Wang Yifei, Qiao Pian
In order to respond to the innovation demands of enterprises and further improve the facilitation level of import customs clearance for imported biopharmaceutical R&D items, for items used as preclinical research and process materials (excipients) in the process of biopharmaceutical research and development, or medical devices and parts (non-diagnostic reagents) for research and development that have been marketed abroad but not registered in China, a "whitelist" method is adopted to determine the importing units and their imported items, so that the "whitelist" items can be cleared without submitting the Customs Clearance Form for Imported Drugs.
What is the "whitelist" system?
The customs and other relevant departments have established a joint promotion mechanism. Based on the principles of "innovative mechanisms, optimized services, convenient customs clearance, and controllable risks", each department adopts a "whitelist" method to determine the list of imported biopharmaceutical R&D items by enterprises, universities and institutes. The units and items should correspond one by one, so that the "whitelist" items can be cleared without submitting the Customs Clearance Form for Imported Drugs.
Scope of "whitelist" pilot items
The scope of pilot items includes items used as preclinical research and process materials or excipients in the process of biopharmaceutical research and development by enterprises, universities and institutes; medical devices and parts (non-diagnostic reagents) for research and development that have been marketed abroad but not registered in China. For example, the "whitelist" for imported R&D items by the first batch of biopharmaceutical companies released by Hubei Province include 5 items such as other antibiotics (cyclosporin A) and other antibiotics (cardiamycin hydrochloride) that a company is allowed to import.
Identification procedure of "whitelist"
A joint promotion mechanism office is established to coordinate the identification, release, supervision and implementation of the "whitelist".
1. Enterprises, universities and institutes apply to the joint promotion mechanism office for inclusion in the "whitelist". Based on the principle of "service innovation, focusing on the frontier, and controllable risks", they propose the types, specifications, and import volumes of imported items, and explain the necessity of the imported items.
2. The departments jointly evaluate and identify the imported items, jointly issue a document after confirming the "whitelist", and dynamically adjust the "whitelist" as needed. Items that fall under the provisions of the Administrative Measures for the Import of Drugs and can be processed for the Customs Clearance Form for Imported Drugs are not included in the "whitelist".
3. Conditions that the "whitelist" pilot units should have.
(1) The pilot units should have the R&D capabilities that match the pilot and the ability to trace the entire process of the used items. They should have good credit records and no serious dishonesty.
(2) The pilot units should implement their main responsibilities, establish and improve internal control systems and imported items use ledgers, designate special personnel to be responsible for the import management of R&D items, and promise that imported items are only used for R&D purposes and shall not be sold, donated, exchanged or otherwise changed in the ownership and use of biopharmaceutical R&D items.
(3) The pilot units shall be responsible for the scientific, reasonable and safe use of imported items during the research and development process, undertake quality safety, use management, risk prevention and control and treatment during the process, and strictly manage and destroy them in accordance with the specifications during use.
Handling procedures
1. The relevant units submit a "whitelist" application to the joint promotion mechanism office. The application materials include:
(1) Application form.
(2) Letter of commitment.
(3) Application report (basic information of the unit, including scientific and technological innovation, customs credit management category, etc.; necessity of the items to be applied for import, including R&D needs, source of items, specific uses, quantity, use plan, etc.; internal control management system, including use management, traceability, risk prevention and control measures, etc.)
(4) A copy of the unit registration certificate and other materials that are considered necessary to be submitted.
2. The joint promotion mechanism office organizes member units to conduct evaluation and identification.
3. It proposes the identification results after research (if the conditions and materials do not meet the requirements, the applicant will be informed).
4. It makes an announcement.
5. The customs handle the facilitation customs clearance procedures in accordance with regulations.
The joint promotion mechanism office takes the lead and regularly organizes relevant departments to conduct inspections on the use of "whitelist" items. If violations are found, the unit's pilot qualification will be revoked. It will strengthen credit supervision, improve regulatory efficiency, and include illegal and irregular information in scientific research integrity records in accordance with relevant regulations. Those involved in criminal offenses shall bear the corresponding legal responsibilities.
Disclaimer：The above content is translated from Chinese version of China Inspection and Quarantine Times. The China Inspection and Quarantine Times version shall prevail.
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