I. Purpose
The "Hong Kong and Macao Drug and Device Connect Policy" refers to the use of clinically urgently needed drugs already marketed in Hong Kong and Macao, as well as clinically urgently needed medical devices that have been purchased and used by public hospitals in Hong Kong and Macao and possess clinical application advancement, in designated medical institutions within the Guangdong-Hong Kong-Macao Greater Bay Area. In December 2025, Heyou Pinnacle Medical Center was officially designated as one of the fourth batch of designated medical institutions in the Greater Bay Area to implement the "Hong Kong and Macao Drug and Device Connect Policy," allowing the use of clinically urgently needed imported drugs and devices from Hong Kong and Macao introduced through this policy.
To standardize the ethics review work for the "Hong Kong and Macao Drug and Device Connect Policy" at our institution, meet clinical medication and device needs, and ensure patient safety, the Medical Ethics Committee of our institution has formulated these guidelines based on relevant policies, regulations, and local practical experience.
These guidelines apply to the ethics review work for urgently needed drugs and devices from Hong Kong and Macao conducted at Heyou Pinnacle Medical Center, a designated medical institution verified by the health authority of the Guangdong Provincial People's Government for the import and use of clinically urgently needed imported drugs and medical devices from Hong Kong and Macao (hereinafter referred to as urgently needed Hong Kong and Macao drugs and devices). Real-world studies on urgently needed Hong Kong and Macao drugs and devices must apply for ethics review in accordance with the relevant requirements for research projects.
II. Definitions
Clinically Urgently Imported Medicines from Hong Kong and Macao: According to Article 2 of the Regulations, clinically urgently imported medicines from Hong Kong and Macao refer to clinically urgently needed medicines that are already marketed in Hong Kong and Macao and are imported for use by designated medical institutions in the nine mainland cities. Therefore, clinically urgently imported medicines from Hong Kong and Macao must meet two requirements: first, they must be clinically urgently needed; second, they must already be marketed in Hong Kong and Macao.
Clinically Urgently Imported Medical Devices from Hong Kong and Macao: According to Article 2 of the Regulations, clinically urgently imported medical devices from Hong Kong and Macao refer to clinically urgently needed medical devices that have been purchased and used by public hospitals in Hong Kong and Macao, possess clinical application advancement, and are imported for use by designated medical institutions in the nine mainland cities. Therefore, clinically urgently imported medical devices from Hong Kong and Macao must meet three requirements: first, they must be clinically urgently needed; second, they must have been purchased and used by public hospitals in Hong Kong and Macao; third, they must possess clinical application advancement.
III. Categories of Ethics Review
(A) Initial Review
1. Before the first application for use of urgently needed Hong Kong and Macao drugs and devices in a medical institution, an initial ethics review application must be submitted to the Ethics Committee in accordance with the requirements of the initial review application materials list. Implementation may proceed only after approval by the Ethics Committee. Specific materials for the initial review application include: Initial Review Application for Clinically Urgently Imported Drugs and Medical Devices from Hong Kong and Macao, Expert Committee Opinion on the "Hong Kong and Macao Drug and Device Connect Policy," Informed Consent Form, Safety Prevention Measures and Risk Monitoring and Disposal Plan, Qualification Certificates of the Business Enterprise for Procurement, Import, and Distribution, Instructions for Use of Drugs/Medical Devices, Drug/Medical Device Instructions, Basic Information Form for Designated Medical Institutions Applying for Import and Use of Urgently Needed Drugs/Medical Devices from Hong Kong and Macao, Basic Situation Form for Designated Medical Institutions Applying for Import and Use of Urgently Needed Drugs/Medical Devices from Hong Kong and Macao, Target Patient Indications and Scope of Application, Follow-up Plan Document, Diagnosis and Treatment Guidelines and Standards, Valid Approval Certificate Issued by the Official Authority of Hong Kong or Macao to the Marketing Authorization Holder Allowing Market Launch, Statement from the Overseas/Hong Kong and Macao Marketing Authorization Holder or Its Designated Agent in China Confirming the Product Is Still Within the Validity Period of Market Launch in Hong Kong and Macao, Relevant Information from Public Medical Institutions in Hong Kong and Macao Demonstrating the Procurement and Use of the Product (Applicable Only to Medical Devices), Project Team Member List, Project Team Member Qualification Certificates, and Other Documents Required for Ethics Review.
