NPRA Malaysia Issues Updated Guideline for Application of Clinical Trial Import Licence and Clinical Trial Exemption

National Pharmaceutical Regulatory Agency (NPRA) Malaysia has issued an updated guideline on clinical trial import licence (CTIL) and clinical trial exemption (CTX) in September 2021. 

 The updated guideline includes some information on First-in-Human (FIH) studies, and NPRA has decided to accept CTIL and CTX applications for these clinical trials in stages. Currently, only investigational product (IP) involving a new chemical entity and/or herbal or natural product with therapeutic claims will be accepted. Clinical trials that involve testing for generic products and registered traditional (herbal) products with an indication for “traditionally used” when being tested for therapeutic claims are not considered as FIH clinical trials. 

 NPRA has also included the validity period of the CTIL/CTX, which is 3 years from the date of issuance. If the CTIL/CTX is uncollected after 6 months of issuance, the approval will be cancelled unless proper justification can be provided. 

 Regarding the post-approval process, NPRA has now included the steps to be taken if there is a change of investigator or principal investigator (PI) for the clinical trial. The Drug Control Authority (DCA) should be notified, and the documents required are a cover letter with the name of the initial and new investigator or PI listed, the original copy of a declaration by the investigator or PI, GCP certificate of the investigator or PI, CV of the investigator or PI, and a letter of approval from an Independent Ethics Committee / Institutional Review Board or favourable opinion. 

 More details can be found in: 

  • “Malaysian Guideline for Application of Clinical Trial Import Licence and Clinical Trial Exemption, Edition 7.1, September 2021”: 
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