The Provincial Government's "Regulations on the Management of Urgently Imported Drugs and Medical Devices in the Boao Lecheng International Medical Tourism Pilot Zone of Hainan Free Trade Port"

Qiongfu [2023] No. 16

People's Governments of all cities, counties, and autonomous counties, and all units directly under the provincial government:

The "Regulations on the Management of Urgently Imported Drugs and Medical Devices in the Boao Lecheng International Medical Tourism Pilot Zone of Hainan Free Trade Port" are now issued to you. Please implement them conscientiously.

People's Government of Hainan Province

March 25, 2023

(This document is disclosed voluntarily)

Regulations on the Management of Urgently Imported Drugs and Medical Devices in the Boao Lecheng International Medical Tourism Pilot Zone of Hainan Free Trade Port

Chapter I General Article 1  In order to strengthen the supervision and management of clinically urgently needed imported drugs and medical devices (hereinafter referred to as clinically urgently needed imported drugs and medical devices) in the Boao Lecheng International Medical Tourism Pilot Zone of Hainan Free Trade Port (hereinafter referred to as the Pilot Zone) and ensure the safety of drugs and medical devices, these regulations are formulated in accordance with the "Drug Administration Law of the People's Republic of China", "Medical Device Supervision and Management Regulations", "Decision of the State Council on Suspending the Implementation of the Relevant Provisions of the "Medical Device Supervision and Management Regulations" in the Boao Lecheng International Medical Tourism Pilot Zone of Hainan" (Guofa [2018] No. 10), "Decision of the State Council on Temporarily Adjusting the Implementation of the Relevant Provisions of the "Regulations on the Implementation of the Drug Administration Law of the People's Republic of China" in the Boao Lecheng International Medical Tourism Pilot Zone of Hainan" (Guofa [2018] No. 43), and the "Implementation Plan on Supporting the Construction of the Boao Lecheng International Medical Tourism Pilot Zone" (Fagai District [2019] No. 1482) jointly issued by the National Development and Reform Commission, the National Health and Health Commission, the State Administration of Traditional Chinese Medicine, and the State Food and Drug Administration.

Article 2  Clinically urgently needed imported drugs in these Regulations refer to drugs (excluding vaccines) that have been approved for marketing abroad and have not been approved for registration in my country and cannot be replaced by domestically marketed products due to clinical urgent needs.

Clinically urgently needed imported medical devices in these Regulations refer to medical devices that have been approved for marketing abroad and have no similar products approved for registration in my country and that are imported by medical institutions in the pilot zone due to clinical urgent needs.

Clinically urgently needed imported drugs and devices should be used for specific medical purposes in designated medical institutions (hereinafter referred to as designated medical institutions) where they are applied for use.

Article 3  The provincial health and health management department, the provincial drug supervision and administration department, Haikou Customs, the pilot zone management department and other units shall perform relevant management responsibilities for medical institutions in the pilot zone and clinically urgently needed imported drugs and devices in accordance with relevant laws and regulations and these Regulations.

The Medical and Drug Supervision and Administration Bureau of the Hainan Boao Lecheng International Medical Tourism Pilot Zone (hereinafter referred to as the Lecheng Pharmaceutical Supervision Bureau) is responsible for the management of clinically urgently needed imported drugs and devices within the scope of its duties. The provincial health and health management department and the provincial drug supervision and administration department shall assess the management of clinically urgently needed imported drugs and devices by the Lecheng Pharmaceutical Supervision Bureau.

Article 4 Designated medical institutions shall bear the main responsibility for the safety risks of using urgently needed imported drugs and medical devices.

Article 5 If the real-world data generated by urgently needed imported drugs and medical devices meet the relevant requirements for registration and application of drugs and medical devices in my country, the registration applicant may use it as application materials.

