I. Policy Innovation

A whitelist system has been established for the import of R&D items by biomedical enterprises/or research institutions in Beijing. For those items whitelisted, companies are not required to submit the Drug Import Customs Clearance form when going through customs procedures with Beijing Customs.

II. Policy Basis

Administrative Measures for the Import of Drugs (No. 4, issued by the former State Food and Drug Administration, currently the National Medical Products Administration); Plan for Beijing’s Pilot Program for Import of Biomedical R&D Items (No. 166 [2022], issued by Beijing Municipal Medical Products Administration)

III. Scope of Application

This program is applicable to biomedical enterprises (or research institutions) registered in the following areas: Haidian District, Changping District, Daxing District, and Beijing Economic-Technological Development Area.

Enterprises outside the pilot areas may apply through their local science and technology authorities. Upon evaluation by the joint implementation mechanism, they may be included in the pilot program.

The pilot covers items used by biomedical enterprises (or research institutions) in the R&D process, including those used for preclinical research, process materials, or excipients. These items fall under the Imported Drug Catalog due to their commodity codes, resulting in customs clearance difficulties due to regulatory condition coded Q.

IV. Application Requirements

Applicants must meet all the following criteria:

1. The enterprise must be registered within the pilot area;

2. The item must fall within the pilot item scope;

3. A one-to-one correspondence between enterprise and item must be maintained. The item must be for the enterprise's own use, and the enterprise must be capable of full-process traceability of the item;

4. Customs clearance must be completed via Beijing Customs;

5. Items falling under the Administrative Measures for the Import of Drugs must still go through legal import filing procedures.

V. Documents for Application

Required documents include an application form, a copy of the legal registration certificate of the applying organization, an application report, a letter of commitment, the proof of foreign approval for the item to be imported (if available), a copy of the certificate of origin (if available), a copy of the goods contract, and any other documents deemed necessary.

VI. Application Time

Applications can be submitted at any time. The whitelist will be updated and published monthly based on eligibility assessments.

VII. Retention Period

All documents must be retained until the conclusion of the annual corporate income tax reconciliation period.