FAQ on Clinical Trials in Malaysia (2)

Below are the main amendments/changes in the new guideline:

1) Reporting SUSAR

  • Local SUSAR (Malaysia trial sites): Individual SUSAR report in the format of CIOMS must be notified to NPRA.

  • SUSAR outside of Malaysia trial site: Only Six-monthly SUSAR line listing report must be notified to NPRA. Individual SUSAR reports is not       required

2) Notification of Serious AEFI and AESI occurred in vaccine trials to NPRA

3) Notification of Annual Development Safety Update Report (DSUR) to NPRA.

4) Updated Appendix H2: Reporting Requirements and Timeline and Updated Appendix H3: Process of Qualifying SUSAR Reporting

     For more information on the safety reporting updates, please refer to FAQS on Safety Reporting in Clinical Trials (Updated 30 April 2025)

5) Timeline for variation applications

In line with government’s environment-friendly initiative to reduce paper usage, please be informed that effective 1 July 2025, following a satisfactory online screening, new CTIL/CTX applications can be submitted in CD-ROM format. However, the following documents must still be submitted in hardcopy:

A) Cover letter

B) Complete and signed CTIL/CTX application form

C) Declaration by Principal Investigator

D) Declaration by Sponsor (for FIH study only)

E) Borang Penyerahan Yuran Pemprosesan processed by the Finance Section

F) Official receipt for CTIL processing fee

Due to the writable and reusable nature of the USB drive which increases the risk of tampering, accidental modification, and malware or virus transmission, CD-ROM remains the preferred medium for the softcopy documents submission.

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. 

Starting from 1st April 2025, CTIL/CTX application of First-in-Human (FIH) clinical trials involving all categories of products can now be accepted for review. 

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.

https://www.npra.gov.my/index.php/en/component/sppagebuilder/910-list-of-accredited-phase-i-units.html

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.

https://pharmacy.moh.gov.my/ms/dokumen/garis-panduan-permohonan-ubat-kelulusan-khas-ukk-fasiliti-fasiliti-kkm.html

Please contact below for further information:

Cawangan Pengurusan Formulari

Bahagian Amalan & Perkembangan Farmasi

03-7841 3378

Please see the directive issued by Director General of Health of Malaysia here:

Surat Pekeliling Ketua Pengarah Kesihatan Malaysia Bil. 4/2015 - Tatacara Prosedur Permohonan Berkaitan Penyelidikan Sel Stem Dan Cell-Based Therapies (Tahun 2015)

In addition, if the Cell and Gene Therapy products requires CTIL and/or CTX application, please refer to Malaysian Guideline for Application of CTIL/CTX 8th Edition.

For Registration Guidance involving Cell and Gene Therapy Products, please refer to the directive here:

Direktif untuk menguatkuasakan penggunaan Guidance Document and Guidelines for Registration of Cell and Gene Therapy Products (CGTPs), December 2015 dan Good Tissue Practice Guideline, 2nd edition, December 2015.

Please refer to https://clinicalresearch.my/wp-content/uploads/2023/07/REVISED-DCT-Guidance-Document-Cover-Back-page-2.pdf for more information.

In accordance with NPRA Directive No. 9 of 2026 dated 19 February 2026, where an official GMP Certificate cannot be obtained because the local authority does not provide such certification for dedicated IP manufacturers or final batch releasers (e.g., in the US or China), the applicant may submit the Lampiran A: Declaration on Good Manufacturing Practice (GMP) Compliance for Investigational Medicinal Product (IMP) Manufacturer by a Competent Person as attached in the directive as supporting document for GMP compliance evidence. However, the compliance claims declared in the document may be subject to further verification by NPRA.

Please refer to the link below for the directive:
https://npra.gov.my/index.php/en/directive-general/1527824-direktif-untuk-deklarasi-personel-kompeten-amalan-perkilangan-baik-apb-bagi-produk-perubatan-penyelidikan-bilangan-9-tahun-2026.html

According to the NPRA Directive No. 7 of 2026 dated 29 January 2026, the Malaysian Guideline for Good Clinical Practice (GCP), 5th Edition, officially comes into effect on 1^st February 2026. However, to ensure a seamless transition, a grace period has been granted until 31^st December 2026. Full compliance with the 5th Edition is mandatory for all clinical trial activities effective 1^st January 2027.

Please refer to the link below for the directive:

https://npra.gov.my/index.php/en/directive-general/1527819-direktif-untuk-penggunaan-malaysian-guideline-for-good-clinical-practice-gcp-5th-edition.html

According to ICH E6(R3) Good Clinical Practice (GCP) Guideline, a Sponsor refers to an individual or organization that has the overall responsibility for initiating, coordinating, managing, and financing a clinical trial.

For all IIT conducted at MOH facilities, the Principal Investigator (PI) is responsible for holding the roles of both Sponsor and Sponsor-Investigator. By initiating and conducting the study, the PI assumes full accountability for the following:

• Study Design: Developing the framework and methodology of the research.
• Monitoring and Reporting: Overseeing trial progress and fulfilling safety reporting requirements.
• Regulatory Compliance: Ensuring the study adheres to all effective legal, ethical, and GCP requirements.
• Data Integrity: Managing the quality and integrity of study data throughout the trial process.