Medicines Act (Chapter 176): Primary legislation governing the manufacture, import, supply, presentation and advertisement of medicinal products in Singapore
Health Products Act: Regulatory framework for health products, including medical devices and therapeutic products used in clinical trials
Human Biomedical Research Act 2015: Legislation regulating human biomedical research, ensuring appropriate safeguards for research subjects and proper conduct of clinical trials
Personal Data Protection Act 2012: Framework for data protection and privacy, governing collection, use, disclosure and care of personal data in clinical trials
Singapore Guideline for Good Clinical Practice: Local adaptation of international GCP guidelines, providing standards for designing, conducting, recording, and reporting clinical trials
HSA Clinical Trial Guidance: Regulatory guidance from Health Sciences Authority covering trial authorization, safety reporting, and compliance requirements
MOH Clinical Trials Regulations: Ministry of Health guidelines governing the conduct of clinical trials in healthcare institutions
Clinical Trial Authorization Requirements: Specific requirements for obtaining Clinical Trial Certificates (CTC) or submitting Clinical Trial Notifications (CTN)
Ethics and Safety Framework: Requirements for IRB approval, safety reporting protocols, and subject protection measures in clinical trials
Data Protection Requirements: Specific protocols for data storage, transfer, and international sharing in compliance with PDPA
Informed Consent Framework: Standards for obtaining and documenting informed consent, including subject rights and protections under HBRA
Contract Legal Requirements: Singapore law requirements for liability, indemnification, intellectual property rights, and dispute resolution in clinical trial agreements
Financial Compliance Framework: Regulations governing payment terms, research funding, and tax implications for clinical trials in Singapore
