From FDA Complete Response Letters on the pharmaceutical assessment of chemical drugs:critical deficiencies and review considerations
REN Feng
CHENG Si-qi
JIANG Tao
CHEN Ai-ping
TANG Zhi-quan
ZHANG Jing-chen
Abstract：This paper systematically reviews 156 US FDA Complete Response Letters(CRLs)for chemical drugs,summarizing issues identified in areas such as control of drug substances and excipients,product development,and quality research.From a pharmaceutical review perspective,it elaborates and analyzes the key and commonly overlooked issues.The publicly available CRLs contain numerous reference-worthy questions and constructive recommendations related to review.The analysis reveals that the FDA's review principles and standards are highly consistent with those of China,further demonstrating that China's regulatory capacity has reached a high level since the reforming of the review and approval system.This progress provides solid backing for China's transition from a major manufacturer to an innovator in the global pharmaceutical industry.
Keywords：Complete Response Letterpharmaceutical reviewcomments and suggestionsreview and approvalregulatory capacity
Publication Date：2025-12-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：7( 2490-2496 )