Chapter II Application and Approval

Article 6 Designated medical institutions shall meet the following conditions:

(i) Obtain a medical institution practice license in accordance with the law, have the capacity of a Class A tertiary hospital, and have professional departments that are suitable for the application for the use of urgently needed imported drugs and medical devices;

(ii) Have guarantee measures and management systems for circulation, transportation and storage that meet the characteristics and instructions of urgently needed imported drugs and medical devices;

(iii) Set up a drug and medical device adverse reaction/event monitoring agency, equip full-time personnel and have received professional training, and can correctly perform the duties of adverse reaction/event monitoring;

(iv) Have emergency plans and disposal capabilities for serious adverse reactions/events that may occur in urgently needed imported drugs and medical devices.

Article 7  The provincial health and health management department is responsible for conducting qualification assessment and review of medical institutions that apply for the use of urgently needed imported drugs and medical devices. Medical institutions can apply for assessment by department according to their own departmental capabilities. After accepting the application, the provincial health and health management department shall make a decision within 10 working days on whether to approve the use of urgently needed imported drugs and medical devices.

Article 8  The department or medical team that uses urgently needed imported drugs and medical devices shall have the domestic leading level in the application field of such products. The corresponding personnel shall obtain the qualification to practice in the designated medical institutions in the pilot zone in accordance with the law, have a full understanding of the urgently needed imported drugs and medical devices applied for, and be able to use them correctly and reasonably.

Article 9  The designated medical institution shall submit an application for the use of urgently needed imported drugs and medical devices on the traceability management platform of urgently needed imported drugs and medical devices in accordance with the requirements of the application guidelines on the basis of evaluating the advancedness, effectiveness and controllable risks of the use of urgently needed imported drugs and medical devices in clinical practice on the basis of evaluating the advancedness, effectiveness and controllable risks of the use of urgently needed imported drugs and medical devices in clinical practice on the traceability management platform of urgently needed imported drugs and medical devices in clinical practice, and promise that the application materials are legal, true, accurate and traceable, and the urgently needed imported drugs and medical devices applied for are only used in this medical institution. The application guidelines and related requirements shall be separately formulated by the provincial drug supervision and administration department.

Article 10  After accepting the application for the use of clinically urgently needed imported drugs and medical devices submitted by designated medical institutions, the provincial health and health management department shall evaluate whether the drugs and medical devices are clinically urgently needed and whether the medical institution department or medical team has the ability to use them, and shall issue an evaluation opinion within 5 working days. The evaluation procedure shall be separately formulated by the provincial health and health management department.

After accepting the application for the use of clinically urgently needed imported drugs and medical devices submitted by designated medical institutions based on the evaluation opinion of the provincial health and health management department, the provincial drug supervision and administration department shall focus on reviewing the overseas listing of the products, the occurrence of adverse reactions/events, etc., and shall apply for administrative approval within 7 working days. The handling procedure shall be separately formulated by the provincial drug supervision and administration department.

Article 11 After the product obtains the drug and medical device registration certificate, it shall no longer be approved for import as clinically urgently needed imported drugs and medical devices.

Chapter III Import customs clearance and circulation management

Article 12  The port drug supervision and administration department shall handle the import registration procedures for the designated medical institutions in accordance with the relevant regulations based on the approval documents of the provincial drug supervision and administration department. Haikou Customs shall handle the customs clearance procedures for clinically urgently needed imported drugs and medical devices in accordance with regulations, and support the electronic customs clearance of clinically urgently needed imported drugs and medical devices.

Article 13: Urgently imported drugs for clinical use do not require import inspection. Items listed in the "List of Corresponding Names and Commodity Numbers for Customs Inspection and Quarantine of Special Items" shall be subject to administrative licensing in accordance with relevant customs regulations.

It is prohibited to import expired, invalid, obsolete, refurbished and used medical devices or transfer medical devices in use from foreign medical institutions.

Article 14  Designated medical institutions shall entrust drug dealers holding "Drug Business License" to purchase, import and distribute urgently needed imported drugs for clinical use; they shall entrust medical device dealers holding "Medical Device Business License" to purchase, import and distribute urgently needed imported medical devices for clinical use.

