Regulatory News

Overview of Changes

The new version of the "Guidance Notes on the Application for Certificate for Clinical Trial/Medicinal Test" (Version January 2026) primarily introduces minor wording changes and updates to specific sections concerning the "stop-clock" mechanism and the submission of NMPA approval documents. The core content and regulatory requirements remain consistent.

Key Changes

• Section 5.1.13 - NMPA Approval Document: The phrase "Drug clinical trial approval document ( 藥物臨牀試驗通知書 )" has been updated to "Drug clinical trial approval document ( 藥物臨牀試驗批准通知書 )".
• Section 5.1.14 - NMPA Protocol Submission: The original document stated "A copy of the proposed protocol submitted to NMPA." The new version specifies "A copy of the proposed protocol approved by NMPA." Additionally, a remark has been added: "(Remarks: For studies which are under evaluation by the NMPA and approval is not yet available, an amendment application could be submitted at a later stage upon NMPA’s approval.)"
• Section 6.3 - Stop-Clock End Condition (Committee Consideration): The wording has been clarified. Previously, for applications requiring Committee consideration, the stop-clock ended upon "issuance of approval in principle letter." The new version states it ends "when the application is presented for consideration by the Committee for the first time."
• Section 6.4 - Applicant's Stop-Clock and Committee Consideration:
  • The phrase "within 60 working days for normal applications" in reference to the applicant's response time has been changed to "within 45 working days for general applications".
  • The phrase "within 60 working days for applications that require Committee consideration" has been clarified to "For applications that require consideration by the Committee, the total response time before the application is ready for presentation to the Committee for consideration should be within 60 working days."
  • A new sentence has been added: "For the application which the Committee considered additional information is required, the applicant must submit an initial response to the Committee's request within 30 working days; otherwise, the application would be brought forward to the Committee for consideration of refusal."
• Section 6.6 - Stop-Clock Illustration Reference: The reference to Appendix 2 has been updated from "illustration of the stop -clock mechanism for normal applications" to "illustration of the stop -clock mechanism for general applications".

Suggestions for SOP Updates

• Review Section X.X related to NMPA Submissions: Update the SOP to reflect the change in the required document from a "notice" (通知書) to an "approval" (批准書) for NMPA drug clinical trial approval. Also, incorporate the new remark regarding amendment applications for pending NMPA approvals.
• Update Section Y.Y on Stop-Clock Mechanism:
  • Clarify the precise end-point of the stop-clock for applications requiring Committee consideration, as per the revised Section 6.3.
  • Amend the applicant's response time for "general applications" to 45 working days, as per the revised Section 6.4.
  • Ensure the SOP accurately reflects the total response time requirement of 60 working days for applications requiring Committee consideration before presentation.
  • Add the new requirement for a 30-working-day initial response to requests for additional information from the Committee, as detailed in the revised Section 6.4.

Overview of Changes

The updated version of the Guidance Notes on Registration of Medical Gases (Version Jan 2026) includes a new section, "Compliance with the Prevention of Bribery Ordinance," which was not present in the previous version (Version June 2024). This new section outlines prohibitions against offering advantages to government officers or members of statutory organizations.

Key Changes

• New Section Added: A new section titled "Compliance with the Prevention of Bribery Ordinance" has been added on Page 7 of the new version.
• Content of New Section: This section states that "Applicants and their employees or agents must not offer an advantage as defined in the Prevention of Bribery Ordinance (Cap. 201) to any government officer or Members of statutory organisations (including but not limited to the Pharmacy and Poisons Board and its Committees) in connection with their applications or while having dealings of any kind with government departments or statutory organisations."

Suggestions for SOP Updates

• Introduce a new SOP section or update an existing one to incorporate the requirements related to the Prevention of Bribery Ordinance.
• Specifically mention the prohibition of offering advantages to government officers or members of statutory organizations in the context of applications and dealings with regulatory bodies.
• Clarify that this applies to applicants, their employees, and agents.
• Reference the Prevention of Bribery Ordinance (Cap. 201) as the governing legislation.

Overview of Changes

The new version of the "Guidance Notes on Registration of Biosimilar Products" (Jan 2026) introduces a new section, "Compliance with the Prevention of Bribery Ordinance," which was not present in the previous version (Aug 2021). This section outlines the prohibition of offering advantages to government officers or members of statutory organizations in connection with applications or dealings with these entities. All other sections and content appear to be identical between the two versions.

Key Changes

• New Section: "Compliance with the Prevention of Bribery Ordinance" has been added as a new section, appearing on Page 11 of the Jan 2026 version.
  • This section states: "Applicants and their employees or agents must not offer an advantage as defined in the Prevention of Bribery Ordinance (Cap. 201) to any government officer or Members of statutory organisations (including but not limited to the Pharmacy and Poisons Board and its Committees) in connection with their applications or while having dealings of an y kind with government departments or statutory organisations."

Suggestions for SOP Updates

• Add New Section: Incorporate the content of the new "Compliance with the Prevention of Bribery Ordinance" section into the SOP.
• Review Compliance Procedures: Review existing SOPs related to interactions with regulatory bodies and government officials to ensure they align with the principles outlined in the new "Compliance with the Prevention of Bribery Ordinance" section. This may involve:
  • Adding specific clauses or statements within the SOPs that reinforce the prohibition of bribery.
  • Potentially including training requirements for personnel who interact with regulatory authorities to ensure awareness of these requirements.
  • Ensuring that any gift or entertainment policies within the company explicitly comply with the Prevention of Bribery Ordinance as referenced in the guidance.

