Recently, the Hainan Provincial Food and Drug Administration, Health Commission of Hainan Province and Haikou Customs jointly issued a notice on the Several Measures to Further Optimize Regulatory Services to Support the High-Quality Development of Hainan Boao Lecheng International Medical Tourism Pilot Zone (hereinafter referred to as Several Measures). 

Several Measures is intended to further optimize the business environment in Lecheng, simplify the approval process of imported medicines and medical devices in urgent clinical need, optimize the approval mode, improve the effectiveness of regulatory services, facilitate the public to timely use imported medicines and medical devices in urgent clinical need, and help the high-quality development of Lecheng.

To further optimize the business environment in Lecheng, simplify the approval process of imported drugs and medical devices in urgent clinical need, optimize the approval mode, improve the effectiveness of regulatory services, facilitate the public to timely use imported medicines and medical devices in urgent clinical need, and help the high-quality development of Lecheng after research, the following measures are developed:

I. The health administration departments of Hainan province are responsible for the qualification assessment and review of medical institutions that apply for the use of imported medicines and medical devices in urgent clinical need, and support medical institutions to apply for assessment in accordance with their own departmental capacity by department. Medical institutions that intend to engage in the business of using imported medicines and medical devices in urgent clinical need should apply to the health administration departments of Hainan province, and have the following conditions:

(I). Obtain a license to practice at a medical institution in accordance with the law with a professional department (including telemedicine medical team) appropriate to the imported medicines and medical devices in urgent clinical need applied for;

(II). Have developed guaranteed conditions and management systems in their circulation, transportation, storage and custody if it meets the requirements of characteristics and instructions of the imported drugs and medical devices in urgent clinical need;

(III). Set up medicine and medical device adverse reaction monitoring institutions equipped with full-time personnel who have received professional training to be able to properly perform the monitoring of adverse reactions;

(IV). If serious adverse reactions may occur due to the use of imported medicines and medical devices in urgent clinical need, the ability to develop emergency plans and disposal is required.

After receiving the application, the health administration departments of Hainan province shall make a decision within 10 working days whether to allow the relevant departments of medical institutions to use the imported medicines and medical devices in urgent clinical need. Medical institutions qualified to use imported medicines and medical devices in urgent clinical need are called designated medical institutions.

II. Designated medical institutions should, according to the target indications, specify the type and quantity of imported medicines and medical devices in urgent clinical need to be applied for use, submit applications online in the licensed medicines and devices traceability management platform in accordance with the declaration requirements, and undertake that the application information is legal, true, accurate and traceable, and that the imported medicines and medical devices in urgent clinical need are used in the medical institution. Declaration guidelines are developed separately. 

III. The health administration department and drug administration of Hainan province shall, in accordance with their duties, evaluate and review the imported medicines and medical devices in urgent clinical need that are applied for use by designated medical institutions.

After receiving the application from designated medical institutions to use the imported medicines and medical devices in urgent clinical need, the health administration departments of Hainan province shall complete the review within three working days, and the drug administration of Hainan province shall make an administrative decision within seven working days whether to grant the import.

After the imported medicines and medical devices in urgent clinical need are approved for the first time for use in Lecheng, all subsequent applications are considered non-first time, and the approval is implemented by Lecheng pharmaceutical regulatory department.

IV. For imported medicines and medical devices in urgent clinical need with inconsistent management properties inside and outside the country, it is managed according to the properties approved outside the country. 

V. Designated medical institutions should entrust pharmaceutical or medical device enterprises to purchase, import and distribute the imported medicines and medical devices in urgent clinical need.

Entrusted pharmaceutical or medical device enterprises (hereinafter referred to as entrusted enterprises) shall hold a "medicine business license" or "medical device business license".

VI. The Hainan Provincial Food and Drug Administration and Haikou Customs shall handle clearance procedures for imported medicines and medical devices in urgent clinical need in accordance with the provisions and support electronic customs clearance of imported medicines and medical devices in urgent clinical need. Designated medical institutions and entrusted enterprises shall not import refurbished medical devices or transfer medical devices in use from foreign medical institutions. It is forbidden to import expired, invalid, obsolete and used medical devices.

Imported medicines in urgent clinical need are not subject to import inspection. Medical devices and items included in the Correspondence Table of Customs Commodity Codes and Inspection and Quarantine Names for Special Items shall be subject to administrative licensing in accordance with relevant customs regulations. 

VII. The imported medicines and medical devices in urgent clinical need approved for use are treated as a variety that has been approved for import registration in Lecheng and is allowed to receive charitable donations and are managed according to the imported medicines and medical devices in urgent clinical need.

VIII. Designated medical institutions shall, according to the patient's condition and safety, confirm the necessity of the patient to use imported drugs and medical devices in urgent clinical need out of Lecheng, develop a take-away plan and an emergency plan, and after filing on the licensed medicines and devices traceability management platform, the patient may take a reasonable amount of imported medicines and medical devices in urgent clinical need out of Lecheng only for his or her own use. The management method of taking imported medicines and medical devices in urgent clinical need out of Lecheng for use shall be separately developed by the Hainan Provincial Food and Drug Administration.

IX. The Hainan Provincial Food and Drug Administration in conjunction with Lecheng management department to establish a licensed medicines and devices traceability management platform to achieve the application, procurement, import, distribution, use, adverse reaction monitoring and other whole-process traceability management of the imported medicines and medical devices in urgent clinical need.

Designated medical institutions, entrusted enterprises and Lecheng bonded warehouses should use the licensed medicines and devices traceability management platform for the management of imported drugs and medical devices in urgent clinical need, and the implementation of the main responsibility of whole-process traceability of the product.

X. For designated medical institutions that no longer have the ability and conditions to use imported medicines and medical devices in urgent clinical need, the health administration department and drug administration of Hainan province shall disqualify its relevant departments to use imported medicines and medical devices in urgent clinical need.

XI. Designated medical institutions shall carry out the safety and effectiveness evaluation of the use of imported medicines and medical devices in urgent clinical need, and report annually to the health administration department and drug administration of Hainan province on the evaluation report of the use of imported medicines and medical devices in urgent clinical need from the previous year.

XII. After the imported medicines and medical devices in urgent clinical need are approved for marketing in China, if there are unapproved indications, the product can be applied for use as imported medicines and medical devices in urgent clinical need only for unapproved indications.

XIII. Designated medical institutions are encouraged to introduce insurance mechanisms and purchase medical commercial insurance. If the use of imported medicines and medical devices in urgent clinical need causes human injury to the patient, the designated medical institution shall assume the responsibility in accordance with the relevant State regulations. If the injury is caused by the product, the designated medical institution shall pay compensation, and then recover from the relevant responsible unit according to the law or agreement.