How to promote the development of the biomedical industry in the pilot free trade zone?

Since the establishment of the China (Shanghai) Pilot Free Trade Zone in 2013, my country has successively approved the establishment of 21 free trade zones, which has basically formed a situation of comprehensive advancement from the coast to the inland, covering the east, west, south and north.

All free trade zones have a supportive attitude towards the biomedical industry, making full use of the advantages of "first move, first trial" to explore new paths and new models for upgrading the biomedical industry.

01

Promote the import and retail of pharmaceutical equipment

1.

In 2019, the Food and Drug Administration issued a notice on the evaluation criteria for the first drug import port, and the application for adding the first drug (excluding medicinal materials) import port should match the demand, focusing on the establishment of free trade zones in the region or the establishment of biomedical industrial parks by local governments .

In the same year, the Chongqing Pilot Free Trade Zone was approved to establish a port for the first import of drugs and biological products, becoming the fourth designated customs clearance port after Beijing, Shanghai and Guangzhou; Jiangsu Free Trade Zone, Hainan Free Trade Zone, Anhui Free Trade Zone, etc.

2.

The Beijing Free Trade Zone proposed to launch a pilot project for cross-border e-commerce retail imports of drugs.

02

The application of advanced technologies such as stem cells and gene therapy takes the lead

my country's regulatory system in the field of cell and gene therapy is imperfect, and there are relatively large restrictions on foreign investment.

03

Drugs and devices review, approve, and test first

1.

Tianjin Free Trade Zone, Shanghai and other places strive to apply for the import of a small amount of medicines (excluding vaccines) from medical institutions in the free trade pilot zone due to urgent clinical needs, and the Municipal People’s Government shall implement the examination and approval; the approved imported medicines shall be in designated medical institutions Used internally for specific medical purposes.

In addition, the Hainan Boao Lecheng International Medical Tourism Pilot Zone has introduced a new policy to allow patients to take licensed new drugs out of the park.

2.

In the Jiangsu Free Trade Zone, anti-cancer drugs, rare-disease drugs and other clinically urgently needed innovative drugs will be given priority review and approval; the quarantine and inspection process of special items for biomedical global collaborative research and development will be optimized.

3.

The Tianjin Free Trade Zone and the Guangdong Free Trade Zone implemented trial filing management of imported non-special use cosmetics, and the management authority was delegated to Tianjin City/Guangdong Province.

04

Cross-border data policy first trial

1.

The State Food and Drug Administration has organized and formulated the "Technical Guidelines for the Use of Real-World Data in the Clinical Evaluation of Medical Devices (Trial)" to standardize and guide the application of real-world data in the clinical evaluation of medical devices.

The Hainan Free Trade Port Boao Lecheng International Medical Tourism Pilot Zone encourages the development of clinical real-world data application research in the pilot zone, and explores the use of clinical real-world data for drug and medical device product registration to shorten the time to market.

On March 26, 2020, the National Medical Products Administration approved the registration of the "Glaucoma Drainage Tube" product from Allergan of the United States after review.
The product was used in the Hainan Free Trade Port Boao Lecheng International Medical Tourism Pilot Zone The collected clinical real-world evidence is used to evaluate ethnic differences.
It is the first medical device product approved in China that uses real-world evidence to assist clinical evaluation.

2.
Improve the security of cross-border data flow

The Lingang New Area of ​​the Shanghai Free Trade Zone focuses on key areas such as integrated circuits, artificial intelligence, biomedicine, and headquarters economy, and pilots the security assessment of cross-border data flows, and establishes data protection capability certification, data circulation backup review, and cross-border data circulation.
Data security management mechanisms such as transaction risk assessment.

05

Leading the way for major policies

The free trade zone is a pilot field for the first trial of major policies related to biomedicine.
Based on the pilot work of the medical device registrant system carried out in the Shanghai, Guangdong, and Tianjin Free Trade Zones in the early stage, the National Medical Products Administration issued the "Notice on Expanding the Pilot Work of the Medical Device Registrant System" to further expand the pilot program of the medical device registrant system To 21 provinces, autonomous regions, and municipalities directly under the Central Government, such as Beijing and Tianjin, further realize the "relaxation" of product registration and production licenses, making it easier for innovative results to come out.