No. | Change | Description | The following guidance documents have been revised: |
1. | Enhancement of application checklists for NDA, GDA and MAV submission | The application checklists for NDA, GDA and MAV submissions (Appendix 2A, 2B, 3A, and 3B) have been revised to improve usability for applicants, serving as submission aids to ensure completeness of application dossiers and reduce screening queries. The new checklists in MS Excel format are now available for use in application submissions.
The MS Word format will continue to be accepted during the transition period until 31 October 2025. Applicants are strongly encouraged to familiarise themselves with the new format, which will fully replace the MS Word format from 1 November 2025.
| The revised application checklists are now in Excel format: - Appendix 2A_Application checklist_ICH CTD_NDA_GDA
- Appendix 2B_Application checklist_ICH CTD_MAV
- Appendix 3A_Application checklist_ACTD_NDA_GDA
- Appendix 3B_Application checklist_ACTD_MAV
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| 2 | Clarification on prerequisite documents for acceptance of application for screening | Applications will not be accepted for screening if any of the prerequisite documents is omitted:
- Module 3/Part 2 Drug Substance dossier
- Module 3/Part 2 Drug Product dossier
- Module 4/Part 3 Non-Clinical dossier (if applicable)
- Module 5/Part 4 Clinical dossier
- Drug Master File (DMF) and its accompanying Letter of Access (if applicable)
- Assessment report from Reference Agencies (for verification route)
- Duly completed Application Checklist in MS EXCEL format
- Duly completed Patent Declaration Form
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| 3 | Updated acceptable proof of GMP compliance for drug product manufacturing sites |
The acceptable proof of GMP compliance issued by a competent authority may be in the form of:
- Valid PIC/S GMP Certificate (Certificate of GMP Compliance), or
- Establishment Inspection Report (EIR) and close out letter issued by US/FDA.
Please note that proof of compliance must be valid at the time of submission and not less than 6 months before expiry. The above applies to NDA, GDA and MIV-1/2 applications.
| - Main guide, Section 15 and 18
- Appendices 13A, 13B, 14A and 14B
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| 4 | Introduction of a new online form for DMF submission | The DMF submission process has been streamlined and DMF holders can now notify HSA and obtain a DMF reference number for submission of the dossier using a new online form. Applicants are no longer required to submit a separate DMF receipt acknowledgement issued by HSA in their product registration application. | - Main guide, Sections 15.3.1 and 18.3.1
- Appendix 11
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| 5 | Streamlining of dossier requirements for MAV-1 verification evaluation route | Complete assessment reports obtained from the public domain for the primary reference agency are now acceptable to support MAV-1 applications via verification evaluation route.
| - Main guide, Section 24.2.5.3
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| 6 | Enhancement of criteria for forensic classification of TPs (POM/P/GSL) | The regulatory considerations for POM, P and GSL, have been enhanced to facilitate and provide clarity on the criteria for reclassification.
| - Main guide, Sections 1.2, 25
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| | Other revisions | The relevant sections of the Guidance documents listed below have been updated with minor amendments and editorial changes for better clarity:
- Definition of abridged evaluation route for Biosimilar applications
- RMP requirements for GDAs
- Requirements for documents in PDF format
- PRISM submission requirements
- Conditions for MIV-1 checklists B16 (Appendix 13A) and B6 (Appendix 14A)
| - Main guide
- Appendix 5, 7, 17, 13A and 14A
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