Medical Policies Weekly
1.NMPA released the 42nd batch of list of generic drug reference preparations
On June 25, after review and determination by the Expert Committee of the Quality and Efficacy Consistency Evaluation of Generic Drugs of NMPA, NMPA formally released the "List of Generic Drug Reference Preparations (42nd Batch)".
2.CDE issued the "Guidelines for Acceptance and Review of Biological Products Changes (Trial)"
On June 22, CDE issued the "Guidelines for Acceptance and Review of Biological Products Changes (Trial)", which will be implemented on the date of issuance. The guidelines include seven parts: ①scope of application: supplementary application items for biological products approved by NMPA (including supplementary application items during drug clinical trials); ②accepting department: CDE of National Medical Products Administration; ③Basic data requirements, including the sorting of application forms and filing materials; ④The key points of formal review, including the key points of the application items, the key points of the application form, the key points of the application materials and other points; ⑤The acceptance review decision, including acceptance, correction, rejection and acceptance flow chart; ⑥ others; ⑦ annex.
3.CDE issued the "Technical Guidelines for the Study of Pharmaceutical Changes in Listed Biological Products (Trial)"
On June 25, CDE issued the "Technical Guidelines for the Study of Pharmaceutical Changes in Listed Biological Products (Trial)", which will be implemented on the date of issuance. The guidelines are intended to explain the basic ideas and concerns of the research on changes in the registration and management of listed biological products from a technical perspective. They are applicable to preventive biological products, therapeutic biological products and in vitro diagnostic reagents managed by biological products. The main content including basic considerations, change classification, communication, common change categories and technical requirements of biological products, etc.
4.CDE publicly solicits opinions on "Working Procedures for Changes in Drug Registration Application Review Period"
On June 23, CDE issued the "Working Procedures for Changes in Drug Registration Application Review Period (Draft for Comments)" for public comment. The time limit for comment is two weeks from the date of issuance. The draft for comments includes three parts. The first is the scope of application and basic compliance. It clarifies changes applicable to various drug registration applications review period and requires the applicant can only propose one change within the limited time, guarantee fairness and justice and consistent standards on the basis of the evaluability of the original application items. The second is to clarify the acceptable changes and corresponding working procedures during the review period of various drug registration applications. The third is to clarify those changes in the review process of APIs can be implemented with reference to preparations.
5.The 2020 drug review report is officially released
Recently, CDE issued the "2020 Drug Evaluation Report" (hereinafter referred to as the "Report"). According to the "Report", 59 new crown virus vaccines and new crown pneumonia treatment drugs registration applications were included in the special approval process and completed the technical review; a total of 1062 registration applications for category 1 innovative drugs (597 varieties) were accepted, an annual increase of 51.71%compared with 2019; 208 new drug marketing applications passed the review, an annual increase of 26.83% compared to 2019; 20 new drug marketing applications passed the review (14 category 1 chemical drugs, 4 innovative Chinese medicine drugs, and 2 innovative biological products) ), 72 varieties (including new indication varieties) for the marketing applications of overseas-produced original drugs passed the review.
