(Updated 12 February 2025)
A) General
A: Yes, in certain cases. Routine GCP inspections usually apply to completed clinical trials and are announced inspections conducted as part of the drug registration application process. If a drug product is seeking drug registration based on Phase 2 trial results (e.g., obtaining accelerated approval by the US FDA), and there is an ongoing Phase 3 trial in Malaysia, the ongoing trial may be selected for inspection to assess compliance with Good Clinical Practice (GCP) and ensure data integrity.
B) Protocol Deviation
Effective from 1st April 2023, to streamline with the amendment on the requirements for Conditional Registration of Pharmaceutical Products During Disaster dated 20th June 2022 (Section 5b: Eligibility Conditions), for Investigational Products (IP) in COVID-19 Trials with the following characteristics can be considered for Fast Track Reviews:
Therapeutic product with new active ingredient(s) and a different mechanism of action or a new vaccine with a different platform that has not been registered in Malaysia (either via full registration or via conditional registration). In addition, the said product should have as good as or compelling efficacy and/or safety profiles compared to current existing registered products.