Singapore legislation
Regulation 18
of Health Products (Clinical Research Materials) Regulations 2016
Regulation 18
Production of and time for keeping of records
Subregulation 1
A person who is required to keep any record under this Division must —
keep the records for the applicable period specified in paragraph (2) or (3); and
produce the records for inspection when required by the Authority at any reasonable time during the applicable period.
Subregulation 2
For records relating to any manufacture, assembly and testing of clinical research material, the applicable period is as follows:
in the case of registered and unregistered investigational clinical research material and unregistered auxiliary clinical research material — 5 years after the completion or discontinuation of the last clinical trial in which the batch of that material was used;
in the case of registered auxiliary clinical research material, the longer of the following periods:
one year after the expiry date of the material;
5 years after the date of such manufacture, assembly and testing;
in the case of traceability records relating to clinical research material that is a CTGT product — 30 years after the expiry date of the product or any other shorter period that the Authority allows in a particular case.
Subregulation 3
For records relating to the receipt and supply of, or the putting to some other use, disposal or export, of clinical research material, the applicable period is as follows:
where the clinical research is not a regulated trial and —
the clinical research material is not a CTGT product — 2 years after the supply, putting to some other use, disposal or export, as the case may be; or
the clinical research material is a CTGT product and —
the records do not relate to traceability — 2 years after the supply, putting to some other use, disposal or export, as the case may be; or
the records relate to traceability — 30 years after the expiry of the CTGT product, or any other shorter period that the Authority allows in a particular case;
where the clinical research is a regulated clinical trial, the period for which records of the trial must be kept under regulation 23(2)(c) of the Health Products (Clinical Trials) Regulations 2016 (G.N. No. S 331/2016) or regulation 23(2)(c) of the Medicines (Clinical Trials) Regulations 2016 (G.N. No. S 335/2016), as the case may be.