Malaysia NPRA Updates Guideline for Application of Clinical Trial Import License (CTIL) and Clinical Trial Exemption (CTX)

Malaysia NPRA has revised the Malaysian Guideline for Application of Clinical Trial Import License (CTIL) and Clinical Trial Exemption (CTX) Edition 8.0, slated for publication on April 30, 2024.

This decision stems from the Drug Control Authority agrees that there is a need to unify Malaysian Guideline for Application of CTIL and CTX and the Malaysian Guideline for Safety Reporting of Investigational Product so that applicants only need to refer to one guideline to obtain information related to the application of CTIL/CTX and the requirement of safety reporting.  NPRA also revised the guideline with improvement of the CTIL/CTX application process and variation application.

Key changes are:

1. Incorporation of Safety Reporting into CTIL/CTX guideline.
2. Updates on variation applications:
    a) Reintroduction of variation for change of investigator.
    b) Removal of variation for additional quantities for the new protocol.
    c) Addition of variation for change of name and address of the applicant’s company
3. First in human (FIH) definition & process flow reengineering
4. Introduction of Appendix G2 Format for Manufacturing Drug Accountability Report
5. Introduction of new payment form

The updated guidance is available at the following link: https://www.npra.gov.my/easyarticles/images/users/1140/Malaysian-Guideline-for-Application-of-CTIL-and-CTX-8th-Ed-Final.pdf

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