Article 15  The entrusted drug and device dealers (hereinafter referred to as the entrusted dealers) shall conduct business within the scope of the business license, purchase, store and distribute urgently needed imported drugs and devices for clinical use in accordance with the requirements of the business quality management specifications, and shall be responsible for the quality and safety of the business of urgently needed imported drugs and devices for clinical use, and establish a drug and device adverse reaction/event reporting system as required.

The entrusted operating enterprise shall purchase the imported drugs and medical devices urgently needed in clinical practice from the marketing authorization holder/registrant or its authorized institution (hereinafter referred to as the supplier); if purchased from other channels, it shall prove that the purchased imported drugs and medical devices urgently needed in clinical practice are the products of the marked enterprise.

Chapter IV Use Management

Article 16 Designated medical institutions and entrusted operating enterprises shall strengthen the quality management of imported drugs and medical devices urgently needed in clinical practice to ensure that the risks of drugs and medical devices are controllable, the sources are legal, the storage is standardized, and the destination is clear.

Article 17 Designated medical institutions and entrusted operating enterprises shall sign a quality agreement with the supplier to clarify the quality responsibilities of all parties when purchasing imported drugs and medical devices urgently needed in clinical practice.

Designated medical institutions and entrusted operating enterprises shall keep the relevant certification documents, transaction bills, purchase records and acceptance records of imported drugs and medical devices urgently needed in clinical practice for 3 years after the expiration date of imported drugs and medical devices urgently needed in clinical practice; the storage period for medical devices without a clear expiration date shall not be less than 5 years; the relevant documents and records of implantable medical devices shall be permanently preserved.

Designated medical institutions and entrusted operating enterprises shall transport, store and maintain according to the requirements of the instructions.

Article 18  Before using, designated medical institutions shall inform patients or their families that urgently needed imported drugs and medical devices are approved for urgent clinical import, that domestically marketed products cannot be substituted, or that treatment plans are not available, and shall sign informed consent and other documents with patients or their families.

Article 19 Designated medical institutions shall accept the guidance of the marketing authorization holder/registrant or supplier, and use urgently needed imported drugs and medical devices correctly and reasonably according to the approved indications and product instructions abroad.

Designated medical institutions shall take effective measures to ensure that urgently needed imported drugs and medical devices are only used for specific medical purposes of the medical institution, preserve clinical diagnosis and treatment records and data related to the use of urgently needed imported drugs and medical devices, follow up and observe each case, conduct clinical use effect evaluation every quarter, and report the evaluation results in writing to the Lecheng Medical and Pharmaceutical Regulatory Bureau, the Provincial Health and Health Administration Department, and the Provincial Drug Supervision and Administration Department.

Designated medical institutions shall, based on the patient's diagnosis and treatment needs and product characteristics, after full evaluation, and on the premise of ensuring safety and effectiveness, patients may take away urgently needed imported drugs and medical devices for their own use only, in reasonable quantities, and with controllable risk levels. Relevant management measures will be formulated separately.

Article 20  Departments and medical teams of designated medical institutions shall ensure that they continue to have the prescribed conditions and capabilities. If they no longer have the conditions, they shall proactively stop importing and/or using urgently needed imported drugs and medical devices, and report to the Lecheng Medical and Pharmaceutical Regulatory Bureau.

Article 21  Designated medical institutions shall formulate comprehensive safety precautions and risk management plans. When a safety incident of urgently needed imported drugs and medical devices occurs, designated medical institutions shall activate emergency plans in accordance with regulations, take reasonable safety precautions, control risks, and ensure the safety of patients' use of drugs and medical devices.

Article 22  Designated medical institutions shall establish a reporting and monitoring system for adverse reactions/events of urgently needed imported drugs and medical devices, actively monitor urgently needed imported drugs and medical devices, and report adverse reactions/events that may be related to urgently needed imported drugs and medical devices to the Lecheng Medical and Pharmaceutical Regulatory Bureau, the provincial health and health management department, and the provincial drug supervision and management department as required.

