“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:
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