With effect from 1 September 2021, applicants are required to submit the HSA’s acknowledgement email on the receipt of the Letter of Access from the DMF holder as documentary proof that all required documents from the DMF holder have been submitted to HSA. This applies for all registration applications that are supported by DMF. HSA has updated Appendix 11 of the Guidance for information on the documentary requirements in support of a DMF submission. This will facilitate timely screening of the applications once submitted in the e-system and avoid any unnecessary screening queries and stop-clock for clarifying the status and completeness of the DMF.
To enhance good submission practices by the industry, HSA has also provided further clarifications on the types of deficiencies that are considered major where the applications will not be accepted for screening. This will apply to applications submitted from 1 September 2021 onwards.
For applications submitted without the following documents, the applicant will be requested to withdraw the application as screening cannot proceed:
- Entire dossier sections (drug substance, drug product, clinical)
- Drug Master File (DMF) (if applicable)
- A copy of email acknowledgment from HSA on the receipt of the Letter of Access for applications supported by DMF (if applicable)
- Application checklist in MS WORD format (Appendix 2 or 3)
- Assessment reports (for verification route)
GUIDANCE ON THERAPEUTIC PRODUCT REGISTRATION IN SINGAPORE, AUGUST 2021
APPENDIX 11 GUIDELINE ON DRUG MASTER FILE (DMF), AUGUST 2021