Article 23  Designated medical institutions shall pay attention to the use of urgently needed imported drugs and medical devices abroad. If the designated medical institution discovers or learns that the instructions for clinically urgently needed imported drugs and medical devices have been revised abroad, safety risk warnings have been issued, major safety incidents have occurred, or the use of imported drugs and medical devices has been suspended, etc., which affects the safety of the use of clinically urgently needed imported drugs and medical devices, it shall take measures such as adjusting the use plan, suspending use, and stopping procurement, depending on the situation, and promptly report to the Lecheng Medical and Pharmaceutical Regulatory Bureau and the drug adverse reaction monitoring department of the pilot zone.

Article 24  If clinically urgently needed imported drugs and medical devices are required to be recalled abroad, the designated medical institution shall immediately stop using them and notify the entrusted operating enterprise; the entrusted operating enterprise shall immediately stop distribution and implement the recall in accordance with the relevant provisions on the recall of clinically urgently needed imported drugs and medical devices. If the supplier finds that a major safety risk needs to be recalled, it shall notify the designated medical institution to immediately stop using them and take the initiative to recall them.

The designated medical institution and the entrusted operating enterprise shall promptly report the recall and handling situation to the Lecheng Medical and Pharmaceutical Regulatory Bureau, and the Lecheng Medical and Pharmaceutical Regulatory Bureau shall promptly report major safety risk events to the provincial health and health management department and the provincial drug supervision and management department.

Article 25  Designated medical institutions, entrusted operating enterprises, and bonded warehouses in the pilot zone shall use the traceability management platform for clinically urgently needed imported drugs and medical devices established by the provincial drug supervision and administration department in conjunction with the management department of the pilot zone to manage clinically urgently needed imported drugs and medical devices, formulate an information-based traceability system, and continuously improve the information-based traceability system to ensure that the entire process of application, procurement, import, distribution, use, and adverse reaction/event monitoring of clinically urgently needed imported drugs and medical devices can be traced, ensure that the source can be checked and the destination can be traced, and bear the corresponding responsibility for drug quality and safety in accordance with the law.

Article 26  Designated medical institutions shall conduct safety and effectiveness evaluation of the use of clinically urgently needed imported drugs and medical devices, and report the evaluation results, changes in basic conditions such as medical institution personnel and capabilities to the Lecheng Medical and Pharmaceutical Regulatory Bureau every year.

The Lecheng Medical and Pharmaceutical Regulatory Bureau shall submit the annual summary to the provincial health and health management department and the provincial drug supervision and administration department.

Chapter V Supervision and Management

Article 27  The provincial health and health management department and the provincial drug supervision and management department shall guide the Lecheng Medical and Pharmaceutical Supervision Bureau to conduct routine supervision and inspection on designated medical institutions. If it is found that the designated medical institutions no longer have the conditions and capabilities to use clinically urgently needed imported drugs and medical devices, they shall be ordered to stop importing and/or using clinically urgently needed imported drugs and medical devices. The Lecheng Medical and Pharmaceutical Supervision Bureau shall guide medical institutions to properly dispose of clinically urgently needed imported drugs and medical devices in stock.

Article 28  The provincial health and health management department and the provincial drug supervision and management department shall organize the management of the import, circulation and use of relevant drugs and medical devices. If there are special management requirements for laws and regulations such as anesthetic drugs, they shall be implemented in accordance with relevant requirements and prevent abuses; conduct risk assessments for clinically urgently needed imported drugs and medical devices that have serious adverse reactions/incidents and may have major safety risks, and take necessary control measures.

For clinically urgently needed imported drugs and medical devices that cause harm to the human body and there is evidence that they may endanger human health, the provincial drug supervision and management department may take emergency control measures to order the suspension of import and use. If it decides to terminate import and use, the provincial drug supervision and management department shall promptly notify Haikou Customs.

Article 29 If a designated medical institution needs to destroy expired, damaged or scrapped imported drugs and medical devices urgently needed for clinical use, it shall apply to the Lecheng Medical and Pharmaceutical Regulatory Bureau for supervised destruction.

