In March 2020, HSA had communicated the regulatory requirement to conduct risk assessments for all therapeutic products containing chemically synthesized drug substances to identify any potential risk of nitrosamine impurities.
Where the potential risk is identified, confirmatory testing should be done, and the necessary changes should be made to mitigate the risk.
Implementation was conducted in a 3 steps process, with more details in the following link:
https://www.hsa.gov.sg/therapeutic-products/medicines-quality-and-compliance-monitoring/nitrosamine-impurities-in-medicines/guidance-for-product-registrants
In December 2023, HSA had published a list of HSA’s Acceptable Intake for Certain Known Nitrosamines.
The list can be found at the following link: https://www.hsa.gov.sg/docs/default-source/hprg-vcb/product-defect-and-recall/appendix-1_hsa-recommended-acceptable-intake-for-certain-known-nitrosamines.pdf
HSA will continue to update this list as more information becomes available.