The importing of pharmaceuticals is generally restricted by price, customs regulations, and complex licensing procedures. It is important for the applicant who wants to enter the China drug market to understand the general registration procedure for importing drugs. The below registration procedure is set forth based on the relevant provisions of the State Drug Administration.
1. Submit Application - Applicant submits completed application form and all required documents to the Department of Drug Registration (DDR) of the State Drug Administrative (SDA).
2. Format Inspection - DDR performs a preliminary inspection of the completeness of the submitted documentation. (20-30 days)
3. Acceptance and Fee Payment - DDR issues an acceptance and fee payment notice to the applicant, and the applicant pays such fee. (3-8 days)
4. Technical Evaluation
- DDR requests SDA Drug Evaluation Division (DED) to carry out technical evaluation. (3-5 days)
- DED carries out initial evaluation of the documentation, and either rejects the application, or plans an Expert Evaluation Meeting. (40-120 days)
- DDR holds Expert Evaluation Meeting (twice a year, normally in May and November). (30-180 days)
- DED reviews outside experts' opinions and combines them with their own in a report submitted to DDR. (15-60 days)
5. Technical Laboratory Re-examination - National Institute for the Control of Pharmaceutical & Biological Products tests the samples provided by the applicant. (40-100 days)
6. Approval of Clinical Trial - DDR issues an approval to the applicant to undergo clinical trials. (20-30 days)
7. Clinical Trial - Applicant conducts clinical trials in the appointed hospitals and submits the results to DDR. (50-80 days)
8. Integrated Evaluation Result - DED, according to the clinical trial results, submits an integrated Evaluation Report to DDR. (15-60 days)
9. Report and Approval
- DDR submits an Evaluation Report to SDA. (12-40 days)
- SDA Director signs approval. (12-40 days)
10. Issue Certificate - DDR issues a Registration Certificate to the applicant. (5-20 days)
The total duration of the process for registering pharmaceuticals can vary from 265-773 days.