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Relevant Guidelines and Acts 

Relevant Guidelines and Acts (Click on the title below to download the file)

  1. Malaysian Guideline for Good Clinical Practice 2018

  2. Declaration of Helsinki

  3. Guidance Document and Guidelines for Vaccines Lot Release in Malaysia

  4. Guideline for Stem Cell Research and Therapy

  5. Guidelines for Good Clinical Practice (GCP) Inspection

  6. Guidelines on Good Distribution Practice (GDP)

  7. Malaysian Guideline for Application of Clinical Trial Import Licence and Clinical Trial Exemption

  8. Malaysian Guideline for Bioequivalence Inspection

  9. Malaysian Guideline for Ethics Committee Registration and Inspection

  10. Malaysian Guideline for Safety Reporting of Investigational Products

  11. Malaysian Guidelines on the Use of Human Biological Samples for Research

  12. Medical Device Act 2012

  13. National Guidelines for Haemopoietic Stem Cell Therapy

  14. National Standards for Stem Cell Transplantation - Collection, Processing and Infusion of HSC and Therapeutic Cell

  15. Personal Data Protection Act 2010

  16. Malaysian Guidelines on the Use of Human Biological Samples for Research (2nd Edition)

Malaysia Compilation of Human Research Standards

Malaysia Compilation of Human Research Standards

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  1. General

  2. Drug, Biologics and Devices

    1. Biologic

    2. Device

    3. Drug

  3. Clinical Trial Registries

  4. Research Injury

  5. Social-Behavioral Research

  6. Privacy Data Protection

  7. Human Biological Materials

  8. Genetic Research

  9. Genetic Research Embryos, Stem Cells and Cloning

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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