Shanghai Municipal Pilot Program for the Import of Biopharmaceutical Research and Development Items

(July 31, 2023)

SMCC D [2023] No. 3

This Program is formulated with a view to accelerating the process of establishing this Municipality as an influential hub for the biopharmaceutical industry in the world, and to advancing the pilot program for the import of biopharmaceutical R&D Items in an orderly manner.

I. General Requirements

According to the principle of "institutional and mechanism innovation, risk prevention, and convenience", a white list system shall be established for biopharmaceutical R&D items imported by biopharmaceutical enterprises (R&D institutions) (hereinafter referred to as the "white list"), to improve the information-based regulation and supervision, and achieve import facilitation, to the effect that "white list" goods imports shall go through with no need to handle the Drug Imports Customs Clearance Form.

II. Primary Tasks

1. Establishment of joint mechanisms at municipal and district levels for advancing the pilot program for the import of biopharmaceutical R&D items. Led by Shanghai Municipal Commission of Commerce, the joint mechanism at the municipal level for advancing the pilot program for the import of biopharmaceutical R&D items shall be established with the participation of Shanghai Customs, Shanghai Municipal Medical Products Administration, Shanghai Municipal Science and Technology Commission, Shanghai Science and Technology Innovation Office, and other departments, with its office located at the Municipal Commission of Commerce. Led by the competent departments of commerce, the joint mechanisms at the district level for advancing the pilot program for the import of biopharmaceutical R&D items shall be established with the participation of the departments of market regulation, and science and technology, with offices located at the district departments of commerce.

2. Recognition of the White List. The White List consists of two parts: enterprises (R&D institutions) and imported R&D items, with a one-to-one correspondence of the pilot enterprise (R&D institution) and its pilot imported R&D items.

Enterprises (R&D institutions) registered in this Municipality shall file an application for access to the White List to the joint advancement mechanism office of the district where they are registered. Enterprises (R&D institutions) registered in China (Shanghai) Pilot Free Trade Zone Lin-gang Special Area (hereinafter referred to as the "Lin-gang Special Area") shall file an application for access to the White List to the Lin-gang Special Area Administration. Recognized by the joint advancement mechanism at the municipal level, the White List shall be recommended to the joint advancement mechanism at the municipal level by the joint advancement mechanism at the district level or by the Lin-gang Special Area Administration, and be jointly promulgated by member units of the joint advancement mechanism at the municipal level including Shanghai Municipal Commission of Commerce, Shanghai Customs, Shanghai Municipal Medical Products Administration, Shanghai Municipal Science and Technology Commission, and Shanghai Science and Technology Innovation Office. Imports of items included in the White List may go through with no need to handle the Drug Imports Customs Clearance Form, while imports of items not included in the White List shall be subject to the current procedures.

The following requirements shall be met by enterprises (R&D institutions) and imported R&D items to be included in the White List:

(1) The business scale, R&D technologies, and project experience of enterprises (R&D institutions) shall match the pilot R&D business. Enterprises (R&D institutions) shall possess an information management system for full process traceability of related items, maintain favorable credit records, and have no significant instances of dishonesty or misconduct in the past three years.

(2) The types of items that may be imported by enterprises (R&D institutions) shall be determined based on their operational performances and in accordance with the principle of "enterprise-oriented, cutting-edge technology focus, and risk control".

(3) Enterprises (R&D institutions) shall establish and improve internal control systems, designate personnel in charge of the management of imported R&D items, establish ledgers for the use of imported R&D items, and undertake that the imported items shall be exclusively used for R&D, and that strict rules for management and disposal of these items shall be complied with during the usage process.

3. Pilot measures to facilitate customs clearance. An information platform shall be constructed to facilitate a quick check between the information on the White List and the declaration information provided by enterprises (R&D institutions). Enterprises (R&D institutions) included in the White List need not submit the Drug Imports Customs Clearance Form to go through customs clearance formalities.

4. Dynamic adjustment to the White List. The White List shall be dynamically adjusted in light of the process of the pilot program and the needs of enterprises (R&D institutions), and in principle shall be adjusted on a monthly basis.

5. Rapid recognition of biopharmaceutical items initiated by the "white list" enterprises (R&D institutions). When an enterprise (R&D institution) included in the White List applies again to the joint advancement mechanism office at the district level or the Lin-gang Special Area Administration for imported R&D items, it is not required to submit any additional declaration materials other than the information on those imported R&D items. The joint advancement mechanism at the district level or the Lin-gang Special Area Administration shall recommend enterprises (R&D institutions) to the joint advancement mechanism at the municipal level based on their applications. The joint advancement mechanism at the municipal level shall conduct real-time recognition outside of the monthly dynamic adjustment plan.

6. Clarification of liability for misconduct. Any pilot enterprise (R&D institution) confirmed to have committed any misconduct shall be disqualified for the pilot program and shall not be allowed to reapply within the pilot program period. Such information of misconduct shall be included in the enterprise credit record in accordance with the relevant provisions of this Municipality. If a case involves a criminal offense, such case shall be transferred to judicial authorities according to law.

III. Safeguard Measures

1. Coordinated promotion. Member units of the joint advancement mechanism at the municipal level shall strengthen their cooperation in promoting the pilot program to amplify the effect of the pilot program. The Municipal Commission of Commerce shall be responsible for the overall coordination of the pilot program. The Municipal Medical Products Administration shall be responsible for defining the attributes of biopharmaceutical R&D items. Shanghai Customs shall be responsible for the customs clearance of imported items, while the Municipal Science and Technology Commission and Shanghai Science and Technology Innovation Office shall be responsible for the coordination of the biopharmaceutical R&D business and the development throughout the biopharmaceutical industry chain.

2. Enhancement of organization and implementation. Member units of the joint advancement mechanisms at both municipal and district levels shall perform their respective duties in accordance with their statutory functions and duties, and strengthen supervision and regulation during and after the implementation process. Member units of the joint advancement mechanism at the district level shall strengthen the territorial administration, and report on a quarterly basis relevant inspection on the actual usage, subsequent disposal, and laboratory management of imported R&D items of the “white list” enterprises (R&D institutions) to the joint advancement mechanism at the municipal level. In case of any misconduct, such units shall promptly report to the corresponding municipal departments and the joint advancement mechanism office at the municipal level. The joint advancement mechanism at both municipal and district levels shall establish a regular meeting system to reinforce information exchange among all departments, promptly report the progress in the Pilot Program, and coordinate to address problems arising in the Pilot Program.

This Pilot Program shall be implemented as of August 1, 2023, and be effective till July 31, 2025.