監管動態

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.

Overview of Changes

The new version of the "General Requirements for Master Formula and Specifications for Non-Biological Products" introduces several clarifications and additions, particularly concerning the information required in the Master Formula and the guidelines for Specifications. Key changes include the explicit inclusion of references on quality standards in the Master Formula and a more detailed breakdown of general tests for product specifications, including a new Annex A with a comprehensive table.

Key Changes

• Master Formula - References on Quality Standards: The new version explicitly requires the inclusion of "references on quality standard(s) of the active ingredient(s) and excipient(s) (e.g. pharmacopoeial monographs or if no relevant pharmacopoeial monographs, manufacturer’s in-house specifications)" as part of the master formula. The old version mentioned that the certificate holder "may include the appropriate references".
• Master Formula - Overage of Active Ingredient: Question 3 in the Q&A section regarding overage of active ingredient remains largely the same but is renumbered.
• Master Formula - Change of Quality Standard: Question 5 in the old version regarding changes to quality standards has been significantly expanded in the new version (renumbered as Question 5). It now clarifies that approval is not required for changes from "in-house standard to pharmacopoeia standard, from one pharmacopoeia standard to another," but CORP application is still required when the quality standard is stated in the master formula.
• Master Formula - Change in Physical Form: Question 6 in the new version addresses changes in the "physical form of active ingredient (e.g. change to micronized form)" and specifies that supporting documents like "certificate of analysis of active substance, updated master formula and specifications (if applicable) together with stability reports" should be submitted.
• Master Formula - Change in Salt/Ester/Derivative: A new question (Question 7) has been added to the Master Formula Q&A concerning changes in the "salt/ester complex/derivative/isomer of active substance," stating that an "Application for new product registration is required."
• Specifications - Acceptance Criteria Reference: In section (c) of the Specifications, the new version requires "acceptance criteria with reference to a specified pharmacopoeia or ICH/WHO guidelines (See Annex A )". The old version stated "acceptance criteria".
• Specifications - General Tests: The Q&A on general tests in Specifications has been significantly expanded. It now provides a detailed list of pharmacopoeias and ICH/WHO guidelines that tests and acceptance criteria should be based on (e.g., "Pharmacopoeia of the People’s Republic of China", "British Pharmacopoeia", etc.).
• Specifications - Annex A: A new Annex A has been introduced, providing a comprehensive table detailing "general tests for reference" across different dosage forms (Oral, Cutaneous, Ear/Nasal, Eye, Parenteral, Solid, Liquid, Semi-Solid).

Suggestions for SOP Updates

• Master Formula - Section 2.1 (Content of Master Formula):
  • Update Requirement (e): Add a new sub-point to explicitly state that "References on quality standard(s) of active ingredients and excipients (e.g., pharmacopoeial monographs or manufacturer’s in-house specifications) must be included."
  • Update Q&A 5 (Change in Quality Standard): Revise the SOP section referencing this Q&A to reflect the clarification that changes from in-house to pharmacopoeial standards, or between pharmacopoeial standards, do not require CORP application, but must still be justified and comply with change control GMP.
  • Add New Q&A 6 (Change in Physical Form): Incorporate guidance on the supporting documentation required for changes in the physical form of an active ingredient.
  • Add New Q&A 7 (Change in Salt/Ester/Derivative): Add a statement that changes in the salt, ester, complex, derivative, or isomer of an active substance require a new product registration application.
• Specifications - Section 3.1 (Content of Specifications):
  • Update Requirement (c): Modify the wording to state that specifications must include "the relevant tests for final release of the drug product and their acceptance criteria with reference to a specified pharmacopoeia or ICH/WHO guidelines (See Annex A)."
• Specifications - Section 3.2 (Q&A - General Tests):
  • Revise Content: Update the SOP to detail the specific pharmacopoeias (e.g., PRC, BP, EP, IP, JP, USP) and ICH/WHO guidelines that should be referenced for general tests and acceptance criteria.
  • Incorporate Annex A: Integrate the information from the new Annex A into the SOP, possibly as an appendix, to provide a clear reference table for general tests based on dosage form.
• General Update: Ensure all references to "CORP application" are consistent with the updated definitions and requirements in the new version.
• Change Control: Reiterate the importance of adhering to "change control" GMP requirements when implementing changes to methods of analysis or specifications, as mentioned in the Q&A sections.