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Overview of Changes

The new version, GN-00:2026-1(E), introduces a significant update to the definition of "Medical Device" by incorporating a reference to an "Appendix 1" which lists additional items treated as medical devices under the MDACS. Additionally, there are revisions to how various definitions are presented and numbered, reflecting structural and organizational changes within the document. The references section has also been updated to reflect newer versions of GHTF and IMDRF documents.

Key Changes

• Addition of Appendix 1: A new appendix titled "Appendix 1 Items Specified for the Purpose of 2.38 (b)" has been added. This appendix lists "Injectable dermal fillers or mucous membrane fillers" as items treated as medical devices under MDACS.
• Revised Definition of Medical Device (2.38): The definition of "Medical device" in section 2.38 has been restructured. It now explicitly includes a sub-clause "(b) any items listed in Appendix 1". This integration of the appendix is a major change.
• Renumbering of Definitions: The numbering of definitions related to "Medical Device" has been updated. For instance, the original section 2.38 "Medical device" is now followed by a new section 2.39 "According to the characteristics and nature, medical device can be classified into at least the following different types:". This has caused a cascading effect of renumbering for subsequent definitions up to section 2.69.
• Revised References: Reference 5.2 has been updated from "Global Harmonization Task Force: Information Document Concerning the Definition of the Term “Medical Device”. Final Document SG1-N29R16:2005." to "Global Harmonization Task Force: Definition of the Terms ‘Medical Device’ . Final Document GHTF/SG1/N071:2012 .".

Suggestions for SOP Updates

• Update Definition of "Medical Device": The SOP must be updated to reflect the revised definition of "Medical Device" in Section 2.38, specifically including the new sub-clause referencing Appendix 1. This ensures that "Injectable dermal fillers or mucous membrane fillers" are recognized as medical devices under the MDACS.
• Incorporate Appendix 1 Content: The SOP should either directly incorporate the content of Appendix 1 or clearly reference it as an integral part of the definition of a medical device. This means the SOP needs to acknowledge that "Injectable dermal fillers or mucous membrane fillers" are now explicitly within the scope of MDACS.
• Verify Definition Numbering: Due to the renumbering of definitions, the SOP should be carefully reviewed to ensure all cross-references to definitions within the document are updated to reflect the new numbering scheme. For example, any mention of "Use error" (now 2.69) instead of its previous numbering needs to be corrected.
• Update References Section: The SOP's reference section should be updated to include the new version of Reference 5.2, which is now "Global Harmonization Task Force: Definition of the Terms ‘Medical Device’ . Final Document GHTF/SG1/N071:2012 .".

Overview of Changes

There are no substantive changes between the old and new versions of the "Guidance Notes on Registration of Pharmaceutical Products: New Drug Applications". The documents are identical.

Key Changes

N/A

Suggestions for SOP Updates

N/A

Overview of Changes

The new version of the Guidance Notes (GN-00:2026(E)) has undergone a revision with a specific change noted in the Revision History.

Key Changes

• Revision History Update: The Revision History section has been updated to include "Edition Number 5" with a "Date of Revision" of "4 May 2026". The "Summary of Revision" indicates that "Clause 2.38.7 is revised (formatting)". The corresponding "Reference Number" is "GN-00:2026 (E)".

Suggestions for SOP Updates

• Review and Update SOP Section on Definition of Medical Device: The Standard Operating Procedure (SOP) related to the definitions used in the Medical Device Administrative Control System (MDACS) should be reviewed to incorporate the formatting changes in Clause 2.38.7.
• Update Version Control: Ensure that the SOP's version control documentation reflects the update to GN-00:2026(E) as the current governing document for definitions.

Overview of Changes

The updated version of the "Guidance Notes on Classification of Products as 'Pharmaceutical Products' under the Pharmacy and Poisons Ordinance (Cap. 138)" maintains the core principles and structure of the previous version. The primary changes relate to the document's effective date and minor clarifications within the text.

