – Ethical Vetting of Research 
 Sweden – Provisions and Guidelines 
 Sweden – Regional Ethical Review Boards 
 Sweden – Statute (2007:1068): Instructions for the Central Ethical Review Board 
 Sweden – Statute: Instructions for Regional Ethical Review Boards (2007:1069) 
 Sweden – Trials of Medicinal Products for Human Use 
 Sweden – What is Subject to Review? 
 Switzerland – Clinical Trials of Medical Devices 
 Switzerland – Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA) Chapter 4, Section 2 
 Switzerland – Federal Act on Research involving Human Beings (810.30) 
 Switzerland – Federal Act on Research involving Human Beings (Human Research Act, HRA) 
 Switzerland – Guide to the Regulation of Medical Devices  
 Switzerland – Ordinance on Clinical Trials (812.214.2) 
 Switzerland – Ordinance on Clinical Trials in Human Research (810.305) 
 Switzerland –Ordinance on Organisational Aspects of the Human Research Act (810.308) 
 Taiwan – Human Subjects Research Act 
 Taiwan –Organization and Management of the Institutional Review Board 
 Taiwan – Regulations on Human Trials 
 Tanzania – Guidelines of Ethics for Health Research in Tanzania 
 Tanzania – NIMR Research Policy, Guidelines and Regulations 
 Tanzania – SOPs for the National Health Research Ethics Review Committee 
 Thailand – Ethical Guidelines for Research on Human Subject 
 Thailand – National Policy and Guidelines for Human Research 
 Turkey – Good Clinical Practice 
 Turkey – Guidance on Ethical Approaches for Clinical Trials Conducted with the Pediatric Population 
 Turkey – Guideline on Reports of Adverse Events/Reactions Occurring in Clinical Drug Trials 
 Turkey – Regulation on Clinical Trials 
 Turkey – Regulations on Drug Research 
 Turkey – Regulation to Amend the Regulation on Clinical Trials 
 Uganda –Guidelines for Research involving Humans 
 UK – Clinical Trials Amendments (2006/1928) 
 UK – Clinical Trials Regulations (2004/1031) 
 UK – Clinical Trials Regulations (2006/2984) 
 UK – Consultation Letter on The Medicines for Human Use (Clinical Trials) Regulations (2003) 
 UK – Data Monitoring Committees in Clinical Trials 
 UK – Fees and Charges (2004/1157) 
 UK – Governance Arrangements for Research Ethics Committees 
 UK – Guidelines for Phase 1 Clinical Trials 
 UK – mCTA Clinical Trial Agreement 
 UK – mCTA Guidance on Model Clinical Trial Agreement Guidance 
 UK – mCTA Tripartite Clinical Trial Agreement (CROs) 
 UK – mCTA Tripartite Model Clinical Trial Agreement (CROs) Guidance 
 UK – Medicines for Human Use (Clinical Trials) and Blood Safety and Quality (Amendment) Regulations (2008) 
 UK - Medicines for Human Use (Clinical Trials) Regulations 2004 
 UK – Mental Capacity Act – Explanatory Memo (2006/3474) 
 UK – MOU on Clinical Trials Regulations 2004 
 UK – Report of the Working Party on Statistical Issues in First-in-Man Studies 
 UK – Research Governance Framework for Health and Social Care 
 Ukraine – Procedure for Conducting Clinical Trials and Expert Evaluation of Materials 
 UNAIDS – Ethical considerations in HIV preventive vaccine research 
 UNAIDS – HIV Preventive Vaccine Research Ethics 
 UNESCO – Universal Declaration on Bioethics and Human Rights 
 Vietnam – Guidelines for Clinical Trials on Drugs  
 Vietnam – Regulations on Research Support Activities for Clinical Trials 
 WHO – Clinical Safety Data Management 
 WHO – Ethical Considerations in Biomedical HIV Prevention Trials 
 WHO – Ethical issues in Patient Safety Research  
 WHO – Guidance – Handbook for Good Clinical Research Practice (GCP) Handbook for Good Clinical Practice (GCP) 
 WHO – Guidance for Ethics Review of Health-Related Research with Human Participants 
 WHO – Guideline TDR/PRD/Ethics/2000.1 – Ethics Committees 
 WHO – SOPs for Clinical Investigators 
 WMA – Declaration of Helsinki (2003) – Workgroup Report on the Revision of Paragraph 30 
 WMA – Declaration of Helsinki (2004) 
 WMA – Declaration of Helsinki (2008) 
 WMA – Declaration of Helsinki (2008) – Reasons for Changes (Draft) 
 WMA – Declaration of Helsinki (2013) 
 WMA – Medical Ethics Manual 
 WMA – Statement on Conflict of Interest 
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