(Updated 25 April 2024)
The guideline will be effective on 30 April 2024. However, the guideline will be accessible on NPRA website starting March 2024 to allow stakeholders to familiarize themselves with the contents of the guideline and make any necessary adjustments to their current processes or procedures.
No. Submission of CD-ROM for online screening is not allowed. Online file-sharing platforms that require the creation of new usernames and passwords for each individual officer will not be accepted. Applicants are encouraged to use the online file-sharing platforms such as Sharepoint, Box, Google Drive, Microsoft Onedrive, etc.
The trial site listed under the NPRA Phase I Unit Inspection & Accreditation Programme can conduct FIH studies in Malaysia. For more information on the programme, please refer to the link below.
It is specified in our guideline that "For local disposal, all investigational products should be disposed by the authorised bodies/ authority and documented." Hence, the drug destruction documentation should be provided.
According to CDCR 1984, Regulation 15 (6) it states that:-
Any person who wishes to import or manufacture any product solely for the purposes of treatment of any person suffering from a life threatening illness may on application be exempted by the Authority from the provisions of regulation 7 (1) subject to such conditions or restrictions as it may impose in such exemption.
Since the safety and efficacy of the investigational products are still in development, the access to the products as a treatment of a medical condition should be done in a clinical trial setting.
In general, the use of an investigational product after the trial has ended will be under compassionate use program. In Malaysia, the compassionate use programme is available to ensure continuous access of investigational products after a clinical trial has ended and before the investigational product is registered. Only subjects who had participated in the approved clinical trial involving CTIL and CTX are allowed in this programme on a named patient basis.
Please refer to this link below for more information.
Please contact below for further information:
Cawangan Pengurusan Formulari
Bahagian Amalan & Perkembangan Farmasi
03-7841 3378