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36 drug registration supplementary application fees, item by item price list!

36 drug registration supplementary application fees, item by item price list!

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 With the release of new drug registration fees, the new drug registration fee and generic drug registration fee are clearly understood. For the supplementary application fee, it is a little dizzy. First, the number of supplementary applications has reached 36. Second, the same supplementary application may also have conventional items and technical review items, and the charging standards are very different.

 
Drug registration fee
Note: 1. The drug registration fee is calculated based on one drug substance or one preparation. If another specification is added, the registration fee will be increased by 20% according to the corresponding category. 2. In the "Administration of Drug Registration", the drug supplement application filed by the provincial food and drug supervision and administration department or directly filed by the food and drug supervision and administration department of the State Council does not charge for the supplementary application registration fee. In the case of review, the applicant shall pay the fee in accordance with the charging standard for the supplementary application requiring technical review.
3. If you apply for a one-time import of drugs, you will receive a registration fee of RMB 0.20 million.
4. The import drug registration fee standard is based on the corresponding domestic registration fee standard and the difference between domestic and international inspection of transportation, accommodation and food expenses.
5. The registration fees for drug registration in Hong Kong, Macao and Taiwan shall be implemented in accordance with the registration fee for imported drugs.
6. The fee for the registration of the drug registration expedited fee shall be separately formulated.
In order to clarify the relationship between them, I found the attachment of the No. 28 Order, the original remarks, and suggested that colleagues collect this article in case of emergency.
Annex 4: Registration of Drug Replenishment Application and Application Requirements
a), charging matters
There is no free lunch in the world! And now the charge is not cheap! The starting price (so-called regular item) starts from RMB 0.96 million, and the technical review item needs RMB 96,000. The entire first registration item requires money, and the note is charged. In the future, every time the boss says that he wants to change, remember to remind him how much it costs!
I. Registration matters
(1) Supplementary application items approved by the State Food and Drug Administration:
1. The approval number of the pharmaceutical manufacturer that holds the new drug certificate to apply for the drug. (Requires technical review, charge 99,600 yuan)
2. Use the drug product name. (conventional item, charge of 0.96 million yuan)
3. Increase the indications of traditional Chinese medicine, indications for natural medicines, or indications approved by chemicals and biological products in China. (Requires technical review, charge 99,600 yuan)
4. Change usage and dosage or change the scope of the applicable population without changing the route of administration. (Requires technical review, charge 99,600 yuan)
5. Change the drug specifications. (Requires technical review, charge 99,600 yuan)
6. Change the prescriptions for medicinal requirements in the drug prescription. (Requires technical review, charge 99,600 yuan)
7. Change the production process that affects the quality of the drug. (Requires technical review, charge 99,600 yuan)
8. Amend the drug registration standard. (Requires technical review, charge 99,600 yuan)
9. Replace or subtract the toxic substances in the national drug standard prescription or the drugs in the endangered state. (Requires technical review, charge 99,600 yuan)
10. Imported drugs, domestically produced injections, ophthalmic preparations, aerosols, powders, sprays, packaging materials or containers that are in direct contact with the drug; use of new packaging materials or containers that directly contact the drug. (Requires technical review, charge 99,600 yuan)
11. Apply for pharmaceutical combination packaging. (Requires technical review, charge 99,600 yuan)
12. Technology transfer of new drugs. (Requires technical review, charge 99,600 yuan)
13. Revise or increase the pharmacology and toxicology, clinical trials, pharmacokinetics and other items in the instructions for Chinese medicines and natural medicines. (Requires technical review, charge 99,600 yuan)
14. Change the registration items of the imported drug registration certificate, such as the name of the drug, the name of the pharmaceutical manufacturer, the registered address, the expiration date of the drug, and the packaging specifications. (Change the name, registered address, packaging specifications, and regular items of the pharmaceutical manufacturer, the fee is RMB 0.96 million) (Change the name of the drug, the validity period of the drug, the technical review item is required, and the fee is 99,600 yuan)
15. Change the origin of imported drugs. (Requires technical review, charge 99,600 yuan)
16. Foreign packaging plants that change imported drugs. (Change foreign packaging factories that are not in direct contact with drugs, routine items) (Change the foreign packaging factory that directly contacts drugs, technical review items are required, charge 99,600 yuan)
17. Imported drugs are packaged in China. (Requires technical review, charge 99,600 yuan)
18. Other. (No technical review, regular items, charge of RMB 96,600)
b), free matters:
There is still a free lunch in the world! Simple induction is that the filing matters are free! According to the instructions in the "Registration Fees for Drugs and Medical Device Products": <Administrative Measures for Drug Registration> belongs to the provincial food and drug supervision and administration department for the record If the application for drug replenishment directly filed by the food and drug supervision and administration department of the State Council is not subject to the supplementary application registration fee, if the application for such application is considered to require technical review, the applicant shall follow the charging standard for the supplementary application for technical review. Pay the fee.
(2) The provincial food and drug supervision and administration department approves the filing of the import drug supplements filed by the State Food and Drug Administration or directly filed by the State Food and Drug Administration:
19. Change the name of domestic pharmaceutical manufacturing enterprises. (free)  
20. Domestic pharmaceutical production enterprises change the production sites of pharmaceuticals. (free)  
21. Change the packaging materials or containers that are in direct contact with the drug (except for item 10 above). (free) 
22. Change the validity period of domestically produced drugs. (free)   
23. Change the origin of the API used in the import of pharmaceutical preparations. (free)   
24. Change the appearance of imported drugs, but do not change the standards of drugs. (free)   
25. Amend the instructions for importing drugs according to the national drug standards or the requirements of the State Food and Drug Administration. (free)  
26. Supplement and improve the safety content of the imported drug label. (free)  
27. Change the label of imported pharmaceutical packaging according to regulations. (free)   
28. Change the registered drug registration agency. (free)  
29. Others. (free)  
(3) Supplementary application items for the record of the provincial food and drug supervision and administration department:
30. Modify the domestically produced drug specifications according to the national drug standards or the requirements of the State Food and Drug Administration. (free)  
31. Supplement and improve the safety content of domestic production drug specifications. (free)   
32. Change the label of domestically produced pharmaceutical packaging according to regulations. (free)  
33. Change the packaging specifications of domestically produced drugs. (free)   
34. Change the origin of raw materials for domestic production of pharmaceutical preparations. (free)  
35. Change the appearance of domestically produced drugs, but do not change the standards of drugs. (free)  
36. Other. (free)   
From: Dandelion