Singapore legislation
Regulation 26
of Human Biomedical Research (Tissue Banking) Regulations 2019
Regulation 26
Quality and safety management systems
Subregulation 1
Every transplantational tissue bank must establish a system to ensure the quality and safety of any tissue under the supervision and control of the tissue bank, which is intended for use in research involving human tissue transplantation.
Subregulation 2
The transplantational tissue bank must ensure that the system mentioned in paragraph (1) must at the minimum take into consideration the following in relation to the tissue intended for use in research involving human tissue transplantation:
the qualifications of and training to be received by the personnel involved in the handling of tissue;
the method of processing and preservation to retain the biological function of tissue compatible with the intended use;
the appropriate labelling and conditions of storage of tissue;
the management of quality control and inventory;
the suitability and testing of donors of tissue.
Subregulation 3
Every transplantational tissue bank must establish an appropriate and effective system to ensure the recall of any tissue which had been unintentionally or otherwise erroneously supplied for use in research involving human tissue transplantation.
Subregulation 4
A transplantational tissue bank who or which contravenes paragraph (3) shall be guilty of an offence and shall be liable on conviction —
in the case of an individual, to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 2 years or to both; or (b)in any other case, to a fine not exceeding $20,000.