Recently, HSA published an updated Appendix 3A – Guidance on Therapeutic Product Registration. This Application Checklist is intended to be used for the submission of a complete dataset in the ASEAN Common Technical Dossier (ACTD) format for NDA and GDA applications only.
Relevant Links:
- HSA’s questions and Answers document: https://go.gov.sg/qna-management-of-nitrosamine-impurities-in-therapeutic-products
- Guidance document for product registration: https://www.hsa.gov.sg/therapeutic-products/medicines-quality-and-compliance-monitoring/nitrosamine-impurities-in-medicines/guidance-for-product-registrants#:~:text=The%20HSA%20has%20developed%20a%20question-and-answer%20(Q&A),*%20Requirements%20for%20new%20and%20pending%20applications
- Assessment tool for Nitrosamine risk assessment: https://go.gov.sg/appendix-2-assessment-aid-for-assessing-nitrosamine-risk