Document of the People's Government of Hainan Province

Q.F. [2023] No.16

Circular of the People's Government of Hainan Province on Issuing the Administrative Rules for Drugs and Medical Devices in Urgent Need for Clinical Use Imported by the Boao Lecheng International Medical Tourism Pilot Zone in the Hainan Free Trade Port

To the people's governments of all cities, counties, and autonomous counties; and units directly under the provincial government:

The "Administrative Rules for Drugs and Medical Devices in Urgent Need for Clinical Use Imported by the Boao Lecheng International Medical Tourism Pilot Zone in the Hainan Free Trade Port" is hereby issued to you. Please conscientiously implement the rules earnestly.

                     The People's Government of Hainan Province
March 25, 2023

Administrative Rules for Drugs and Medical Devices in Urgent Need for Clinical Use Imported by the Boao Lecheng International Medical Tourism Pilot Zone in the Hainan Free Trade Port

Chapter 1 General Provisions

Article 1: In order to strengthen the supervision and administration of drugs and medical devices in urgent need for clinical use imported by the Boao Lecheng International Medical Tourism Pilot Zone in the Hainan Free Trade Port (hereinafter referred to as the “pilot zone”) and to ensure the safety of drug and medical devices, these administrative rules are formulated in accordance with the Drug Administration Law of the People's Republic of China, the Regulations for the Supervision and Administration of Medical Devices, the Decision of the State Council on Suspending the Implementation for Relevant Provisions of the Regulations for the Supervision and Administration of Medical Devices in the Hainan Boao Lecheng International Medical Tourism Pilot Zone (G.F. [2018] No. 10), the Decision of the State Council on Temporarily Adjusting the Implementation for Relevant Provisions of the Implementation Regulations of the Drug Administration Law of the People's Republic of China in the Hainan Boao Lecheng International Medical Tourism Pilot Zone (G.F. [2018] No. 43), and the Implementation Plan for Supporting the Development of the Boao Lecheng International Medical Tourism Pilot Zone (F.G.D.Q. [2019] No. 1482) jointly issued by the National Development and Reform Commission, the National Health Commission, the National Administration of Traditional Chinese Medicine, and the National Medical Products Administration. 

Article 2: Covered by the administrative rules, drugs in urgent need for clinical use refer to the ones without being approved for registration that are imported by medical institutions in the pilot zone to fulfill the urgent need for clinical use. The imported drugs must have been approved for marketing abroad, and no approved replacements can be found in China (excluding vaccines).

Covered by the administrative rules, medical devices in urgent need for clinical use refer to the ones that are imported by medical institutions in the pilot zone to fulfill the urgent need for clinical use. The imported medical devices must have been approved for marketing abroad, and no approved replacements can be found in China.

Imported medical products in urgent need for clinical use should only be used for specific medical purposes in the designated medical institutions that have made the application (hereinafter referred to as the “DMIs”).

Article 3: The organs, including the provincial healthcare administration, the provincial medical products administration, Haikou Customs, and the pilot zone administration, should respectively fulfill their administrative responsibilities for the medical institutions in the pilot zone and the imported medical products in urgent need for clinical use, according to the relevant laws, regulations, and the administrative rules,

The Medical Products Administration for the Hainan Boao Lecheng International Medical Tourism Pilot Zone (hereinafter referred to as the “Lecheng Medical Products Administration”) is responsible for administrating imported medical products in urgent need for clinical use within its jurisdiction. The provincial organs relating to healthcare and medical products administration should assess the management of imported medical products in urgent need for clinical use conducted by the Lecheng Medical Products Administration.

Article 4: The DMIs bear the primary responsibility for the safety of imported medical products in urgent need for clinical use.

Article 5: Real-world data generated by imported medical products in urgent need for clinical use can serve as application materials for registration applicants, if they meet relevant requirements for drugs and medical devices registration in China.

Chapter 2: Application and Approval

Article 6: A DMI must meet the following conditions:

(1) It should legally obtain a license, provide services at the level of a grade-A tertiary hospital, and boast specialized departments eligible for imported medical products in urgent need for clinical use.

(2) It should have supporting measures and management systems for imported medical products in urgent need for clinical use in terms of distribution, transportation, and storage based on product characteristics and instructions.

