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

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.

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 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.