Singapore legislation
Regulation 23A
Regulation 23A
Traceability of applicable CTGT products used in clinical trials
Subregulation 1
The sponsor of a clinical trial that involves any applicable CTGT product must ensure that a system of traceability that complies with paragraph (2) is established and maintained.
Subregulation 2
The system mentioned in paragraph (1) must at the minimum enable the traceability of the CTGT product and its starting and raw materials, including all substances that may come into contact with the cells or tissue it contains during any of the following processes:
sourcing;
procurement;
processing;
testing;
packaging;
storage;
transport;
delivery to the trial site where the CTGT product is used or administered;
any other final reconciliation, disposal or destruction of the CTGT product.
Subregulation 3
The principal investigator of a clinical trial that involves any applicable CTGT product must ensure that a system of traceability is established and maintained at the trial site such that the CTGT product may be linked to the subject who received it, and vice versa.
Subregulation 4
The sponsor and principal investigator mentioned in paragraphs (1) and (3) must keep all data obtained from the system of traceability for at least 30 years after the expiry date of the CTGT product or any other shorter period that the Authority allows in a particular case.