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Malaysia Compilation of Human Research Standards
Guidelines and Guide Documents

(Click on the title below to download the file)

Ministry of Health (MOH), National Pharmaceutical Regulatory Agency (NPRA)

  1. NIH Guidelines for Conducting Research in Ministry of Health Institutions & Facilities 3rd Edition (2021)

  2. ​Malaysian Guidelines for Good Clinical Practice (GCP) Inspection, 3rd edition, 2026

  3. Malaysian Guideline for Application of Clinical Trial Import Licence (CTIL) and Clinical Trial Exemption (CTX) 8.1th Edition

  4. Malaysian Guidelines on the Use of Human Biological Samples for Research, 2nd Edition, 2025

  5. Malaysian Guideline for Bioequivalence Inspection 2nd Edition, 2024

  6. Malaysian Guideline for Independent Ethics Committee Registration and Inspection, First Edition, 2014

  7. Guidelines On Stem Cell And Cell-Based Research And Therapy 3rd Edition 2024

  8. Guideline on Good Distribution Practice 3rd Edition, 2018

  9. Guidelines on Ethical Issues in the Provision of Medical Genetics Services in Malaysia, 2019

  10. Guideline for Herbal Medicine Research, 2023

  11. Guidelines for the Safe Transport of Clinical Specimens and Infectious Substances in Malaysia, 2023 (replacing Standard Operating Procedure for Transport of Biological Specimens)

  12. Guidance Document for Biological Lot Release in Malaysia, 2025 (Guidance Document and Guidelines for Vaccines Lot Release in Malaysia has been included in this guidance since 2019)

 

​Local Professional Bodies​

  1. Malaysian Phase I Clinical Trial Guidelines, 2017 (CRM).pdf

  2. Malaysian Decentralised Clinical Trial (DCT) Guidance Document, 2023 (CRM)

  3. A Guide to Conducting Clinical Trials in Malaysia, 2nd Edition, 2024 (SCRPM)

  4. MMC Medical Genetics and Genetic Services, 2006

  5. MMC Stem Cell Research & Stem Cell Therapy, 2009

  6. MMA Code of Ethics 2023 edition

  7. MMC Clinical Trial & Biomedical Research, 2006

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​Science, Technology & Innovation

  1. The National Guidelines on AI Governance & Ethics, 2024

  2. Garis Panduan Etika Bioteknologi di Malaysia, 2025​​

Relevant Guide Documents for Sub-Specialty Research

(Click on the title below to download the file)

​​Stem cell research

  1. ISSCR Guidelines for Stem Cell Research and Clinical Translation, v1.2, 2025 August

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Genomic Research / Data-intensive Research

GA4GH’s standards:

  1. Consent Policy (v2.0, 2019)

  2. Data Privacy and Security Policy (v2.0, 2019)

  3. Framework for Involving and Engaging Participants, Patients, and Publics in Genomics Research and Health Implementation (v1.0, 2021)

  4. Ethics Review Recognition Policy (v2.0, 2020)

  5. Framework for responsible sharing of genomic and health-related data sharing (v1.0, 2019)

  6. Machine-Readable Consent Guidance (v1.0, 2023)

  7. Policy on Clinically Actionable Genomic Research Results (v1.0, 2021)

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Public Health Emergencies (including human-controlled infection)

  1. WHO Key criteria for the ethical acceptability of controlled human infection studies during public health emergencies, 2025

  2. WHO Emergency use of unproven clinical interventions outside clinical trials: ethical considerations, 2025

  3. WHO guidance on the ethical conduct of controlled human infection studies, 2021

  4. WHO Guidance for research ethics committees for rapid review of research during public health emergencies, 2020

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Artificial Intelligence

  1. WHO Ethics and governance of artificial intelligence for health, 2021

  2. WHO Ethics and governance of artificial intelligence for health: Guidance on large multi-modal models, 2024

  3. WHO Benefits and risks of using artificial intelligence for pharmaceutical development and delivery, 2024

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Other type of research

  1. WHO Guidance on ethical considerations in planning and reviewing research studies on sexual and reproductive health in adolescents, 2018

  2. WHO Ethics in implementation research: facilitator's guide, 2019

  3. WHO Ethics in implementation research: participant's guide, 2019

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UMMC-Medical Research Ethics Committee

Tel. +603 7949 3209 / 2251 / 8473 / 4656

Email.ummc-mrec@ummc.edu.my

3rd floor, Menara Utama, Pusat Perubatan Universiti Malaya 59100 Kuala Lumpur, Malaysia

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