Article 30  If the use of imported drugs and medical devices urgently needed for clinical use causes harm to patients, the designated medical institution shall bear liability in accordance with relevant regulations. If the harm is caused by imported drugs and medical devices urgently needed for clinical use, the designated medical institution shall first compensate and then seek compensation from the relevant responsible units in accordance with the law or agreement.

Designated medical institutions are encouraged to introduce insurance mechanisms and purchase medical commercial insurance.

Article 31  The provincial health and health management department shall take measures such as warnings, responsibility talks, orders to rectify within a time limit, and suspension of use if the designated medical institution fails to reasonably deal with the use of drugs and medical devices in response to the overseas use warnings and recalls of imported drugs and medical devices urgently needed for clinical use.

Article 32  The provincial drug supervision and administration department shall take measures such as warnings, responsibility talks, orders to rectify within a time limit, and suspension of use if the entrusted operating enterprise fails to purchase, store and distribute imported drugs and medical devices urgently needed for clinical use in accordance with the requirements of the business quality management specifications.

The provincial drug supervision and administration department, together with the provincial health and health administration department, shall take measures such as warnings, accountability talks, orders to rectify within a time limit, and suspension of use in the following circumstances:

(i) The designated medical institution is not equipped with full-time personnel and has not established an adverse reaction/event reporting and monitoring system;

(ii) The designated medical institution fails to take timely measures to eliminate the quality and safety risks in the use of urgently needed imported drugs and equipment.

Article 33 The Lecheng Medical and Pharmaceutical Regulatory Bureau shall take measures such as warnings, accountability talks, orders to rectify within a time limit, and suspension of use in the following circumstances:

(i) The designated medical institution fails to keep the relevant certification documents, transaction bills, purchase and acceptance records, medical records and data of urgently needed imported drugs and equipment in accordance with the regulations, and fails to use, store and maintain urgently needed imported drugs and equipment in accordance with the instructions;

(ii) The designated medical institution fails to use urgently needed imported drugs and equipment in accordance with the approved purpose and requirements, and fails to inform patients or their families before the use of urgently needed imported drugs and equipment that the products are approved for urgent clinical imports and cannot be replaced by domestically marketed varieties or

treatment plans, etc.;

(III) The designated medical institution fails to carry out the monitoring of adverse reactions/events of urgently needed imported drugs and medical devices and the relevant disposal measures for overseas use warnings and recalls as required;

(IV) The designated medical institution fails to make an annual report on the safety and effectiveness evaluation of the use of urgently needed imported drugs and medical devices;

(V) The channels through which the entrusted operating enterprise purchases urgently needed imported drugs and medical devices cannot be traced;

(VI) The entrusted operating enterprise fails to keep the relevant certification documents, transaction bills, purchase and acceptance records of urgently needed imported drugs and medical devices as required, and fails to transport, store and maintain urgently needed imported drugs and medical devices as required by the instructions.

Article 34  If the designated medical institution or entrusted operating enterprise engages in other illegal and irregular acts such as fraud in the import and use of urgently needed imported drugs and medical devices, the provincial health and health management department, the provincial drug supervision and management department, the Haikou Customs, etc. shall handle it in accordance with relevant laws and regulations.

Chapter VI Supplementary Provisions

Article 35 These Regulations shall be interpreted by the Hainan Provincial People's Government.

Article 36  These Regulations shall come into force on May 1, 2023. The "Interim Provisions on the Management of Clinically Urgently Imported Drugs in the Boao Lecheng International Medical Tourism Pilot Zone of Hainan" (Qiong Fu [2019] No. 16) issued by the People's Government of Hainan Province on April 2, 2019 and the "Regulations on the Management of Clinically Urgently Imported Medical Devices in the Boao Lecheng International Medical Tourism Pilot Zone of Hainan Free Trade Port" (Qiong Fu [2020] No. 28) issued on June 2, 2020 are hereby repealed at the same time.