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Resources: For Accreditation - International Addendum

Malaysia Addendum

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Latest Update: October 2, 2020
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Table of Contents

General Comments
Domain 1: Organization
Standard I-1  
Element I.1.A Element I.1.F
Standard I-7

General Comments

The Malaysia Addendum to the Evaluation Instrument for Accreditation is intended for use by organizations in Malaysia seeking accreditation; by site visitors evaluating organizations in Malaysia; and by accredited organizations in the US that conduct or oversee research in Malaysia. This Addendum includes Standards and Elements where Malaysian laws, regulations, and guidelines require significant additional protections beyond those defined in the Evaluation Instrument and is intended to be used in conjunction with the Evaluation Instrument for Accreditation (“Evaluation Instrument”).

The Addendum is based on a review of the following laws, policies, and guidance:

  • A Guide to Conducting Clinical Trials in Malaysia 1st Edition, Society of Clinical Research Professionals Malaysia (2016)
  • Malaysian Guideline for Good Clinical Practice, 4th Ed. (March 2018)
  • Guidelines for Ethical Review of Clinical Research or Research Involving Human Subjects, Ministry of Health Medical Review and Ethics Committee (2006)
  • Malaysian Guideline for Independent Ethics Committee Registration and Inspection (2016)
  • Malaysian Guideline for Application of Clinical Trial Import Licence and Clinical Trial Exemption (Edition 6.4)
  • Malaysian Guideline for Safety Reporting of Investigational Products (2014)
  • Medical Device Act (2012)

The Malaysian Guideline for Good Clinical Practice (“Malaysian GCP”) has the same requirements as ICH-GCP (E6), except where noted below. Organizations that follow the Malaysian GCP should ensure requirements in ICH-GCP (E6) listed in the Evaluation Instrument are included in policies and procedures, as well as the additional requirements from the Malaysia GCP listed below.

Each Malaysia state and territory has separate legislation that may be relevant to the conduct of clinical trials. This Addendum does not include additional requirements under these laws.

This Addendum represents AAHRPP’s current understanding of additional requirements covering organizations conducting or reviewing research in Malaysia.

We appreciate questions, concerns, and suggestions to improve this document. Please email accreditation@aahrpp.org.


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