18 Aug 2016
Enquiry: What are the Registration Procedures for Importing Pharmaceutical Products (Chinese Proprietary Medicine) into China?
The following are the registration procedures for importing pharmaceutical products (Chinese proprietary medicine) into China:
1. Acceptance of application
After an application is submitted to the Administrative Acceptance Service Center of the China Food and Drug Administration, the staff of the Administrative Acceptance Service Center shall examine the application dossier.
2. Drug registration inspection
After an application is accepted by the Administrative Acceptance Service Center, the China Food and Drug Administration shall inform the National Institutes for Food and Drug Control to conduct registration inspection and determine issues related to the approval or review.
After receiving the application dossier and samples, the National Institutes for Food and Drug Control shall arrange drug control institution to conduct registration test within five days. After the receipt of data, samples and standard substances, drug control institutions which undertake import drug registration shall complete the registration test within 60 days and submit the registration test reports to the National Institutes for Food and Drug Control. Special drugs and vaccine products for sample testing and drugs standard review shall be completed in 90 days. After receiving the registration test reports and import drug registration standards having been reviewed, the technical review shall be carried out by experts within 20 days. If necessary, re-review shall be conducted as per review comments.
3. Technical review
While conducting testing for drug registration, the Administrative Acceptance Service Center shall transfer the application dossier to the Center for Drug Evaluation of the China Food and Drug Administration for overall technical review.
4. Administrative permission decision
The China Food and Drug Administration shall review and make permission decisions within 20 days from the date it receives the technical review comments from the Center for Drug Evaluation.
5. Decision delivery
The Administrative Acceptance Service Center shall deliver the administrative permission decision to the applicant within 10 days from the date of issuance of the administrative permission decision.