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Precision Medicine

Advanced Therapies

Genetics and Genomics

International Frameworks

Policies	Guidelines	Other readings
-	IPRP International Regulatory Frameworks for Cell and Gene Therapies 2021 WHO Guidance on Regulatory Framework for Human Cells, Tissues and Advanced Therapy Medicinal Products 2023 ICH Harmonised Guideline on Nonclinical Biodistribution Considerations for Gene Therapy Products S12 2023	ICH Cell and Gene Therapies Discussion Group IPRP Reflection Paper on General Considerations for Raw Materials Used in the Manufacture of Human 2023

Europe

Policies	Guidelines	Other readings
Regulation (EC) No 1394/2007 on Advanced Therapy Medicinal Products Directive 2001/83/EC on the Community code relating to medicinal products for human use	EMA Guidelines Relevant for Advanced Therapy Medicinal Products (various)	EMA HMA Statement on Unregulated Advanced Therapies 2025 MHRA Innovation Office Regenerative Medicine Expert Group

Japan

Policies	Guidelines	Other readings
Pharmaceuticals, Medical Devices, and Other Therapeutic Products Act The Act on the Safety of Regenerative Medicine	Guidelines on Ensuring the Quality and Safety of Gene Therapy Products 2019 Guidelines on Cancer Immunotherapy Development 2019	Guidance on Cancer Immunotherapy Development in Early-phase Clinical Studies 2015 Regulatory Update of Cell and Gene Therapy Products in Japan 2024 Regulatory Update of Regenerative Medicine in Japan 2024 JSRM Yokohama Declaration 2025

Singapore

Policies	Guidelines	Other readings
Health Products Act 2007 Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021	Guidance documents for CTGTP (various) Guidance for Industry Post-marketing Vigilance Requirements for Therapeutic Products and CTGTP 2024 Guidance documents for clinical trials (various)	HSA Cell, Tissue and Gene Therapy Products Classification Tool HSA Cell, Tissue and Gene Therapy Products (CTGTPs) list

United Kingdom

Policies	Guidelines	Other readings
The Human Medicines Regulations 2012 The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 UK Clinical Trials Regulations	Guidance on Advanced Therapy Medicinal Products - Regulation and Licensing in UK Guidance on Clinical Trials for Medicines - Apply for Authorisation in the UK	ABPI Working Group - Clinical Trials Best Practice Guide 2024 Brigden (2024) Regulating ATMPs in the UK After Brexit

United States

Policies	Guidelines	Other readings
21st Century Cures Act Section 3033 (2016) Food, Drug and Cosmetic Act, 21 USC Section 356	Guidance on Expedited Programs for Regenerative Medicine Therapies for Serious Conditions 2019 US FDA Cellular & Gene Therapy Guidances (various) Guidance on Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use 2017	US FDA Approved Cellular and Gene Therapy Products

International Frameworks

Policies	Guidelines	Other readings
-	WHO Human Genome Editing: Recommendations 2021 CPIC Guidelines ICH E15 Definitions for Genomic Biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding categories 2007 Data Privacy Framework for responsible sharing of genomic and health-related data 2019 WHO Guidance on Ethics and Governance of Artificial Intelligence for Health 2021 WMA Declaration of Taipei on Ethical Considerations Regarding Health Databases and Biobanks 2016	WHO Human Genome Editing (HGE) Registry Data Privacy Venne et al. (2020) International Consortium for Personalized Medicine: An International Survey about the Future of Personalized Medicine

China

Policies	Guidelines	Other readings
Implementation Rules for the Management Regulations of Human Genetic Resources 2023 Biosecurity Law of the People's Republic of China 2020 Regulations on Management of Human Genetic Resources 2019 Data Privacy Cybersecurity Law 2016 Personal Information Protection Law 2021	Notice of the Department of Science and Education of the National Health Commission on the release of frequently asked questions on human genetic resources management 2025 Data Privacy Human Genetic Resources Implementation Rules (2023 Guidelines) Technical Standards - Data Security Technology - Rules for Data Classification and Grading	FAQ - Commercialised human cell lines 2025 FAQ - Tumor Xenograft Models 2025 Chinese pharmacogenomics knowledge base (CNPKB) Data Privacy World Economic Forum Insight Report on Precision Medicine and Policy Summit 2018 Navigating China’s Evolving Approach to Human Genetic Resources: Insights on Regulatory Changes China’s Human Genetic Resources Regulation: Key Points for Foreign Stakeholders

Europe

Policies	Guidelines	Other readings
Regulation (EU) 2017/746 on in vitro diagnostic medical devices Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use Data Privacy EU GDPR 2016 Regulation (EU) 2025/327 on the European Health Data Space	Pharmacogenomics EMA Scientific Guidelines on Pharmacogenomics (various) EMA Guideline on good pharmacogenomic practice - First version 2018 EMA Concept paper on predictive biomarker-based assay development in the context of drug development and lifecycle 2017 Data Privacy European Partnership for Personalised Medicine Guidelines for Data Reusability for Personalised Medicine Researchers and Other Stakeholders 2025 EDPB Guidelines 3/2018 on the territorial scope of the GDPR (Article 3) - version adopted after public consultation	EP PerMed Strategic Research & Innovation Agenda for Personalised Medicine 2023 Angers et al. (2018) Overview of EU National Legislation on Genomics Data Privacy Rodríguez-Mejías et al. (2024) Toward the European Health Data Space: The IMPaCT-Data Secure Infrastructure for EHR-based Precision Medicine Research Bernier (2023) Reconciling the Biomedical Data Commons and the GDPR: Three Lessons from the EUCAN ELSI Collaboratory

