Malaysia Compilation of Human Research Standards

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Malaysia Compilation of Human Research Standards

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1. General

   • • A Guide to Conduct Clinical Trials in Malaysia, 2nd edition 2024.pdf

     • Guidelines For Ethical Review Of Clinical Research Or Research Involving Human Subjects.pdf

     • Malaysian Good Clinical Practice (GCP) 5th Edition, 2026.pdf

     • Malaysian Phase I Clinical Trial Guidelines.pdf

     • National Institutes of Health (NIH) Guidelines For Conducting Research In Ministry Of Health Institutions And Facilities 3rd edition 2021,pdf

     • The Malaysian Code of Responsible Conduct In Research 2nd edition.pdf

     • Malaysian Decentralised Clinical Trial (DCT) Guidance Document 2023

2. Drug, Biologics and Devices

   • Guidelines For Ethical Review Of Clinical Research Or Research Involving Human Subjects.pdf

   • Standard Operating Procedure For Transport Of Biological Specimens In.pdf

   • Medical Device Act 2012 (Eng).pdf

   • Medical Device Regulations 2012.pdf

   • Dangerous Drugs Act 1952.pdf

   • MALAYS~1.PDF

   • MALAYS~2.PDF

   • Malaysia National Medicines Policy.pdf

   • Pharmacy Research Priorities in Malaysia.pdf

   • Poisons Act 1952.pdf

   • Sale Of Drugs Act 1952 (REVISED - 1989).pdf

   • Malaysia National Medicines Policy.pdf

   • The Malaysian Guideline for Application of Clinical Trial Import Licence and Clinical Trial Exemption, edition 6.4.pdf

   1. Biologic

   2. Device

   3. Drug

3. Clinical Trial Registries

   • Frequently Asked Questions FAQs by NMRR.pdf

4. Research Injury

   • Act 514 Occupational Safety and Health Act 1994.pdf

   • Malaysian Good Clinical Practice (GCP) 4th Edition.pdf

5. Social-Behavioral Research

   • The Malaysian Code of Responsible Conduct In Research.pdf

6. Privacy Data Protection

   • Compliance to Personal Data Protection Act (PDPA) a quick guide.pdf

   • Malaysian Good Clinical Practice (GCP) 4th Edition.pdf

   • Personal Data Protection (PDPA) Act 2010.pdf

7. Human Biological Materials

   • Act 130 Human Tissues Act (1974).pdf

   • Act 342 Prevention and Control of Infectious Disease Act 1988.pdf

   • Act 699, DNA Identification Act 2009. Malaysian Government Gazette of 3 September 2009.pdf

   • Guideline on the Use of Human Biological Tissues for Research 2016.pdf

   • PREVEN~1.PDF

8. Genetic Research

   • Act 678 Biosafety Act.pdf

   • Biosafety (Approval and Notification) Regulations 2010.pdf

   • Biosafety Guidelines Risk Assessment Of Genetically Modified Microorganisms.pdf

   • Guidelines For Institutional Biosafety Committees.pdf

   • Medical Genetics and Genetic Services MMC Guidelines.pdf

9. Genetic Research Embryos, Stem Cells and Cloning