(3) An institution should be established to monitor adverse medical product reactions/events, with dedicated personnel who have undergone professional training, in order to properly fulfill the responsibilities of monitoring adverse reactions/events.

(4) It should have emergency plans and response capability for severe adverse reactions/events relating to imported medical products in urgent need for clinical use.

Article 7: The provincial healthcare administration is responsible for assessing and reviewing medical institutions applying for imported medical products in urgent need for clinical use. Based on the realities, medical institutions may apply for assessments by department. After receiving the application, the provincial healthcare administration should make a decision within 10 working days on whether to permit the use of imported medical products in urgent clinical need.

Article 8: For departments or medical teams utilizing imported medical products in urgent need for clinical use, they should lead China in product application. Legally licensed to work for a DMI in the pilot zone, the relevant personnel should fully understand the imported medical products in urgent need for clinical use they have applied for, and be capable of using them correctly and reasonably.

Article 9: After assessing the advances, efficacy, and safety of imported medical products in urgent need for clinical use, a DMI, in accordance with the requirements of the applying guidelines, should submit relevant applications via the traceability management platform for imported medical products in urgent need for clinical use. It should promise that their application materials feature legality, truthfulness, accuracy, and traceability, and guarantee that the medical products they have applied will only be used on their own. The applying guidelines and related requirements will be formulated by the provincial medical products administration later.

Article 10: After receiving an application for imported medical products in urgent need for clinical use from a DMI, the provincial healthcare administration should assess whether the products are urgently needed for clinical use and if the relevant department or medical team is capable of using them, and provide assessment results within 5 working days. The assessment procedures will be developed by the provincial healthcare administration later.

Based on the assessment results from the provincial healthcare administration, the provincial medical products administration will mainly review the products in terms of overseas marketing and adverse reactions/events, after receiving the application. If approved, an administrative license should be issued within 7 working days. The relevant procedures will be created by the provincial medical products administration later.

Article 11: Once a medical product has obtained a registration certificate for drugs or medical devices, it will no longer be approved for import as a drug or medical device in urgent need for clinical use.

Chapter 3 Import Clearance and Circulation Management

Article 12: The medical products administration corresponding to a port, in accordance with relevant regulations, should make import registration for a DMI, based on the approval documents from the provincial medical products administration. Haikou Customs should complete clearance for imported medical products in urgent need for clinical use in accordance with regulations, supporting the electronic customs clearance.

Article 13: There is no import inspection for imported medical products urgently needed for clinical use. For items involved in the Special Items Corresponding List of Customs Inspection and Quarantine Names and Commodity Numbers, their administrative license are issued in accordance with relevant customs regulations.

It is prohibited to import expired, ineffective, obsolete, reconditioned, or used medical devices, or to transfer medical devices in use from foreign medical institutions.

Article 14: A DMI should entrust licensed pharmaceutical trading enterprises with purchasing, importing, and delivering drugs in urgent need for clinical use. It should also entrust licensed medical device trading enterprises with purchasing, importing, and delivering medical devices.

Article 15: The entrusted medical products trading enterprises (hereinafter referred to as the “entrusted enterprises”) should conduct business within the approved scope. They should purchase, store, and deliver imported medical products urgently needed for clinical use in accordance with the requirements of Good Supply Practice. They should also take responsibility for the supply and safety of the medical products, and establish a system for reporting adverse reactions/events as required.

The entrusted enterprises should purchase imported medical products in urgent need for clinical use from a marketing authorization holder/registrant or its authorized institution (hereinafter referred to as the “supplying enterprises”). If purchased from other sources, they should demonstrate that the medical products bear the identification of the respective enterprise.

Chapter 4: Utilization Management

Article 16：DMIs and entrusted enterprises should enhance the quality management of imported medical products in urgent need for clinical use to ensure the safety, sources, storage, and distribution of the products.

Article 17：When importing medical products in urgent need for clinical use, DMIs, and entrusted enterprises should sign a quality agreement with the supplying enterprise to clarify the quality responsibilities of each party.

DMIs and entrusted enterprises should retain relevant certification documents, transaction notes, purchase records, and acceptance records for 3 years after the medical products have passed their expiry date. For medical devices without a specified expiry date, the retention period should not be less than 5 years. Records related to implanted medical devices should be permanently preserved.

