Notice on Issuing the Pilot Work Plan of Guangzhou Development District and Huangpu District for the “White List” of Imported Items for Biopharmaceutical Research and Development

Sui Pu Shi Jian Gui Zi [2024] No.1

Market Regulation Administration of Huangpu District of Guangzhou City, Investment Promotion Bureau of Guangzhou Development District, Science and Technology Bureau of Huangpu District of Guangzhou City, Industry and IT Bureau of Huangpu District of Guangzhou City, Commerce Bureau of Guangzhou Development District, Bureau of Business Environment Reform of Guangzhou Development District, Suidong Customs

Notice on Issuing the Pilot Work Plan of Guangzhou Development District and Huangpu District for the “White List” of Imported Items for Biopharmaceutical Research and Development

To all relevant organizations in Guangzhou Development District (Huangpu District):

The “Pilot Work Plan of Guangzhou Development District and Huangpu District for the “White List” of Imported Items for Biopharmaceutical Research and Development”, which has been approved by the Guangzhou Development District Administrative Committee and the People’s Government of Huangpu District, is hereby issued for implementation. Please contact the District Market Regulation Administration if you encounter any problem while implementing the Pilot Work Plan.

Market Regulation Administration of Huangpu District of Guangzhou City, Investment Promotion Bureau of Guangzhou Development District

Science and Technology Bureau of Huangpu District of Guangzhou City, Industry and IT Bureau of Huangpu District of Guangzhou City

Commerce Bureau of Guangzhou Development District, Bureau of Business Environment Reform of Guangzhou Development District

Suidong Customs

July 10, 2024

Pilot Work Plan of Guangzhou Development District and Huangpu District for the “White List” of Imported Items for Biopharmaceutical Research and Development

This Pilot Work Plan is formulated to implement the arrangements for creating a “white list” of items needed for biopharmaceutical R&D, as stated in the “Notice of the General Office of Guangzhou Municipal People’s Government on Several Policy Measures Aimed to Promote the High-quality Development of the Biopharmaceutical Industry” (Sui Fu Ban Gui [2024] No.1). It is also intended to give full play to the pioneering role of the Development District and Huangpu District in developing the biopharmaceutical industry in the Guangdong-Hong Kong-Macao Greater Bay Area (GBA), advance the pilot import of items for biopharmaceutical R&D in a well-planned manner, and raise the R&D efficiency and capability of biopharmaceutical companies, with a view to creating a world-class biopharmaceutical innovation hub.

I. General requirements

Based on the biopharmaceutical industrial cluster comprising “three cities and one island” in the Development District and Huangpu District, the “white list” of imported items for biopharmaceutical R&D in relevant companies and R&D institutes is formulated on the principle of “innovative services, coordinated risk control, and efficiency and convenience”. As no Customs Clearance for Imported Medicine needs to be obtained or provided for the items on the white list, the system would improve IT-based supervision and facilitate import customs clearance.

II. Scope of the pilot program

The white list consists of two parts – companies (R&D institutes) and items. Each pilot company (R&D institution) corresponds to specific imported items.

The pilot companies (R&D institutes) are those that are legally registered and are engaged in production, operation, and scientific research activities in Guangzhou Development District and Huangpu District. They should: (1) have the business scale and R&D capability matching the pilot R&D work; be responsible for the science-based, rational, and safe use of the imported items in the R&D process; and be able to trace the used items throughout the process; (2) have a sound credit record with no major breaches or violations of law or regulations in the past two years, and are not listed as bad-faith entities by the Customs; (3) establish and improve their internal control system; designate personnel to be specifically responsible for the import of the items needed for R&D; create accounts of the imported items; promise that all the imported items will be used for R&D purposes only and not for clinical, sales, or other purposes; and manage and handle the items in strict accordance with relevant norms and standards.

The pilot items should meet the following conditions. (1) They have to be imported for the R&D of biopharmaceutical products by relevant companies, but a Customs Clearance for Imported Medicine has to be provided for their import because they are included in the “Catalogue of Imported Medicine”; (2) At the moment, they do not include medical apparatus or other items whose import is prohibited or restricted by China. The import of items not on the “white list” follows existing regulations. The imported items should enter the country at state-designated ports for medicines.

III. Main tasks

(I) Forming a joint workforce to promote the pilot import of items needed for biopharmaceutical R&D

A joint taskforce led by the Huangpu District Market Regulation Administration and comprising personnel from the Investment Promotion Bureau of Guangzhou Development District, Science and Technology Bureau of Huangpu District, Industry and IT Bureau of Huangpu District, Commerce Bureau of Guangzhou Development District, Bureau of Business Environment Reform of Guangzhou Development District, and Suidong Customs will be formed to promote the pilot import of items needed for biopharmaceutical R&D. The office of the joint taskforce will be set in Huangpu District Market Regulation Administration.

(II) Formulation of the “white list”

1. During the term of the pilot program, the joint taskforce will accept applications once half a year. Eligible companies (R&D institutes) should, within the specified period, apply to the joint taskforce for inclusion in the “white list” according to the prescribed requirements on relevant materials and procedures.

