Below are the key highlights of the new guideline:

1. Incorporation of Safety Reporting into CTIL/CTX guideline.

2. Discontinuation of CTIL/CTX sharing practice among different protocols

3. Updates on variation applications based on WHO GBT recommendations

a) Reintroduction of variation for change of investigator.

b) Removal of variation for additional quantities for the new protocol.

c) Addition of variation for change of name and address of the applicant’s company

4. FIH definition & process flow reengineering

5. Introduction of Appendix G2 Format for Manufacturing Drug Accountability Report

6. Introduction of new payment form - Borang Penyerahan Yuran Pemprosesan (NPRA/427/08) for processing fee payment.

Currently, FIH clinical trials involving New Chemical Entity, Herbal Products with Therapeutic Claims, locally manufactured COVID-19 vaccine and Biologic Products (except Cell and Gene Therapy Products) can 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-memperolehi-menggunakan-ubat-ubatan-memerlukan-kelulusan-khas-ketua.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.