DMIs and entrusted enterprises should transport, store, and maintain medical products based on the requirements of the instructions.

Article 18：Before using the medical products, a DMI should inform patients or their families about the approvals for imported medical products in urgent need for clinical use, the absence of available replacements in China, or treatment protocols. It should also sign informed consent and other relevant documents with patients or their families.

Article 19：A DMI should accept guidance from the marketing authorization holder/registrant or supplying enterprise, and use imported medical products urgently needed for clinical purposes correctly and reasonably based on the indications approved abroad and the instructions.

A DMI should take effective measures to ensure that the imported medical products are used only for its specific medical purposes. It should keep clinical diagnosis and treatment records as well as other data related to the use of the imported medical products, conduct follow-up visits for each patient, and make clinical efficacy evaluations quarterly. Written evaluation results should be submitted to the Lecheng Medical Products Administration, the provincial healthcare administration, and the provincial medical products administration.

After thorough assessment and ensuring safety and efficacy, a DMI, based on patient diagnosis and treatment needs as well as product characteristics, may allow patients to take the imported medical products for personal use, in a reasonable quantity, and with managed risk. Specific management measures will be formulated later.

Article 20：For DMIs, their departments and medical teams should always meet the specified conditions and have relevant capabilities. If they do not, they should stop the import and/or use of relevant medical products in urgent need for clinical use and report to the Lecheng Medical Products Administration.

Article 21：DMIs should develop and refine safety measures and risk response plans. When there is a safety incident concerning imported medical products in urgent need for clinical use, DMIs should initiate emergency plans as required, take reasonable safety measures, manage risks, and ensure the safety of patients using relevant drugs and medical devices.

Article 22：DMIs are required to establish a reporting and monitoring system for adverse reactions/events related to imported medical products in urgent need for clinical use. They should actively monitor the use of the imported medical products, identify potential adverse reactions/events, and report them to the Lecheng Medical Products Administration, the provincial healthcare administration, and the provincial medical products administration.

Article 23：DMIs should pay attention to the overseas use of imported medical products urgently needed for clinical purposes. When noticing there are overseas events with adverse effects on the safety of the medical products, including revisions to the instructions, safety warnings, major safety incidents, or discontinuation, a DMI, based on facts, should take measures, such as adjusting usage plans, suspending the use, and stopping the purchase, and promptly report to the Lecheng Medical Products Administration and the adverse reaction monitoring organ of the pilot zone.

Article 24：If imported medical products in urgent need for clinical use are recalled overseas, DMIs should immediately stop the use of them and notify the entrusted enterprises. The entrusted enterprises should promptly halt distribution and recall the imported medical products according to relevant regulations. If supplying enterprises notice severe safety risks and decide to recall the products, they should inform DMIs to stop using them immediately, and initiate the recalling proactively.

DMIs and entrusted enterprises should promptly submit the details of the recalling and solving efforts to the Lecheng Medical Products Administration which should, in a timely manner, report the events with severe safety risks to the provincial healthcare administration and the provincial medical products administration.

Article 25：DMIs, entrusted enterprises, and bonded warehouses in the pilot zone should manage imported medical products urgently needed for clinical use through the traceability management platform jointly established by the provincial medical products administration and the pilot zone administration. They should create an information-based traceability system, improve the system, and ensure that all stages in the entire process are traceable, including application, purchase, import, distribution, consumption, and adverse reactions/events monitoring. By doing so, they should shoulder their responsibilities for drug quality and safety according to law.

Article 26：DMIs should conduct safety and efficacy evaluations for imported medical products in urgent need for clinical use. They should report to the Lecheng Medical Products Administration every year about the evaluation results, and changes in basic conditions, such as medical institution personnel and relevant capabilities.

The Lecheng Medical Products Administration should submit the annual summary to the provincial healthcare administration and the provincial medical products administration.

Chapter 5  Supervision

Article 27: Guided by the provincial healthcare administration and the provincial medical products administration, the Lecheng Medical Products Administration should conduct routine supervision and inspections for DMIs. If it is found that a DMI no longer meets the conditions for using imported medical products urgently needed for clinical purposes, the institution should be ordered to stop the import and/or use of the products. The Lecheng Medical Products Administration should guide DMIs in disposing of stocked medical products.