Key Changes

• Document Date: The date of the guidance notes has been updated from "Feb 2024" to "Apr 2026".
• Clarification on Pharmaceutical Dose Form and Route of Administration: In section 5, a new paragraph 5.4 has been added. This paragraph explicitly states that "Pharmaceutical dose form and route of administration are important factors in determining whether product falls within the definition of a pharmaceutical product. Generally, products intended for human parenteral injection are classified as pharmaceutical products, unless they fall within the categories specified in Section 3.2 (e.g. proprietary Chinese medicines or medical devices) or otherwise considered on a case-by-case basis."
• Minor Wording Adjustments:
  • In section 2.1(a)(ii), the word "or" has been changed to "or".
  • In section 3.1.3, "product's" has been changed to "product's".
  • In section 3.2.1, "Ordinance" has been changed to "Ordinance".
  • In section 3.2.2, "on e" has been changed to "one".
  • In section 3.2.4, "combinati on" has been changed to "combination".
  • In section 5.1.3, "tablet, etc." has been changed to "tablet, injection etc.".
  • In section 5.4, the original text referenced "Appendix 5" which seems to be a typo, and has been corrected to "Section 3.2". The new version correctly refers to "Section 3.2".
  • In Appendix 2, "tyrosin e" has been changed to "tyrosine".
  • In Appendix 2, "lactobacillus (except genetically modified lactobacillus with a plasmid containing a gene sequence for a protein promoting the healing of skin wounds and an inducible promoter)" has been maintained.
  • In Appendix 2, "Vitamins (except injection form and other preparations under Appendix 5 )" has been changed to "Vitamins (except other preparations under Appendix 5 )".
  • In Appendix 5, Case 3, "cosmetic p roducts" has been changed to "cosmetic products".
  • In Appendix 5, Case 3, "leave-on ap plications" has been changed to "leave-on applications".
  • In Appendix 5, Case 3, "leave-on ap plications" has been changed to "leave-on applications".
  • In Appendix 5, Case 3, "leave-on ap plications" has been changed to "leave-on applications".
  • In Appendix 5, Case 3, "leave-on ap plications" has been changed to "leave-on applications".
  • In Appendix 5, Case 3, "leave-on app lications" has been changed to "leave-on applications".
  • In Appendix 5, Case 3, "leave-on ap plications" has been changed to "leave-on applications".
  • In Appendix 5, Case 3, "leave-on ap plications" has been changed to "leave-on applications".
  • In Appendix 5, Case 4, "1,3-Dimethylamylamine" has been maintained.
  • In Appendix 5, Case 5, "rinse -off" has been changed to "rinse-off".
  • In Appendix 5, Case 5, "leave -on" has been changed to "leave-on".
  • In Appendix 5, Case 6, "vitamin A w ith" has been changed to "vitamin A with".
  • In Appendix 5, Case 6, "vitamin B3 (nicotinic acid) with" has been changed to "vitamin B3 (nicotinic acid) with".
  • In Appendix 5, Case 6, "vitamin D with" has been changed to "vitamin D with".
  • In Appendix 5, Case 6, "vitamin K except vitamins K1 or K2 with" has been changed to "vitamin K except vitamins K1 or K2 with".
  • In Appendix 5, Case 7, "10mg or more" has been maintained.
  • In Appendix 5, Case 8, "ready -for-use" has been changed to "ready-for-use".
  • In Appendix 5, Case 8, "gallium citrate -Ga67" has been changed to "gallium citrate -Ga67".
  • In Appendix 5, Case 8, "sodium medronate / stannous fluoride" has been maintained.

Suggestions for SOP Updates

1. Update Document Reference: In your Standard Operating Procedure (SOP), update any references to the "Guidance Notes on Classification of Products as 'Pharmaceutical Products' under the Pharmacy and Poisons Ordinance (Cap. 138)" to reflect the new version dated "Apr 2026".
2. Incorporate New Paragraph 5.4: Add the new clarification regarding pharmaceutical dose form and route of administration to your SOP. Specifically, include the statement: "Pharmaceutical dose form and route of administration are important factors in determining whether product falls within the definition of a pharmaceutical product. Generally, products intended for human parenteral injection are classified as pharmaceutical products, unless they fall within the categories specified in Section 3.2 (e.g. proprietary Chinese medicines or medical devices) or otherwise considered on a case-by-case basis."
3. Review Appendix 2 - Vitamins: Note the change in Appendix 2 regarding vitamins. The old version excluded "injection form and other preparations under Appendix 5" from being considered medicinal. The new version excludes "other preparations under Appendix 5". While the difference is subtle, ensure your SOP reflects the most current exclusion criteria. If your SOP details specific vitamin classifications, review and update these based on this clarification.
4. Check Cross-References: Verify that all internal cross-references within your SOP that refer to sections or appendices of the Guidance Notes are still accurate after the update. Pay particular attention to any references to Section 3.2 and Appendix 5.

