Singapore Health Sciences Authority Updates the Guidance for Product Defect Reporting and Recall Procedures for Therapeutic Products and Cells, Tissue and Gene Therapy Products

Singapore Health Sciences Authority has updated the Guidance for Industry: Product Defect Reporting and Recall Procedures for Therapeutic Products  and Cells, Tissue and Gene Therapy Products (CTGTPs). The main updates include:

1.      Extending the scope of the guidance to include CTGTPs as the regulations of CTGTPs have been effected on 1 March 2021.

2.      Extending the scope of the guideline to include TPs and CTGTPs that are manufactured in Singapore for distribution outside of Singapore, used in clinical trials in Singapore and authorised via the pandemic special access route.

3.      Emphasising that appropriately trained and experienced personnel should be responsible for managing complaint and quality defect investigations and for deciding the measures to be taken to mitigate any potential risk(s) including recalls. Sufficient personnel and resources should be made available for the handling, reviewing and investigation of complaints and quality defects and for implementing any risk mitigation measures, as well as for the management of interactions with HSA.

4.      Describing the minimum information required for the submission of an initial product defect report and the information that is required in the investigation report.

5.      Specifying the timelines for submission of investigation reports

6.      Reiterating that submission of Minor Variation (MIV) applications should not be used as a mechanism for reporting product defects to HSA. Where the submission of a MIV application is required as part of the corrective and preventive actions, the product defect reporting form should first be submitted to HSA before submission of the MIV application.

7.      Providing pointers on the content of Dear Purchaser Letters and Dear Healthcare Professional Letters.

8.      Included the need for companies to verify that the recall communications had been received by the customers and that they understood and followed through the recall instructions. If the effectiveness checks indicate that the recall communications were not received and/or the instructions were not followed, companies should take steps to rectify the issues.

9.      Illustrating examples of non-reportable defects

10.  Specifying the conditions for the supply of out of specification batch of CTGTP

The online product defect reporting form and product recall completion form have also been updated accordingly.
Please refer to the link for more information:-
Link to guidance:

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