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Malaysian Guideline for Application of Clinical Trial Import Licence (CTIL) & Clinical Trial Exemption (CTX)

Malaysia's National Pharmaceutical Regulatory Agency (NPRA) released an updated guideline on "Guideline for Application of Clinical Trial Import Licence (CTIL) & Clinical Trial Exemption (CTX)" that is intended to assist the applicant in making a CTIL/CTX application to the NPRA and reporting to the NPRA during and at the end of a clinical trial.


Clinical Trial Exemption is an exemption issued that exempts a person who wishes to manufacture product(s) solely for the purpose of producing samples for clinical trials.


Clinical Trial Import Licence is a licence which authorises the licensee to import any product for the purposes of clinical trials, not withstanding that the product is not a registered product.


For a clinical trial involving products that require CTIL/CTX, the trial cannot commence until the ethics committee (EC) issues a favourable opinion and the CTIL/CTX application is approved by the NPRA.


All clinical trials requiring CTIL/CTX must be registered with the National Medical Research Register (NMRR) and For clinical trials that involve healthy volunteers, it is the responsibility of the sponsor or applicant to register the healthy volunteers in the NHRVR database as per the directive of DPS CTI-2021.


The guidance states that it is necessary to obtain CTIL/CTX before commencing a clinical study involving an unregistered product (or products) that require CTIL/CTX, and before importing or manufacturing the product locally. The following products require a CTIL/CTX:

  1. An unregistered product, including a placebo, imported/manufactured locally for the clinical trial.

  2. A product with a marketing authorisation when assembled (formulated or packaged) in a way different from the approved form; AND when used for unapproved indication or when used to gain further information about an approved use, for clinical trial purposes.

  3. A traditional product with a marketing authorisation with an indication for "traditionally used", when used for an unapproved therapeutic claim in a clinical trial.

The applicant is responsible for the product and all information provided in support of the CTIL/CTX application. The applicant is responsible for updating any information relevant to the product or the application.


In order to request an online screening, the applicant must contact the Head of Investigational Product Evaluation and Safety Section, Centre of Product and Cosmetic Evaluation. The screening officer will inform the applicant by email when the document was received. Within seven working days, the applicant will receive the results of the screening.


To know more about the Documents to be submitted, Administrative requirements, etc click this LINK.


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