Classification | Items | Cost for Registration | |
Domestic Drugs | Imported Drugs | ||
1 & 2 | Clinical trials | RMB 192,000 | RMB 376,000 |
Manufacture/Market | RMB 432,000 | RMB 593,900 | |
3 & 4 | Manufacture/Market without Clinical trials | RMB 183,600 | / |
Manufacture/Market with Clinical trials | RMB 318,000 | / | |
5.1 | Clinical trials | / | RMB 376,000 |
Manufacture/Market | / | RMB 593,900 | |
5.2 | Manufacture/Market without Clinical trials | / | RMB 367,600 |
Manufacture/Market with Clinical trials | / | RMB 502,000 | |
Variation Application | General items | RMB 9,600 | RMB 9,600 |
Technical review items | RMB 99,600 | RMB 283,600 | |
Registration Renewal | RMB 29,700 (Beijing) | RMB 227,200 | |
Note:
1. The drug registration fee shall be calculated and charged according to one API or one preparation. If another specification is added, the registration fee shall be increased by 20% according to the corresponding category.
2. The registration fee for imported drugs shall be added with the foreign inspection transportation expenses, accommodation expenses and board expenses on the basis of the corresponding category.
