In accordance with the requirements of Annex 2 of the "Announcement of the Center for Drug Evaluation of the State Food and Drug Administration on Issuing the Guidelines for Acceptance and Review of Chemical Drug Registration (Trial)" (No. 10 of 2020), generic drugs and other eligible situations will be evaluated by the applicant. If it is deemed that it is not necessary or impossible to carry out drug clinical trials and meet the conditions of exempted drug clinical trials, the applicant may directly file an application for drug marketing authorization, and the application form "Other Special Declaration Matters" should be explained at the same time.
: What is the format and style of the CD-ROM submitted at the same time as the paper materials for the drug registration application?
If you submit the CD at the same time, you should use a recordable file-level CD to burn the CD, and put the CD in the CD case. The case must indicate the product name, the reporting unit, the number of CDs in this set, the first CD, and the contact person. Information such as telephone number, etc., stamped with the official seal of the applicant or registered agent. The CD-ROM case should be packaged in the original application materials (the first bag of the first set) and submitted.
: Can an injection with a different specification from the reference preparation apply for consistency evaluation?
1. Aqueous injections with the same concentration as the reference preparation and the different filling volume are acceptable. The specifications within the usage and dosage range after clinical review can be carried out according to the requirements. 2. Aqueous injection varieties with inconsistent concentrations with reference preparations are acceptable. The review needs to be combined with clinical usage and dosage to determine the rationality of specifications. The approved varieties need to be reviewed in accordance with the requirements for quality improvement. After passing the technical review It is not regarded as passing the consistency evaluation; 3. The powder injection type, the specification is equivalent to the filling volume, and the treatment principle of specifications different from the reference preparation can refer to the water injection varieties with the same concentration and different filling volume.
: Can a supplementary application for adding a drug specification be filed together with the application for consistency evaluation?
Consistency evaluation applications are managed by variety, and supplementary applications for new drug specifications are opened for direct declaration of consistency evaluation channels. In order to prevent the abuse of specifications, the newly added drug specifications must conform to the clinically reasonable usage and dosage range and be consistent with the original research (reference preparation).
The domestically marketed original research drugs or original localized products have been included in the "Chemical Generic Drug Reference Preparation Catalog", but due to issues such as accessibility, the preparation applicant chooses the non-imported original research drugs published in the reference preparation catalog for imitation. Can they follow suit? Application for class 4 chemical drugs?
Under the premise that the declared indications are consistent with the approved indications in China, it is approved to declare and accept the chemical drugs in accordance with the 4 categories.
During the application phase of clinical trials of biological products, it is not mandatory to submit manufacturing and verification procedures.
In accordance with the "Announcement of the State Administration of Drug Administration on Issuing the Registration Classification of Biological Products and Requirements for Filing Documents" (No. 43, 2020), the registration classification requirements of preventive biological products, changes in the immunization dose and immunization procedures belong to the registration category 2.5, and the change of the user population belongs to the registration Classification 2.6, should be declared according to drug clinical trials and marketing authorization application channels.
According to the "Administrative Measures for Drug Registration" and Announcement No. 46 of 2020, the clinical trials of drugs approved before the implementation of the new "Administrative Measures for Drug Registration" and the clinical trials of drugs approved after the implementation of the new "Administrative Measures for Drug Registration" are self-approved If the drug has not been started within three years from the date of the trial, the clinical trial license of the drug shall be automatically invalidated, and the subject shall sign the informed consent form as the starting point.
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