Over 40 Drug Applications Rejected as CDE Tightens Review Standards

On October 11, the NMPA issued 43 items without drug approval numbers "Notice", which means the failure of several blockbuster varieties to reach the market.

The notifications issued by the National Medical Products Administration (NMPA) have multiple meanings: they can either indicate an approval or a notice of non-approval, with the main difference being whether a batch number is attached.

• Innovative Drugs:In the notice issued on the 11th,Fosun PharmaceuticalSelf-developedNew Class 1 Lung Cancer Drug: Succinate Fruquintinib Capsules,Nicotine Oral Spray Agent Distributed by Johnson & JohnsonAmong the heavyweights.

• In terms of generic drugs:Previously embroiled in the controversy over the withdrawal of original research products from the market,Obeticholic Acid, domestically produced generics have been rejected one after another, leaving only the two acceptance numbers of Fudan Zhangjiang in the review process. The notice issued on the 11th meansObeticholic AcidAll generics have failed.Fosfomycin Trometamol Granules, it received the sixth notification of disapproval.

Based on the recent increase in the number of notifications, industry insiders speculateCDE Review Becomes StricterIn addition, a rough statistical analysis of the industry since January 1, 2023, shows that among the applications that failed to pass approval, the proportion of new drugs was the highest.

Source: Zoelines

The reasons for non-approval may include:

1) New Drug:

Issues such as irrational choice of dosage form or administration route, violation of clinical diagnosis and treatment principles, lack of supporting efficacy data, existence of safety concerns, unreasonable clinical trial design (e.g., insufficient sample size, inappropriate control group selection, unscientific study endpoint settings), quality controllability issues, modified new drugs without significant clinical advantages, and authenticity or data reliability issues discovered during on-site inspections.

2) Generic Drugs:

Cannot be exempted from clinical trials, unreasonable selection of reference preparations, unreasonable selection of clinical specifications, non-approval of preparations due to raw material quality research issues, unreasonable process design (e.g., terminal sterilization required), defects in quality/stability research, centralized handling and discouragement of special varieties, discovery of authenticity or data reliability issues during on-site inspections, etc.

Sina Medicine Comprehensive

Join the reader communication group:

Business Cooperation:Xiaoyu Yang 15210041717