As the country has issued new drug registration fees, the editor can understand the new drug registration fees and generic drug registration fees. For the supplementary application fees, it is a bit dizzy. First, there are as many as 36 supplementary application items. Second, the same supplementary application items may also have regular items and items requiring technical review, and the charging standards are quite different.

　　 Drug registration fees

　　 Note: 1. Drug registration fees are calculated based on one API or one preparation for one variety. If another specification is added, the registration fee will be increased by 20% according to the corresponding category. 2. The supplementary application items for drugs that are filed by the provincial food and drug regulatory authority or directly filed by the food and drug regulatory authority of the State Council in the <Drug Registration Management Measures> do not charge supplementary application registration fees. Such applications are considered to be technically required after review. In the case of review, the applicant shall pay the fee in accordance with the fee standard for supplementary applications requiring technical review. To

　　3. For a one-time import of drugs, a drug registration fee of 20 thousand yuan will be charged. To

　　4. The registration fee for imported drugs is based on the corresponding domestic registration fee plus the difference between domestic and foreign inspection transportation, accommodation and food expenses. To

　　 5. Hong Kong, Macao, and Taiwan drug registration fee standards are implemented in accordance with the import drug registration fee standards. To

　　6. ​​Expedited fees for drug registration shall be formulated separately.

　　 In order to clarify the relationship, I found Annex 4 of Order 28, the original text remarks the cost of each item, I suggest my colleagues to save this article in case of emergency. To

　　Annex 4: Drug Supplementary Application Registration Items and Application Document Requirements

I) Fees

There is no free lunch in the world! And now the charges are not cheap! The starting price (the so-called regular item) starts from 96,000 yuan, and the technical review item is 96,000 yuan. The entire first registration item requires money drops, note Lah! Every time the boss says to change in the future, remember to remind me how much it will cost!

　　 1. Registration matters

　　(1) Supplementary application items approved by the State Food and Drug Administration:

　　 1. The approval number of a drug manufacturer holding a new drug certificate to apply for the drug. (Require technical review items, charge 99,600 yuan)

　　 2. Use the name of the drug product. (Regular items, a fee of 9,600 yuan)

　　3. Increase the functions and indications of traditional Chinese medicine, natural medicine indications, or chemical medicines and biological products that have been approved in China. (Required technical review item, charge 99,600 yuan)

　　 4. Change the usage and dosage or change the scope of the applicable population without changing the route of administration. (Required technical review item, charge 99,600 yuan)

　　 5. Change drug specifications. (Required technical review item, charge 99,600 yuan)

　　 6. Change the excipients that are required for medicinal purposes in the drug prescription. (Required technical review item, charge 99,600 yuan)

　　7. Change the production process that affects the quality of medicines. (Require technical review items, charge 99,600 yuan)

　　 8. Revise drug registration standards. (Require technical review items, charge 99,600 yuan)

　　9. Substituting or subtracting toxic medicinal materials or medicinal materials in an endangered state in the national drug standard prescriptions. (Require technical review items, charge 99,600 yuan)

　　 10. Imported drugs, domestically produced injections, ophthalmic preparations, aerosols, powder mists, and sprays are changed to packaging materials or containers that directly contact drugs; use new packaging materials or containers that directly contact drugs. (Require technical review items, charge 99,600 yuan)

　　11. Apply for drug combination packaging. (Require technical review items, charge 99,600 yuan)

　　 12. Technology transfer of new drugs. (Require technical review items, charge 99,600 yuan)

　　 13. Revise or add items such as Chinese medicine, natural medicine instructions, Chinese pharmacology and toxicology, clinical trials, pharmacokinetics, etc. (Require technical review items, 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 validity period of the drug, and the packaging specifications. (Change the name of the pharmaceutical manufacturer, registered address, packaging specifications, conventional items, and charge 96,000 yuan) (Change the name of the drug, the validity period of the drug, require technical review items, and charge 99,600 yuan) 　

　　 15. Change the origin of imported medicines. (Require technical review items, charge 99,600 yuan)

　　 16. Change the foreign packaging factory of imported medicines. (Change foreign packaging plants that do not directly contact drugs, conventional items) (Change foreign packaging plants that directly contact drugs, require technical review items, and charge 99,600 yuan)

　　 17. Imported medicines are packaged in China. (Require technical review items, charge 99,600 yuan)

　　 18. Others. (No technical review required, regular items, a fee of 9,600 yuan)

　　二), free matters:

There is still a free lunch in the world! The simple summary is that the filing items are all free! According to the instructions in the <Registration Standards of Drugs and Medical Devices>: <Drug Registration Management Measures> belong to the provincial food and drug administration department for the record Or the supplementary application items directly filed by the Food and Drug Administration of the State Council do not charge the supplementary application registration fee. If such an application is reviewed and deemed to require technical review, the applicant shall follow the fee standard for supplementary applications that require technical review. Make up fees. To

　　(2) Supplementary application items for imported drugs approved by the Provincial Food and Drug Administration for the record of the State Food and Drug Administration or directly filed by the State Food and Drug Administration:

　　 19. Change the name of the domestic drug manufacturer. (free)  

　　 20. Domestic pharmaceutical production enterprises have internally changed the pharmaceutical production site. (free)  

　　21. Change the packaging materials or containers that directly contact the drug (except for item 10 above). (free)

　　 22. Change the validity period of domestically produced drugs. (free)  

　　23. Change the origin of raw materials used in imported pharmaceutical preparations. (free)  

　　24. Change the appearance of imported drugs, but do not change the drug standards. (free)  

　　 25. Modify the import drug inserts in accordance with the national drug standards or the requirements of the State Food and Drug Administration. (free)  

　　26. Supplement and improve the safety content of imported drug inserts. (free)  

　　 27. Change the packaging labels of imported drugs in accordance with regulations. (free)  

　　 28. Change the import drug registration agency. (free)  

　　29. Others. (free)  

　　(3) Supplementary application items filed by the provincial food and drug administration department:

　　 30. According to the national drug standards or the requirements of the State Food and Drug Administration, modify the instructions for domestically produced drugs. (free)  

　　31. Supplement and improve the safety content of domestically produced drug inserts. (free)  

　　 32. Change the packaging labels of domestically produced drugs in accordance with 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 drug standards. (free)  

　　36. Others. (free)  

　　Excerpt from: Dandelion