New indications and newly authorized departments for urgently needed Hong Kong and Macao drugs and devices shall be processed as initial review applications.
Newly authorized prescribing personnel must hold a title of associate senior or above. If the scope of practice in their physician practice certificate does not correspond to the specialty of the approved urgently needed Hong Kong and Macao drugs and devices, or if their organizational affiliation is not within the authorized department, the application shall be processed as an initial review.
Situations involving taking medication out of the hospital must be stated during the initial review.
2. The Ethics Committee shall conduct a comprehensive review of the urgency, advancement, safety, and ethical rationality of the clinical application of urgently needed Hong Kong and Macao drugs and devices based on the review elements in the "Initial Review Evaluation Form - Drug and Device Connect."
3. Review Elements:
(1) Whether the target patient indications are appropriate;
(2) Whether the scope of application and scope of use are appropriate;
(3) Whether the follow-up plan is appropriate;
(4) Whether risks have been fully assessed and whether preventive measures and emergency plans are adequate;
(5) Whether the qualifications of project team members meet the requirements;
(6) Whether the information provided to patients or their guardians is complete and understandable;
(7) Informing patients or their guardians about the collection, storage, use, and confidentiality regulations of personal and medical information, and the possibility of use in basic and commercial research;
(8) Whether the method of obtaining informed consent is appropriate;
(9) Having provisions for listening to and addressing patients' questions and opinions during the diagnosis and treatment process;
(10) Other ethical considerations involving patients.
4. Review Decisions: Approval, Approval with Modifications, Re-review after Modifications, Disapproval.
(B) Follow-up Review
1. Types of Follow-up Review: Includes amendment review, annual/periodic follow-up review, safety information review, and project completion review.
2. Review Decisions for Follow-up Review: Approval, Approval with Modifications, Re-review after Modifications, Disapproval.
3. Amendment Review:
After ethics review approval for the import and use of urgently needed Hong Kong and Macao drugs and devices, modifications to the informed consent form and instructions for use of drugs/medical devices, or modifications to the informed consent form, instructions for use of drugs/medical devices, and other related documents due to new serious adverse reactions or black box warnings in the marketing authorization in Hong Kong and Macao, must be approved by the Ethics Committee before implementation. Specific materials for the amendment review application include: Amendment Review Application, Amendment Explanation, Revised Informed Consent Form, Instructions for Use of Drugs/Medical Devices, or Other Related Documents.
The Ethics Committee shall review based on the review elements in the "Research Protocol Amendment Application Form - Drug and Device Connect," which specifically include:
(1) For modifications to eliminate urgent harm to patients, assess the impact of the urgent harm;
(2) Whether it increases patient risk;
(3) Whether it reduces patient benefit;
(4) Whether there is new information that may affect the patient's consent to continue use;
(5) Whether the informed consent form and related information materials are complete and understandable;
(6) Whether it is necessary to re-obtain informed consent from the patient;
(7) Whether the criteria for ethics review approval for the import and use of urgently needed Hong Kong and Macao drugs and devices continue to be met.
4. Annual/Periodic Follow-up Review: If the product import and use results are satisfactory, and the certificate holder, manufacturer, product name, and model remain unchanged, a project progress report may be submitted one month before the expiration of the ethics review approval document to request an extension of the approval document's validity. Additionally, a project progress report must be submitted one month before the expiration of the follow-up review frequency determined by the Ethics Committee. During project implementation, the Ethics Committee shall dynamically assess risks and benefits to determine whether the follow-up review frequency needs adjustment. Specific materials for the project progress report include: Project Progress Report, Summary of Safety Information Reports, and Other Related Documents.
The Ethics Committee shall review based on the review elements in the "Annual/Periodic Follow-up Review Form - Drug and Device Connect," which specifically include:
(1) Whether changes or new information that increase patient risk are acceptable;
(2) Whether the risk-benefit ratio is reasonable;
(3) Whether the criteria for ethics review approval for the import and use of urgently needed Hong Kong and Macao drugs and devices continue to be met.
5. Safety Information Review: If a new serious adverse reaction occurs during the use of urgently needed Hong Kong and Macao drugs and devices in the medical institution, it must be reported to the Ethics Committee for review within 15 days of the physician's knowledge. If the new serious adverse reaction involves a death case or a cluster event, it must be reported to the Ethics Committee for review within 24 hours of the physician's knowledge. Specific materials for the safety information report include: Safety Information Report, Adverse Reaction Report (generated by the Guangdong Drug Alert and Control System), and Other Related Documents.
