The Provincial Drug Administration and other departments issued a notice on further optimizing regulatory services to support the high-quality development of Hainan Boao Lecheng International Medical Tourism Pilot Zone.

Qiongyaojian [2021] No. 70

Hainan Boao Lecheng International Medical Tourism Pilot Zone Administration, Boao Lecheng Pilot Zone medical institutions, and all relevant units:

In order to further optimize the business environment of Hainan Boao Lecheng International Medical Tourism Pilot Zone, simplify the approval process for clinically urgently needed imported drugs and medical devices, optimize the approval model, improve the efficiency of regulatory services, facilitate the public to use clinically urgently needed imported drugs and medical devices in a timely manner, and help the high-quality development of Lecheng Pilot Zone. With the approval of the provincial government, the "Several Measures to Further Optimize Regulatory Services to Support the High-Quality Development of Hainan Boao Lecheng International Medical Tourism Pilot Zone" are now issued to you, and will be implemented thirty days after the date of issuance of this notice.

Hainan Provincial Drug Administration   Hainan Provincial Health Commission   Haikou Customs

September 15, 2021

(This document is disclosed voluntarily)

Several measures to further optimize regulatory services and support the high-quality development of Hainan Boao Lecheng International Medical Tourism Pilot Zone

In order to further optimize the business environment of Hainan Boao Lecheng International Medical Tourism Pilot Zone, simplify the approval process for clinically urgently needed imported drugs and medical devices, optimize the approval model, improve the efficiency of regulatory services, facilitate the public to use clinically urgently needed imported drugs and medical devices in a timely manner, and help the high-quality development of Lecheng Pilot Zone. After research, the following measures are formulated:

1. The Hainan Provincial Health and Health Administration is responsible for the qualification assessment and review of medical institutions that apply for the use of clinically urgently needed imported drugs and medical devices, and supports medical institutions to apply for assessment by department according to their own departmental capabilities. Medical institutions that intend to engage in the business of using urgently needed imported drugs and medical devices in clinical practice shall apply to the Hainan Provincial Health and Health Administration and meet the following conditions:

(i) Obtain a medical institution practice license in accordance with the law and have professional departments (including remote diagnosis and treatment medical teams) that are suitable for the urgently needed imported drugs and medical devices applied for;

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

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

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

After accepting the application, the Hainan Provincial Health and Health Administration shall make a decision within ten working days whether to allow the relevant departments of the medical institution to use urgently needed imported drugs and medical devices in clinical practice. Medical institutions that have obtained the qualification to use urgently needed imported drugs and medical devices in clinical practice are called designated medical institutions.

2. Designated medical institutions shall apply for the types and quantities of urgently needed imported drugs and medical devices according to the target indications, submit applications online on the licensed drug and medical device traceability management platform in accordance with the application requirements, and promise that the application materials are legal, true, accurate and traceable, and that urgently needed imported drugs and medical devices are used in this medical institution. Application guidelines will be formulated separately.

3. Hainan Provincial Health and Health Administration and Drug Supervision and Administration Department shall evaluate and review the urgently needed imported drugs and medical devices applied for by designated medical institutions in accordance with their duties.

After accepting the application of the designated medical institution for the use of urgently needed imported drugs and medical devices, the Hainan Provincial Health and Health Administration shall complete the review within three working days, and the Hainan Provincial Drug Supervision and Administration Department shall make an administrative decision on whether to allow the import within seven working days.

After the first approval for the use of urgently needed imported drugs and medical devices in Lecheng Pilot Zone, subsequent applications shall be deemed as non-first time, and the approval shall be implemented by the Lecheng Medical Supervision Department.

4. For urgently needed imported drugs and medical devices with inconsistent management attributes at home and abroad, they shall be managed according to the attributes approved abroad.

5. Designated medical institutions shall entrust pharmaceutical or medical device operating enterprises to purchase, import and distribute clinically urgently needed imported drugs and medical devices.

Entrusted pharmaceutical or medical device operating enterprises (hereinafter referred to as "entrusted operating enterprises") shall hold a "Drug Business License" or "Medical Device Business License".

6. Hainan Provincial Drug Supervision and Administration Department and Haikou Customs shall handle customs clearance procedures for clinically urgently needed imported drugs and medical devices in accordance with regulations, and support electronic customs clearance of clinically urgently needed imported drugs and medical devices. Designated medical institutions and entrusted operating enterprises shall not import refurbished medical devices or transfer in-use medical devices from foreign medical institutions. It is prohibited to import expired, invalid, obsolete and used medical devices.

Clinically urgently needed imported drugs do not require import inspection. Medical devices and items listed in the "Special Items Customs Commodity Number and Inspection and Quarantine Name Correspondence Table" shall apply for administrative licenses in accordance with relevant customs regulations.

7. Approved clinically urgently needed imported drugs and medical devices are deemed to be varieties that have been approved for import registration in Lecheng Pilot Zone, and charitable donations are allowed, and they are managed as clinically urgently needed imported drugs and medical devices.

8. Designated medical institutions shall confirm the necessity of patients taking imported drugs and medical devices urgently needed for clinical use out of the Lecheng Pilot Zone according to the patient's condition and safety, formulate a plan for taking away and an emergency plan, and after filing on the licensed drug and medical device traceability management platform, patients can take imported drugs and medical devices urgently needed for clinical use out of the Lecheng Pilot Zone for use in reasonable quantities for their own use. The management measures for taking imported drugs and medical devices urgently needed for clinical use out of the Lecheng Pilot Zone shall be separately formulated by the Hainan Provincial Drug Supervision and Administration Department.

9. The Hainan Provincial Drug Supervision and Administration Department shall establish a licensed drug and medical device traceability management platform in conjunction with the Lecheng Pilot Zone Management Department to achieve full-process traceability management of application, procurement, import, distribution, use and adverse reaction monitoring of imported drugs and medical devices urgently needed for clinical use.

Designated medical institutions, entrusted operating enterprises, and Lecheng Pilot Zone bonded warehouses shall use the licensed drug and medical device traceability management platform to manage imported drugs and medical devices urgently needed for clinical use, and implement the main responsibility for full product traceability.

10. If the designated medical institution no longer has the ability and conditions to use clinically urgently needed imported drugs and medical devices, the Hainan Provincial Health and Health Administration will cancel the qualification of its relevant departments to use clinically urgently needed imported drugs and medical devices.

11. The designated medical institution shall conduct safety and effectiveness evaluation of the use of clinically urgently needed imported drugs and medical devices, and report to the Hainan Provincial Health and Health Administration and the Drug Supervision and Administration Department every year an evaluation report on the use of clinically urgently needed imported drugs and medical devices in the previous year.

12. After clinically urgently needed imported drugs and medical devices are approved for marketing in China, if there are unapproved indications, the product can be applied for use as clinically urgently needed imported drugs and medical devices, limited to unapproved indications.

13. Designated medical institutions are encouraged to introduce insurance mechanisms and purchase medical commercial insurance. If the use of clinically urgently needed imported drugs and medical devices causes human harm to patients, the designated medical institution shall bear responsibility in accordance with relevant national regulations. If the harm is caused by product reasons, the designated medical institution shall first compensate, and then seek compensation from the relevant responsible units according to law or agreement.