2. The Science and Technology Bureau of Huangpu District will be responsible for reviewing the R&D conditions of the biopharmaceutical companies (R&D institutes), with assistance from the Industry and IT Bureau of Huangpu District, Commerce Bureau of Guangzhou Development District, Bureau of Business Environment Reform of Guangzhou Development District, and Suidong Customs when it comes to key enterprises. Experts can be invited to join the review if necessary.

3. The Huangpu District Market Regulation Administration, in conjunction with Suidong Customs, is responsible for reviewing the quantity and properties of the items submitted by eligible biopharmaceutical companies (R&D institutes). Experts can be invited to join the review if necessary.

4. The “white list” enumerating the approved biopharmaceutical companies (R&D institutes) and their corresponding imported items should be countersigned by the members of the joint taskforce.

(III) Release of the “white list”

The joint taskforce will announce the approved “white list” in the “Government Affairs” section of the government website. The list will be dynamically updated according to the progress on the pilot program and the needs of the pilot companies (R&D institutes), every half year on principle.

(IV) Validity of application

Within six months after the “white list” is announced, the concerned companies (R&D institutes) should complete the Customs formalities for their listed items and submit relevant materials to the join taskforce. The application would become invalid beyond this period, and the companies (R&D institutes) may apply again as needed.

(V) Facilitated Customs Clearance 

No Customs Clearance for Imported Medicine needs to be obtained or provided for the import of items on the white list. The Suidong Customs will not check the Customs Clearance for Imported Medicine for items on the white list. The import of items not on the list should follow the existing regulations.

(VI) In-process and ex-post regulation 

The office of the joint taskforce will regularly organize joint inspections of how the “white list” items are used to realize close-loop management. They will focus on whether the actual purchase, use and inventory of the items consist with the records, whether the items are used only for the R&D purposes stated on the application, and whether the used quantities are rational. This is to make sure the “white list” items are traceable during the full process and put under close-loop control without any risk of unauthorized use.

Any violation identified will disqualify the concerned company or R&D institute from the pilot program. The said company or R&D institute shall not make another application within two years, and the violation will be put on its credit record as per relevant regulations. If any company uses the imported “white list” items for clinical, sale or productive purposes, it will be subject to punishment by the Huangpu District Market Regulation Administration as per relevant laws and regulations; if the circumstances constitute crimes, the company will be held criminally accountable.

IV. Safeguards

(I) Strengthened coordination 

The joint taskforce will form a joint meeting system and hold regular meetings to coordinate and advance the assessment on the pilot “white list” program, so as to communicate information, report progress, and solve problems in a coordinated way.

During the implementation of the pilot program, when major decisions or arrangements have to be discussed and decided, the joint taskforce will convene a joint meeting involving all the members. The members should report their work summary to the joint taskforce every half year, and the joint taskforce will produce an evaluation report and distribute it to all members.

(II) Strengthened accountability of relevant companies 

The companies (R&D institutes) must carry out their R&D work in strict accordance with the purposes stated in their applications. They are also responsible for preventing, controlling, and handling risks concerning the quality, safety, use, and management of the imported items to prevent any malpractice. When the R&D is completed, they should report the use of the imported items to the joint taskforce in a timely manner, and dispose of the unused “white list” items as per the requirements made by the eco-environmental authority and the Market Regulation Administration.

(III) Strengthened government services

The joint taskforce will promote the “white list” system in a larger scope and guide its implementation. Following the fundamental principle of “tolerance and correction of mistakes” for reform and innovation in the district, greater efforts will be made to follow up on and study the problems that may occur during the pilot program and timely analysis will be made to further refine the “white list” system.

V. Duration

This pilot work plan will be in force for two years from the day of issuance.

Attachment: Materials and procedures required to apply for inclusion in the “white list”

Attachment 

Materials and procedures Required to Apply for Inclusion in the “White List”

I. Application materials 

1. Application form (attached)

2. Copy of legal registration certificate of the applicant company (R&D institute)

3. Application report, including the source, purpose of use, quantities, and plan of use of the items to be imported; and the R&D conditions of the applicant company (R&D institute), its management of item use, and risk prevention and control measures.

4. Letter of commitment (attached). The applicant company (R&D institute) shall make a written commitment that they will not use the imported items for clinical, sale or other purposes not listed on the application.

5. Foreign license of the items to be imported (if applicable).

6. Copy of the purchase contract of the items.

7. Other materials deemed necessary.

II. Procedures 

1. Companies (R&D institutes) eligible for the pilot program should submit, in written form, the application materials required as above to the office of the joint taskforce prior to the designated date (to be notified later). The office of the joint taskforce is located at Room 711, Building A1, No.239 on the Kexue Avenue, Huangpu District (tel: 020-82026131).

2. The joint taskforce should review the applicant companies (R&D institutes) and their corresponding items within 20 workdays. The approved applicants and corresponding items will be announced to the public every half year and dynamically updated, while a written notification will be provided to those not approved.

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