Overview of Changes

The revision history indicates a new version of the guidance notes, GN-09:2025(E), has been released, superseding GN-09:2024-2(E). The specific changes noted in the revision history are the addition of "Clause 6.2 (Renewal of listing)" and the revision of "Clause 6.1.1".

Key Changes

• Clause 6.1.1 Revised: The original Clause 6.1.1 stated: "If an application for inclusion on the List of Distributors is approved, the applicant will be included on the List for three (3) years. The listed Distributor should apply for renewal of its current inclusion on the List of Distributor (current listing) not less than three (3) months before its expiry through the submission of a renewal application form and requisite documents as specified by the MDD. If the current listing expires prior to a decision of its application for renewal is made by the MDD, its current listing shall remain in effect until there is a decision." The new version of Clause 6.1.1 in GN-09:2025(E) now reads: "If an application for inclusion on the List of Distributors is approved, the applicant will be included on the List for three (3) years."

• Clause 6.2 (Renewal of listing) Added: This is a new clause introduced in the latest version. The original document had a "Clause 6.2 Fees", which is now moved and renumbered as "Clause 6.3 Fees". The new "Clause 6.2 Renewal of listing" outlines the specific timeframe for submitting renewal applications.

  • New Clause 6.2.1: "The listed distributor shall submit an application for renewal of the listing to the MDD between 12 weeks and 1 year (inclusive) before the expiry of the three -year validity period. No renewal application will be accepted outside of this submission window."
  • New Clause 6.2.2: "Applicants shall submit a new application if the distributor listing has expired."

Suggestions for SOP Updates

1. Update SOP for Clause 6.1.1 Revision:

   • Locate the section in your SOP that addresses the validity period of distributor listing.
   • Revise the SOP to state that the listing is for three (3) years, and remove any specific guidance on the renewal application timeframe that was previously derived from the old Clause 6.1.1. The new SOP should reflect the simplified statement of initial approval duration.

2. Update SOP for New Clause 6.2 (Renewal of listing):

   • Create a new section in the SOP or update an existing section dedicated to "Renewal of Distributor Listing."
   • Incorporate the specific submission window for renewal applications: "between 12 weeks and 1 year (inclusive) before the expiry of the three-year validity period."
   • Explicitly state that applications submitted outside this window will not be accepted.
   • Include the requirement for a new application if the distributor listing has expired.

3. Review and Renumber Sections:

   • Ensure that any references within your SOP to sections under "6. Administrative Provisions" are updated to reflect the renumbering caused by the introduction of the new "Clause 6.2 Renewal of listing" and the relocation of "Fees". Specifically, the original "Clause 6.2 Fees" is now "Clause 6.3 Fees", "Clause 6.3 Undertaking by Applicant" is now "Clause 6.4 Undertaking by Applicant", "Clause 6.4 Delisting of Distributors" is now "Clause 6.5 Delisting of Distributors", "Clause 6.5 The List of Distributors" is now "Clause 6.6 The List of Distributors", and "Clause 6.6 Appeal" is now "Clause 6.7 Appeal". The table of contents and all internal cross-references within the SOP should be adjusted accordingly.

Overview of Changes

The latest version of GN-07 introduces a new clause related to the renewal of importer listings and revises an existing clause concerning the renewal process.

Key Changes

• Clause 8.2.1 (Renewal of listing) is revised. The previous version stated: "The listed importer may apply for renewal of the current inclusion on the List of Importers (current listing) not less than 12 weeks before the expiry date through the submission of a renewal application form and requisite do cuments as specified by the MDD. If the current listing expires prior to a decision of its application for renewal is made by the MDD , its current listing shall remain in effect until there is a decision." The new version states: "The listed importer shall submit an application for renewal of the listing to the MDD between 12 weeks and 1 year (inclusive) before the expiry of the three -year validity period. No renewal application will be accepted outside of this submission window."
• Clause 8.2.2 (New) is added. This new clause states: "Applicants shall submit a new application if the importer listing has expired."

Suggestions for SOP Updates

• Update SOP section pertaining to importer listing renewal: Review and update any internal procedures or checklists related to the renewal process for importer listings to reflect the revised timeline and the requirement for a new application if the listing expires.
• Communicate changes to relevant personnel: Ensure that all personnel involved in managing importer listings and renewals are aware of the updated requirements in Clause 8.2.1 and the new Clause 8.2.2.

Overview of Changes

The latest version (GN-08:2025(E)) introduces a new section regarding the renewal of listings for local manufacturers.

Key Changes

• New Section 5.6: Renewal of listing: This new section outlines the process and timeline for a listed local manufacturer to apply for the renewal of its listing.
  • Listed local manufacturers must submit a renewal application between 12 weeks and 1 year before the expiry of the current five-year validity period.
  • Applications submitted outside this window will not be accepted.
  • If a local manufacturer listing has expired, applicants must submit a new application.

Suggestions for SOP Updates

• Update SOP Section related to Listing Validity: Incorporate the new requirements for renewal of listing, including the specific submission window before expiry and the consequence of late or expired applications.
• Create a new SOP Sub-section for "Renewal of Listing": This sub-section should detail the steps a local manufacturer needs to take to renew its listing, referencing the 12 weeks to 1 year pre-expiry submission window.
• Update SOP Section on Application Processing: While Section 5.5 of the new version still refers to "The Processing, Approval and Rejection of Applications" and a five-year validity, it needs to be revised to acknowledge the new renewal process. The SOP should clarify that upon successful renewal, the listing continues for another five years. If a new application is submitted after expiry, it will be treated as a fresh application.