Overview of Changes

The new version of the "Guidance Notes on Registration of Pharmaceutical Products: Specific Requirements for New Drug Applications of Advanced Therapy Products via Abridged Evaluation or Verification Routes" (Version 4.0, effective 31 March 2026) introduces a consequential update due to the introduction of new application categorization and evaluation routes. It also includes cross-referencing to the new set of "<Guidance Notes on Registration of Pharmaceutical Products: New Drug Applications>".

The "Guidance on Application of Certificate of Drug/Product Registration — Advanced Therapy Products" (Version 3.1) will remain applicable to applications accepted for evaluation prior to 31 March 2026 and will remain in effect for one year until 30 March 2027.

Key Changes

• Introduction of New Application Categorization and Evaluation Routes: The primary driver for the update to Version 4.0 is the establishment of new ways to categorize and evaluate applications for Advanced Therapy Products (ATPs). This implies a shift in how applications will be processed and assessed.
• Cross-referencing to New "Guidance Notes on Registration of Pharmaceutical Products: New Drug Applications": Version 4.0 explicitly states that it cross-references to a new set of guidance notes titled "<Guidance Notes on Registration of Pharmaceutical Products: New Drug Applications>". This suggests that applicants will need to consult these new notes in conjunction with the ATP-specific guidance.
• Transitional Provision for Older Guidance: The "Guidance on Application of Certificate of Drug/Product Registration — Advanced Therapy Products" (Version 3.1) is being phased out. It will continue to be valid for applications accepted before the effective date of Version 4.0 (31 March 2026) and for a subsequent transitional period of one year.

Suggestions for SOP Updates

• Update SOP Section on ATP Application Process: Review and revise the SOP section that details the process for applying for ATP registration. Ensure it reflects the new application categorization and evaluation routes introduced with Version 4.0.
• Incorporate Cross-References: Update the SOP to include explicit cross-references to the new "<Guidance Notes on Registration of Pharmaceutical Products: New Drug Applications>" as required by Version 4.0.
• Clarify Transitional Period: The SOP should clearly outline the transitional arrangements for Version 3.1 of the "Guidance on Application of Certificate of Drug/Product Registration — Advanced Therapy Products," specifying its continued applicability for a limited period after the effective date of Version 4.0.
• Training on New Routes: Develop and implement training for relevant personnel on the new application categorization and evaluation routes. This should cover how to identify which route applies and the specific requirements for each.
• Document Control Update: Ensure that version control for the SOP accurately reflects the adoption of Version 4.0 of the guidance notes and the eventual retirement of Version 3.1.

Overview of Changes

The new version of the "Guidance Notes on Registration of Pharmaceutical Products: Specific Requirements for New Drug Applications of Advanced Therapy Products via Abridged Evaluation or Verification Routes" (Version 4.0, effective 31 March 2026) introduces a consequential update upon introducing new application categorization and evaluation routes, and cross-references to a new set of "Guidance Notes on Registration of Pharmaceutical Products: New Drug Applications."

The "Guidance on Application of Certificate of Drug/Product Registration — Advanced Therapy Products" (Version 3.1) will remain applicable to applications accepted for evaluation prior to 31 March 2026 and will remain applicable for one year until 30 March 2027.

Key Changes

There are no substantive changes in the content of the "Guidance Notes on Registration of Pharmaceutical Products: Specific Requirements for New Drug Applications of Advanced Therapy Products via Abridged Evaluation or Verification Routes" between the old and new versions being compared. The primary change is the update to Version 4.0 and the cross-referencing to new application categorization and evaluation routes. The "Guidance on Application of Certificate of Drug/Product Registration — Advanced Therapy Products" is also noted to have a transitional period of applicability.

Suggestions for SOP Updates

• Update SOP references: Review all internal SOPs that reference the "Guidance Notes on Registration of Pharmaceutical Products: Specific Requirements for New Drug Applications of Advanced Therapy Products via Abridged Evaluation or Verification Routes." Update any version-specific references to reflect Version 4.0.
• Incorporate new guidelines: Ensure that any SOPs referencing the "Guidance Notes on Registration of Pharmaceutical Products: New Drug Applications" are updated to reflect the new set of guidelines as indicated in the change history of Version 4.0.
• Address transitional period: If any SOPs are specific to the application process under Version 3.1 of the "Guidance on Application of Certificate of Drug/Product Registration — Advanced Therapy Products," ensure they are updated or that a clear process is defined for handling applications submitted before the transition date of 31 March 2026 and the extended applicability date of 30 March 2027.