The Ethics Committee shall review based on the review elements in the "Safety Information Review Form - Drug and Device Connect," which specifically include:
(1) Whether the reported safety information has sufficient evidence to demonstrate an increase in patient risk;
(2) Whether the patient's subsequent medical care and follow-up arrangements are appropriate;
(3) Whether there is new information that may affect the patient's willingness to continue using urgently needed Hong Kong and Macao drugs and devices;
(4) Whether it is necessary to modify the informed consent form;
(5) Whether it is necessary to re-obtain informed consent;
(6) Whether the risk-benefit ratio is reasonable;
(7) Whether the criteria for ethics review approval for the import and use of urgently needed Hong Kong and Macao drugs and devices continue to be met.
6. Project Completion Review: Upon the conclusion of the use of urgently needed Hong Kong and Macao drugs and devices (e.g., upon approval for domestic marketing), a project completion report must be submitted. Specific materials for the project completion report include: Project Completion Report and Other Related Documents.
The Ethics Committee shall review based on the review elements in the "Project Completion Review Worksheet for Clinically Urgently Imported Drugs and Medical Devices from Hong Kong and Macao," which specifically include:
(1) Whether there are issues affecting patient rights;
(2) Whether there are unresolved adverse reactions/events, such as patients with related injuries who have not yet recovered.
(C) Re-review
1. After initial review and follow-up review, if the ethics review opinion is "Approval with Modifications" or "Re-review after Modifications," the application materials must be revised and resubmitted as a "Re-review Application." Implementation may proceed only after approval by the Ethics Committee. If there are differing views on the ethics review opinion, a "Re-review Application" may be submitted to appeal the differing views and request the Ethics Committee to reconsider its decision. Specific materials for the re-review include: Re-review Application, Amendment Explanation, Revised Informed Consent Form, Instructions for Use of Drugs/Medical Devices, or Other Related Documents.
2. The Ethics Committee shall review based on the review elements in the "Re-review Worksheet for Clinically Urgently Imported Drugs and Medical Devices from Hong Kong and Macao."
3. Review Elements: (1) No objection to the requirements of the ethics review opinion: Verify the modifications to the submitted documents item by item, confirming that modifications have been made as required by the ethics opinion. (2) Objection to the requirements of the ethics review opinion: Assess whether the objection or clarification regarding the ethics review opinion can be accepted based on the criteria for ethics review approval.
IV. Ethics Review Process
(A) Application
The Ethics Committee shall publish a clear review workflow and application requirements. Urgently needed Hong Kong and Macao drugs and devices must first undergo review by the relevant departments of the medical institution for urgency, advancement, and safety. After passing this review, an ethics review application shall be submitted as required.
(B) Acceptance
The secretary shall conduct a formal review of the submitted application materials. If the documents are complete and meet the requirements, the application shall be accepted. If the materials are incomplete, the applicant shall be notified at once to supplement or revise them.
(C) Processing
The review method shall be determined based on the nature and risk of the project, and committee members with relevant professional backgrounds shall be selected as primary reviewers. When necessary, independent consultants may be invited to provide advisory opinions on specific issues.
(D) Review
The Ethics Review Committee shall conduct project review in accordance with the requirements of the procedures for each type of review method.
(E) Decision
Types of decision opinions may include: Approval, Approval with Modifications, Re-review after Modifications, Disapproval.
(F) Communication
The time from acceptance of the submitted materials to the issuance of the ethics review decision document shall generally not exceed 30 days. For emergency meeting reviews, the time shall generally not exceed 7 days. For emergency reviews of public health emergencies such as disease outbreaks, the time shall generally not exceed 72 hours.
V. Ethics Review Methods
(A) Classification
1. Based on the form of review, review methods are divided into:
Meeting Review: A review method in which committee members present meet the quorum, discuss, vote, and decide on urgently needed Hong Kong and Macao drug and device projects in a meeting setting, providing opinions and suggestions. This is the primary review method for ethics review.
Emergency Meeting Review: A review method in which the Ethics Committee convenes an emergency meeting to discuss, vote, and decide on major or serious issues that endanger patient life safety during implementation, providing opinions and suggestions.
