The Implementation of FSMP Policies in the Hainan Boao Lecheng Pilot Zone

Establishment

The Hainan Boao Lecheng International Medical Tourism Pilot Zone (Lecheng Pilot Zone) was officially established on February 28, 2013, following approval by China's State Council. It was endowed with nine preferential policies aimed at international medical tourism industries such as licensed medical services, health management, care and rehabilitation, medical aesthetics, and anti-aging. It aims to gather high-end international and domestic medical tourism services and cutting-edge international medical technology, creating a hub for international medical technology services.

Policy support

On September 16, 2019, the National Development and Reform Commission (NDRC), National Health Commission (NHC), National Administration of Traditional Chinese Medicine (NATCM), and State Administration for Market Regulation (SAMR) jointly issued the Implementation Plan for the Development of the Boao Lecheng International Medical Tourism Pilot Zone. This plan proposed to allow the Lecheng Pilot Zone to import and use health products, healthcare equipment, and foods for special medical purposes (FSMP), that are marketed overseas but not domestically.

Initiative advancements

On September 16, 2021, the NHC, General Administration of Customs of the People’s Republic of China (GACC), and SAMR conducted a joint research visit to the Lecheng Pilot Zone. A symposium held during this visit reached preliminary consensus on implementing policies regarding FSMP. Leveraging experiences from licensed medical devices, the initiative will pilot FSMP targeting patients with rare diseases in urgent need. It will select established products and support early trials of FSMPs from system design, technical collaboration, and standard setting, aiming to explore reforms and innovations in China’s food safety evaluation and approval system.

On June 20, 2022, the Lecheng Pilot Zone Administration issued a Notice on Soliciting Overseas Marketed FSMPs for Early Trials, aiming to gather and access FSMPs that are available in international markets. The Expert Committee on Imported FSMPs reviewed and selected products that met the criteria for initial trials in an effort to accelerate the trial process.

In February 2023, Zhou Shiping, director of the special food safety supervision and management department, visited the Lecheng Pilot Zone and held discussions with related enterprises and the authorities of Lecheng.

On February 26-27, 2024, Liu Songtao, deputy director of the special food safety supervision and management department, along with relevant officials from the registration office, visited the Pilot Zone and held a workshop on the authorized import and use of FSMPs. During the meeting, preliminary consensus was reached on accelerating the implementation of relevant policies.

In February 2024, the SAMR released the key points for special food safety supervision in 2024. These include guiding the policy implementation in the Lecheng Pilot Zone, enhancing support for special food policies during events such as the Import Expo. Additionally, it emphasized expanding regional regulatory cooperation among provincial market supervision departments, in alignment with national strategic goals and risk management needs.

On May 11, 2024, the Constitution and Law Committee of the National People’s Congress visited the Lecheng Pilot Zone for research purposes. The meeting provided opinions and suggestions aimed at further advancing the implementation of policies related to the authorized import of special foods in Lecheng.

Policy implementation

On June 28, 2024, the 14th Session of the Standing Committee of the 14th National Peopl’s Congress approved a decision authorizing the State Council to temporarily adjust and trial provisions of the Food Safety Law of the People’s Republic of China in the Hainan Free Trade Port. This adjustment will be effective for a period of five years, starting from the date of this decision. The decision will come into effect on October 1, 2024.

Summary

Currently, the Lecheng Pilot Zone grants the following privileges for FSMPs: Following approval by the Hainan Provincial Government, it is allowed to temporarily import a limited quantity of legally marketed rare disease-specific FSMPs in urgent clinical trial needs and specific nutritionally complete foods. These products can be used within designated medical institutions located in the Lecheng Pilot Zone.

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