Beijing Establishes Ongoing Whitelist Scheme for Biopharmaceutical R&D Material Imports

On July 31, 2026, the Beijing Municipal Drug Administration, together with four other authorities including Beijing Customs, published the "Work Plan for the Import of Materials for Biopharmaceutical Research and Development in Beijing." The notice formally establishes a whitelist for biopharmaceutical R&D materials, addressing custom clearance challenges affecting certain materials used in biopharmaceutical R&D.

The move builds on Beijing’s whitelist pilot launched in 2022 and establishes and ongoing mechanism, providing a more predictable pathway for importing qualifying materials used in biopharmaceutical R&D. By institutionalizing the process, Beijing aims to facilitate R&D material imports and support innovation across the city’s biopharmaceutical sector, leveraging the China (Beijing) Pilot Free Trade Zone and the National Comprehensive Demonstration Zone for Expanding Opening-up of the Service Industry.

From Pilot Scheme to Ongoing Whitelist Mechanism

Certain materials used for biopharmaceutical R&D — including preclinical research materials, process materials and excipients that have not been marketed domestically or internationally in accordance with drug approval requirements — may fall under commodity codes included in the Imported Drug Catalogue.

However, where these materials do not fall within the circumstances covered by the Drug Import Administration Measures, an Imported Drug Clearance Form cannot be obtained. This can create a customs clearance barrier because the relevant commodity code would otherwise require the form for import clearance.

To address this issue, the five participating authorities established a joint mechanism coordinated through an office within the Beijing Municipal Drug Administration. This inter-agency group evaluates and publishes an official whitelist linking specific applicant entities with approved import items.

For applicants and materials included on the whitelist, imports can be cleared through Beijing Customs without the applicant first obtaining an Imported Drug Clearance Form, provided the customs declaration is made within the whitelist's validity period.

Criteria for Qualified Applicants and Import Materials

The regulatory framework applies strict eligibility boundaries to ensure that import facilitation does not compromise public safety or material control.

Eligible applicants must:

• Be registered biopharmaceutical enterprises or research institutions located in Beijing
• Have R&D facilities appropriate to the relevant research activities
• Maintain robust material tracking and risk-control systems
• Have no illegal, regulatory, or serious dishonest records during the two years preceding the application

For overseas pharmaceutical and biotech companies working with Beijing-based research organizations, the whitelist applicant must be a biopharmaceutical enterprise or R&D institution registered in Beijing and must be the actual consignee or consuming/using entity stated on the customs declaration.

Whitelisted materials are limited to the applicant’s own R&D activities within Beijing and may not be used for clinical trials, commercial distribution, sales, gifts, or other purposes outside the approved R&D use.

Eligible Materials

The whitelist covers materials used as preclinical research materials, process materials or excipients that have not been marketed domestically or internationally in accordance with drug approval requirements and that cannot obtain an Imported Drug Clearance Form despite falling under commodity codes included in the Imported Drug Catalogue.

Materials prohibited or restricted from import by the state, as well as narcotic drugs, psychotropic substances, radioactive products and precursor chemicals, are excluded.

Materials falling within the circumstances governed by the Drug Import Administration Measures, as well as materials eligible for one-time import processing, must continue to complete the applicable import registration or filing procedures in accordance with the law.

How the Whitelist Works

Applications are submitted to the Office of the Joint Promotion Mechanism within the Beijing Municipal Drug Administration and are assigned for two designated reviews, each of which must be completed within 10 working days of receiving the relevant identification task:

Following the required identification, the Office of the Joint Promotion Mechanism consolidates the results. The five participating departments then jointly determine and publish qualifying applicants and imported items, with the whitelist dynamically adjusted as applications are processed.

Validity and Repeat Applications

• Whitelist validity: Whitelist entry is valid for 12 months from the date of publication. Applicants must complete customs clearance within this validity period and must reapply after expiry.
• Existing pilot whitelist entries: Whitelist items published under the 2022 pilot scheme remain valid until December 31, 2026.
• Repeat applications: Where the same applicant imports the same item again for the same R&D purpose and the attributes of the imported item remain consistent with the previous application, the member departments are exempt from repeating the identification process and the item can be jointly published directly following submission of the import application.

Post-Import Compliance Remains Critical

The streamlined customs process does not remove ongoing regulatory obligations. Applicants must maintain full-process traceability for whitelisted materials and establish records covering their procurement, storage, use, and disposal.

Tracking and Disposal

Organizations must maintain records covering procurement, storage, internal requisitions, and final consumption.

After completion of the R&D project, applicants must render any unused whitelist materials harmless and submit a report on their use and harmless disposal to the Office of the Joint Promotion Mechanism within one month of completing the R&D project.

Record Retention and Non-Compliance Consequences

Original management records reflecting the actual flow of imported materials, including ledgers and harmless-treatment records, must be retained for at least five years from the end of the R&D project. Where laws, regulations or rules require a longer retention period, those requirements apply.

The Beijing Municipal Bureau of Commerce will take the lead in regularly organising relevant municipal and district departments to inspect the use of whitelist materials.

Entities that breach the rules or divert research materials may:

• Be removed from the whitelist immediately
• Be barred from re-applying for two years
• Face credit penalties
• Be referred for criminal investigation where applicable

What the Whitelist Means for International Life Science Companies

For qualifying applicants and materials included on the whitelist, the pathway removes the need to obtain an Imported Drug Clearance Form and can therefore reduce customs-related friction for biopharmaceutical R&D activities in Beijing.

The simplified clearance pathway does not remove post-import responsibilities. Applicants remain responsible for the scientific, reasonable, and safe use of imported materials, full-process traceability, risk prevention and control, and compliant disposal. For international companies working through Beijing-based R&D partners, these responsibilities should be clearly defined between the parties.

International companies should therefore first determine whether the relevant material and their Beijing-based R&D entity meet the whitelist eligibility criteria before relying on this import pathway.

Cisema supports international life science companies in assessing China import requirements, coordinating regulatory submissions, and establishing compliant pathways for biopharmaceutical R&D activities.

Contact Cisema to explore our China pharmaceutical consulting services and build a compliant pathway for your R&D operations.

Further Information

• Explore Cisema’s pharmaceutical consulting services.

References

• Notice from the Beijing Municipal Medical Products Administration, Beijing Municipal Science and Technology Commission, Zhongguancun Science Park Administrative Committee, Beijing Municipal Bureau of Economy and Information Technology, Beijing Municipal Bureau of Commerce, and Beijing Customs on Issuing the "Beijing Biopharmaceutical R&D Materials Import Work Plan."
• Explanation of the "Beijing Municipality Work Plan for the Import of Items for Biomedical R&D"