A few days ago, the Guangdong Provincial Government issued the “Several Measures on Promoting the Reform and Innovation of Trade and Investment Facilitation in the Guangdong Pilot Free Trade Zone” (hereinafter referred to as “Several Measures”). The document proposes to improve the convenience of importing pharmaceutical products.
The Provincial Department of Commerce explained that the “Several Measures” proposed a total of 27 specific measures in 15 areas, including investment opening, trade facilitation, shipping and logistics, and financial innovation.
In terms of improving trade convenience and promoting the development of new trade formats, the “Several Measures” proposes measures to promote imports, such as cultivating import trade promotion innovation demonstration zones, creating import goods distribution centers, and innovating trade supervision models. And, carry out pilot projects to facilitate the import of biomedical research and development items, and cross-border e-commerce retail import of some drugs and medical devices to improve the convenience of importing pharmaceutical products.
Guangdong will carry out a pilot project to facilitate the import of biomedical research and development items, establish a “white list” system for biomedical enterprises (R&D institutions) to import research and development items, and simplify the procedures for importing “white list” items to go through the “Import Drug Clearance Form”.
The “Several Measures” proposes to make good use of the relevant policies for the management of drugs and medical devices imported from Hong Kong and Macau that are urgently needed for clinical use in the Guangdong-Hong Kong-Macao Greater Bay Area, and encourage the entry and exit of related drugs and medical devices through the Guangdong Pilot Free Trade Zone. Support the Qianhai Shekou Area to apply for the establishment of a port for the first import of drugs and biological products.
According to the “Drug Administration Law”, drugs marketed in China must be approved by the drug regulatory department of the State Council to obtain a drug registration certificate. This process takes a long time, and many patients seek medical treatment across borders.
At present, the policy of “Hong Kong and Macao Medicine and Machinery” is being extended to 9 cities in the Pearl River Delta, and the first batch of 5 designated medical institutions involve Guangzhou, Shenzhen, Zhuhai, Zhongshan and other cities. The “Hong Kong-Macao Drug-Machine Link” aims to connect with the relevant regulatory mechanisms of Guangdong, Hong Kong and Macau, and open up a new entry channel for drugs and devices that are urgently needed in clinical practice and have been marketed in Hong Kong and Macau.
For example, the University of Hong Kong-Shenzhen Hospital, as the first pilot medical institution, introduced new tumor drugs “entrectinib” and “lorlatinib” to provide alternative treatments for patients with refractory and specific gene mutation cancer types. None of the drugs are listed in the mainland. (For details, please refer to Nandu’s previous report that Guangdong will implement the “Policy on the Use of Hong Kong and Macau Drugs in the Greater Bay Area” in stages.)
The Guangdong Provincial Drug Administration has now accepted applications for the import and use of medical devices and drugs urgently needed from Hong Kong and Macao. In order to standardize the work of imported medicines and medical devices urgently needed for clinical practice in the Guangdong-Hong Kong-Macao Greater Bay Area, since March 1, the approval documents for imported medicines and devices urgently needed for clinical applications in the Guangdong-Hong Kong-Macao Greater Bay Area have been officially launched.
In September 2021, the “Several Measures on Promoting Trade and Investment Facilitation Reform and Innovation in Pilot Free Trade Zones” issued by the State Council proposed that qualified pilot free trade zones should be allowed to carry out cross-border e-commerce retail and import of some drugs and medical devices. Eligible pilot free trade zones will add ports for the first import of drugs and biological products.
Earlier in May, Henan Province was approved to take the lead in launching a pilot program of cross-border e-commerce retail imports of drugs. According to official information, 13 over-the-counter drugs (including 9 drugs such as Huoluo Oil are produced in Hong Kong) that have obtained marketing authorization in China have been included in the pilot varieties, and the customs clearance form of imported drugs will not be checked during the customs clearance; , the tariff rate is temporarily set to 0%, and the import value-added tax and consumption tax have been cancelled and exempted, and temporarily levied at 70% of the statutory tax payable.
Guangdong will strive to carry out a pilot program of cross-border e-commerce retail imports of some drugs and medical devices. According to the “Several Measures”, support the development of cross-border e-commerce retail import of some drugs and medical devices in the Guangdong Pilot Free Trade Zone, and establish cross-border e-commerce retail imports of some drugs and medical devices. Quality supervision, full-chain traceability, consumer rights and interests guarantee mechanisms.
In addition, the Guangdong-Hong Kong-Macao Greater Bay Area “Combined Port” will explore to expand the scope of application, and the policy will support the Nansha and Qianhai Shekou areas to further innovate the customs clearance supervision method, optimize the business process, and improve the level of regional customs clearance facilitation.
The “Several Measures” also proposes related measures to improve the efficiency of land resource allocation. Among them, priority should be given to ensuring the reasonable land use needs of the Pilot Free Trade Zone, and the supply of “standard land”, “with projects” and “with plans” for key links in the industrial chain and industrial land for core projects.
Attachment: A picture to understand several measures to promote the reform and innovation of trade and investment facilitation in the Guangdong Pilot Free Trade Zone
From the official website of the Guangdong Provincial Government
Written by: Southern Metropolis reporter Huang ShulunReturn to Sohu, see more
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