18 Feb 2021
ADDENDUM TO MOH DIRECTIVE NO. 6/2020 ON THE USE OF CELL, TISSUE AND GENE THERAPY PRODUCTS MANUFACTURED IN-HOUSE BY HEALTHCARE INSTITUTIONS
We refer to Directive No. 6/2020 on the Use of Cell, Tissue and Gene Therapy Products Manufactured In-house by Healthcare Institutions (“the Directive”) which was issued on 13 November 2020 and came into effect on 1 February 2021. This circular seeks to inform all licensees of hospitals, medical and dental clinics that there is a change in the applicable Regulations which govern Class 2 cell, tissue and gene therapy products (CTGTPs) manufactured in-house for use in research.
2. In view that the Health Products Act (Amendment of First Schedule) Order 2021 has come into effect on 1 March 2021, the Medicines (Clinical Trials) Regulations no longer apply to in-house manufactured Class 2 CTGTPs used in research. As CTGTPs are now specified and defined as a distinct category of products under the Health Products Act, all Class 2 CTGTPs used in research will be subject to the Health Products (Clinical Trials) Regulations instead. Please find appended a revised Annex A of the Directive, with the aforementioned change indicated in red.
3. In line with the date from which the controls for CTGTPs are effectively brought under the Health Products Act, these changes to the Directive will take effect from 1 March 2021.
4. For any queries or further clarifications, please email eLis@moh.gov.sg. Thank you
A/PROF KENNETH MAK
DIRECTOR OF MEDICAL SERVICES
MINISTRY OF HEALTH
The full document can be downloaded below:
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