Article 28: The provincial healthcare administration and the provincial medical products administration should supervise the import, distribution, and use of relevant imported medical products. For medical products with special management requirements, such as anesthetics, related regulations should be followed, and negative effects should be prevented. For imported medical products urgently needed for clinical use, if the medical products have caused severe adverse reactions/events and may pose major safety risks, a risk assessment should be conducted, and necessary control measures should be taken. 

If imported medical products urgently needed for clinical use are harmful to human bodies and may endanger people’s health, the provincial medical products administration can take emergency measures, such as ordering DMIs to suspend  import and use. If a decision is made to terminate the import and use, the provincial medical products administration should promptly inform the Haikou Customs.

Article 29: DMIs are required to dispose of expired, damaged, or scrapped imported medical products urgently needed for clinical use. They should apply to the Lecheng Medical Products Administration for supervised destruction.

Article 30: If imported medical products urgently needed for clinical use harm patients, the DMI should be held accountable for that according to relevant regulations. For the harmed patients, compensation will be paid by DMIs in advance, and then related entities will be asked for reimbursement according to law or agreements.

DMIs are encouraged to develop insurance mechanisms and to take out commercial medical insurance.

Article 31: If a DMI has not properly disposed of imported medical products urgently needed for clinical use based on the warnings and recalling of the products, the provincial healthcare administration should take measures, including warnings, regulatory talks, orders to modify within the time limit, and suspensions.

Article 32: If an entrusted enterprise has not purchased, stored, and distributed imported medical products urgently needed for clinical use in accordance with the requirements of quality management, the provincial medical products administration should take measures, including warnings, regulatory talks, orders to modify within the time limit, and suspensions.

The measures above-mentioned will be jointly taken by the provincial medical products administration and the provincial healthcare administration, if there are following scenarios:

(1) A DMI has not appointed dedicated personnel, or has not established a reporting and monitoring system for adverse reactions/events.

(2) A DMI has not promptly taken measures to eliminate hidden quality and safety dangers relating to the use of imported medical products urgently needed for clinical purposes.

Article 33: Measures, including warnings, regulatory talks, orders to modify within the time limit, and suspensions, will be taken by the Lecheng Medical Products Administration, if there are following scenarios:

(1) A DMI has not kept records relating to imported medical products urgently needed for clinical use, including relevant certification documents, transaction notes, purchase and acceptance records, as well as diagnosis and treatment records and data, or has not used, stored, and maintained the products according to the instructions.

(2) A DMI has not used the imported medical products based on approved purposes and requirements, or has not informed patients or their families before using the products about the approvals, the absence of available replacements in China, or treatment protocols.

(3) A DMI has not carried out adverse reaction/event monitoring for the imported medical products as required, and has not taken relevant solving measures based on overseas warnings and recalls.

(4) A DMI has not submitted an annual report on the safety and efficacy evaluation of the imported medical products.

(5) The sources of the imported medical products purchased by entrusted enterprises are not traceable.

(6) An entrusted enterprise has not kept records relating to imported medical products urgently needed for clinical use, including relevant certification documents, transaction notes, as well as purchase and acceptance records, and has not transported, stored, and maintained the products according to the instructions.

Article 34: If a DMI or an entrusted enterprise, during processes of importing or using the medical products, engages in fraudulent, illegal and irregular activities, the provincial healthcare administration, the provincial medical products administration, and the Haikou Customs will impose punishments in accordance with relevant laws and regulations.

Chapter 6  Supplementary Articles

Article 35: Notes on these administrative rules are given by the People's Government of Hainan Province.

Article 36: These administrative rules will come into effect on May 1, 2023. The Interim Provisions on the Administration of Imported Drugs Urgently Needed for Clinical Use in the Hainan Boao Lecheng International Medical Tourism Pilot Zone (Q.F. [2019] No. 16) issued by the People's Government of Hainan Province on April 2, 2019, and the Regulations on the Administration of Imported Medical Devices Urgently Needed for Clinical Use in the Boao Lecheng International Medical Tourism Pilot Zone of the Hainan Free Trade Port (Q.F. [2020] No. 28) issued on June 2, 2020, should be simultaneously repealed.

The General Office of the People's Government of Hainan Province  

Issued on March 28, 2023