• December 21, 2015 at 9:23 am

    Definition
    An approval by Drug Control Authority (DCA) authorising the applicant to manufacture any local unregistered product for the purpose of clinical trial.

    Product that require CTX
    An unregistered product including placebo manufactured locally for the purpose of the clinical trial.

    Prior to manufacturing product locally, the sponsor is required to apply for CTX from the Drug Control Authority (DCA).

    Who can apply for CTX

    1. Any investigator
    2. An authorised person from a locally registered
    pharmaceutical company/sponsor/Contract
    Research Organisation (CRO) with a permanent
    address in Malaysia
    Note:
    a) Application for CTX containing a ‘poison/drug’ should be
    made by a Licence A holder
    b) The holder of a CTX for a particular product need not
    necessarily conduct the clinical trial himself or herself.

    Responsibility of the applicant

    The applicant shall be responsible for the product and all information supplied in support of his/her CTX application for his/her product. He/she shall be responsible for updating any information relevant to the product or application.

    Any person who knowingly supplied any false or misleading information in connection with his/her application for CTX commits an offence under the Control of Drug and Cosmetics Regulations 1984.

    The license holder shall ensure that adequate precautions are taken for all study medication such as storage in securely locked cabinet, access to which is limited to prevent theft or illegal distribution.

    Outline of CTX application procedures

     

    Documents timeline

    BE study protocol
    Subject information sheet
    Inform consent
    NMRR Registration ID
    Independent Ethics committee approval letter

    * PD to inform CA regarding Annex B document for CTX application of new drugs at least 2 months in advance

    Submission of CTX application to NPCB until obtained CTX approval = 1-2 month

    Documents required in a application for CTX

    A complete application form with NMRR Registration ID signed by the applicant

    Two copies of Application Submission Form

    Two copies of Submission Checklist

    Company Registration Certificate

    A copy of License A of the applicant

    Good Clinical Practice (GCP) certificate for investigator of each trial site.

    Approval letter by Ethics Committee of the Institution(s) where the clinical trial is to be conducted.

    Certificate of Good Manufacturing Practices (GMP) or a GMP Compliance Statement from manufacturer and repacker.

    Study Protocol and Amendments (Annex A) signed by PI

    Informed Consent Form (Initial version only)

    Pharmaceutical Data (Annex B)

    Investigator’s Brochure (Annex C)

    Published Clinical Data (if available)

    Annex B: Format for Pharmaceutical Data on Dosage Form

    1.Finish Product
    2.Manufacturing of product
    3.Quality control
    4.Stability of product
    5. Finished product CoA
    6. Containers and packing
    7. Labelling