Expedited Review: A review method in which one or more committee members are designated to conduct an ethics review of urgently needed Hong Kong and Macao drug and device projects. The review results are reported at the next meeting. This is a non-meeting review method relative to meeting review.
2. The procedures for each type of review method shall follow the regulations for routine project ethics review operations.
(B) Applicable Scenarios
1. The following scenarios are applicable to meeting review:
(1) For urgently needed Hong Kong and Macao drugs and devices applied for import use by a designated medical institution, as well as new indications, if no other medical institution has previously applied for their use, the initial review application shall generally be conducted via meeting review.
(2) For amendment review applications involving modifications to avoid urgent harm to patients, modifications that increase patient risk, or modifications that significantly affect the approval for import use of urgently needed Hong Kong and Macao drugs and devices, meeting review may be used.
(3) For project progress reports involving changes or new information that increase patient risk or significantly affect the approval for import use of urgently needed Hong Kong and Macao drugs and devices, meeting review may be used.
(4) When there is sufficient evidence that the reported safety information increases patient risk or significantly affects the approval for import use of urgently needed Hong Kong and Macao drugs and devices.
(5) For re-review applications where the ethics review opinion was "Re-review after Modifications" and the project is resubmitted.
(6) For re-review applications where the ethics review opinion was "Approval with Modifications," but the applicant did not make modifications as required by the ethics opinion and provided an explanation, and the Ethics Committee members deem it necessary to submit the project for meeting review.
2. The following scenarios are applicable to expedited review:
(1) For urgently needed Hong Kong and Macao drugs and devices applied for import use by a designated medical institution, if another medical institution has previously applied for their use, as well as for newly authorized departments and prescribing personnel, the initial review shall generally be conducted via expedited review.
(2) For amendment review applications involving modifications that do not increase patient risk or do not significantly affect the approval for import use of urgently needed Hong Kong and Macao drugs and devices, or minor modifications, expedited review may be used.
(3) For project progress reports without changes or new information that increase patient risk or significantly affect the approval for import use of urgently needed Hong Kong and Macao drugs and devices, expedited review may be used.
(4) When there is insufficient evidence that the reported safety information increases patient risk or affects the approval for import use of urgently needed Hong Kong and Macao drugs and devices.
(5) Project completion reports shall generally be reviewed via expedited review.
(6) For re-review applications where the ethics review opinion was "Approval with Modifications," and the project is resubmitted after modifying the plan in accordance with the Ethics Committee's review opinion.
3. The following scenarios are applicable to emergency meeting review: Major issues endangering patient life safety. Emergency situations such as public health emergencies requiring an urgent ethics review meeting.
VI. References
1. The 11th Meeting of the Standing Committee of the 14th Guangdong Provincial People's Congress. Regulations of the Guangdong-Hong Kong-Macao Greater Bay Area on the Administration of Imported Drugs and Medical Devices from Hong Kong and Macao in the Nine Mainland Cities [EB/OL]. (2024-07-31) [2025-09-12]. http：//www. gd. gov. cn/ gdywdt/zwzt/ygadwq/zxzc/content/post_4467193.html.
2. Guangdong Provincial Drug Administration, Guangdong Provincial Health Commission. Notice on Issuing the Application Guidelines for Imported Drugs and Medical Devices from Hong Kong and Macao in the Nine Mainland Cities of the Guangdong-Hong Kong-Macao Greater Bay Area [EB/OL]. (2024-12-26) [2025-09-12]. http：//mpa. gd. gov. cn/ zwfw/wjxz/ywsldt/content/post_4644522. html.
VII. Attachments
1.Initial Review Application Form - Drug and Device Connect (B-3-2)
2. Initial Review Evaluation Form - Drug and Device Connect (B-7-3)
3. Re-review Worksheet for Clinically Urgently Imported Drugs and Medical Devices from Hong Kong and Macao (B-9-2)
4. Research Protocol Amendment Application Form - Drug and Device Connect (B-12-1)
5. Follow-up Review Evaluation Form - Drug and Device Connect (B-15-1)
6. Project Completion Review Worksheet for Clinically Urgently Imported Drugs and Medical Devices from Hong Kong and Macao (B-16-2)
7. Safety Information Review Worksheet - Drug and Device Connect (B-46)
