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

On August 2020, the NPRA of Malaysia has updated a document intended to guide the applicant in making Clinical Trial Import Licence (CTIL) and Clinical Trial Exemption CTX) applications to NPRA and reporting to NPRA upon the completion of the clinical trial. Pursuant to Regulation 29, CDCR 1984, no person is allowed to manufacture, supply, sell, import, or administer or possess any product unless the person is a license holder as stipulated in the Regulation or the product is a registered product.

An investigator or an authorized person from a locally registered pharmaceutical company/ sponsor/CRO with a permanent address in Malaysia is allowed to apply for CTIL/CTX.

The guidance document provides a step by step procedure on submitting the documents for the CTIL/CTX application including a requirement to contact officers from the Investigational Product Evaluation and Safety Section (IPESS), Centre of Product and Cosmetic Evaluation (CPCE) to schedule for an appointment to submit the CTIL application in person A flow Chart of the CTIL/CTX application process and CTIL/CTX application process involving the First-in-Human Clinical Trial is included in the document for the applicants.

The Drug Control Authority (DCA) should be informed by the CTIL/CTX holder in case there are any changes in information or any information received by him/her that may cast doubt on the validity of the data which was submitted for the CTIL.

The document also entails information on how the applicants should proceed and engage with the DCA when the trial is completed and communicate with the authorities in the event of early termination of trials.

The Malaysian Guideline for Application of CTIL and CTX 7″ Edition supersedes the previous version of the guidance. This guideline shall also be read in conjunction with other guidelines relevant to the use of investigational products and clinical trial requirements. The current version of this guideline has incorporated (but not limited to) significant amendments regarding CTIL/CTX applications related to first-in-human trials. Adherence to this updated guideline will facilitate the CTIL, CTX, and variation applications leading to timely approval by the Drug Control Authority.

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