ClassificationItemsCost for RegistrationDomestic DrugsImported Drugs1 & 2Clinical trialsRMB 192,000RMB 376,000Manufacture/MarketRMB 432,000RMB 593,9003 & 4Manufacture/Market without Clinical trialsRMB

I) Summary 1. Drug name2. Certified documentCertified document of class 5.2 product by register classification3. Purpose and basis of subject selection4. Self-assessment report5. Listed Lice

I) Summary 1. Drug name2. Certified documentCertified document of class 5.1 product by register classification3. Purpose and basis of subject selection4. Self-assessment report5. Listed Lice

The registration classification of chemical drugs is divided into the following five categories: 1. Innovative drugs that are not marketed both domestically and abroadThese drugs (API and its pre

 Provisions of Drug Registration (The measure of Drug Registration is approved by State Administration for Market Regulation in Order No.27 on January 22, 2020) Chapter 1: General

General PrinciplesApplication for Drug RegistrationPre-clinical Laboratory Study of DrugsClinical Study of DrugsApplication and Approval of New DrugsApplication and Approval of Drugs Already withNatio

Requirements for application documents of registration category 4 and 5.2 (trial implementation) I. Items of application documents(I) Summary1. Name of the drug2. Certificates2.1 certificates req

I. Items of application documents(I) Summary1. Name of the drug2. Certificates2.1 certificates required for category 1, 2, 32.2 certificates required for category 5.13. Purpose and basis of the projec

 Item   Import   drug NDAClinical trial37.60Manufacturing/marketing59.39ANDAManufacturing/marketing without clinical trial36.76Manufacturing/marketing with clinical trial50.20Suppl

Chemical drug registration category reform work protocol” was released by CFDA by announcement No.51 on March 4, 2016. The following is the new category:Registration   categoryClassification