Japan

Policies	Guidelines	Other readings
Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices 2015 Data Privacy Act on the Protection of Personal Information (2020) Act on Anonymized Medical Data That Are Meant to Contribute to Research and Development in the Medical Field 2017	JCS Guideline on Genetic Testing and Counselling in Cardiovascular Disease 2024 Genetic-Medicine-Related Societies Guidelines for Genetic Testing 2003 Data Privacy The PPC Secretariat Report on Anonymously Processed Information	Koike (2025) The Dawn of a New Era in Genomic Medicine in Japan: The Genome Medicine Promotion Act Uchijo (2023) A new law for promoting genome medicine enacted: Definite provisions for preventing genetic discrimination and mandating the government to formulate a national plan Muto et al. (2023) Is legislation to prevent genetic discrimination necessary in Japan? An overview of the current policies and public attitudes Data Privacy PIPC - Overview of the Amended Personal Information Protection Act 2016

Singapore

Policies	Guidelines	Other readings
Human Biomedical Research Act 2015 Human Biomedical Research (Tissue Banking) Regulations 2019 Moratorium on Genetic Testing and Insurance Data and Privacy Personal Data Protection Act 2012	MOH Guide to the Provision of Non-clinical Genetic Testing 2021 Revised Code of Practice (COP) on the Standards for the Provision of Clinical Genetic/Genomic Testing Services and Clinical Laboratory Genetic/Genomic Testing Services 2021 Competency Framework for the Provision of CGT Services (18 documents) BAC Advisory Report on Genetic Testing and Genetic Research 2005 Data and Privacy BAC Report - Ethical Use of Big Data and Artificial Intelligence in Biomedical Research 2025 PDPC Advisory Guidelines for the Healthcare Sector 2023 Artificial Intelligence in Healthcare Guidelines (AIHGle) 2021	MOH Consultation on Clinical Genetic and Genomic Services 2024 FAQs for the Moratorium FAQs on Competency Framework for the Provision of Clinical Genetic/Genomic Testing (CGT) Services Data and Privacy Trusted Research and Real World Data Utilisation (TRUST) Synapxe HEALIX Cloud-based analytics platform 2024 Use of Real-World Data and Real-World Evidence to Support Drug Reimbursement Decision-Making in Asia Health Information and the National Electronic Health Records Lysaght et al. (2021) Trust and Trade-Offs in Sharing Data for Precision Medicine: A National Survey of Singapore AIGHle Summary of Key Recommendations

United Kingdom

Policies	Guidelines	Other readings
Data Privacy Data Protection Act 2018 The Human Fertilisation and Embryology (Disclosure of Information for Research Purposes) Regulations 2010 The Health Service (Control of Patient Information) Regulations 2002 The Abortion Regulations 1991	Code on Genetic Testing and Insurance 2018 Data Privacy Research Tissue Banks and Research Databases 2025 HRA GDPR Guidance ICO UK GDPR ICO UK GDPR Guidance and Resources Code of Practice on Confidential Information 2014 A Guide to Confidentiality in Health and Social Care 2013 Information Security Management: NHS Code of Practice 2007	NHS-GMSA National rollout of Phase II PROGRESS Pharmacogenomics research study 2025 MHRA and Genomics England - Yellow Card Biobank on how genetic makeup influences the safety of medicines Accelerating genomic medicine in the NHS 2022 UK Science and Technology Committee Report on Direct-to-consumer genomic testing Data Privacy ICO Guidance on Special Category Data

United States

Policies	Guidelines	Other readings
FDA Oversight and Regulation of Laboratory Developed Tests (LDTs) Regulation on Direct-to-Consumer Testing (various) Clinical Laboratory Improvement Amendments (CLIA) Federal Trade Commission Act Data Privacy The Genetic Information Non-discrimination Act of 2008 (GINA) The Health Insurance Portability and Accountability Act of 1996 (HIPPA) HIPAA Privacy Rule - 45 CFR Part 160, Part 164 Subpart A and E HIPAA Security Rule - 45 CFR Part 160, Part 164 Subpart A and C Federal Trade Commission Act - Entities out of HIPAA Scope	FDA Guidance on Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics 2018 FDA Guidance on Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing (NGS) - Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases 2018 Pharmacogenomics FDA Safety Communication Warning for Consumers - Genetic tests that claim to predict patients’ responses to specific medications 2018 FDA Table of Pharmacogenetic Associations Table of Pharmacogenomic Biomarkers in Drug Labelling 2024 Data Privacy Precision Medicine Initiative (PMI) Data Security Principles Implementation Guide 2016 Guidance on HIPAA Privacy Rule in Research	FDA Authorisation of third-party option for conducting reviews on Next-Generation Sequencing Tumor Profiling Tests FDA standardised development criteria for carrier screening and genetic health risk tests USFDA List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) List of FDA-Recognized 510(k) Third Party Review Organizations Policy Statement of the Federal Trade Commission on Biometric Information and Section 5 of the Federal Trade Commission Act 2023 FTC Press Release - Genetic Testing Company 1Health.io Failed to Protect Privacy and Security of DNA Data and Unfairly Changed its Privacy Policy 2023 IAPP Data privacy and genetic testing: Guidance and enforcement from regulators 2024 Data Privacy Precision Medicine Initiative - Data Security Policy Principles Precision Medicine Initiative - Data Security Policy Framework

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