China-Specific Clinical Document Preparation for Simultaneous New Drug Application Submissions to China National Medical Products Administration: Insights from a Multi-Company Survey

Abstract

With China’s increasing participation in global multiregional clinical trials under International Council for Harmonisation (ICH) E17 guidelines, simultaneous submissions to the China Center for Drug Evaluation have become more prevalent. Clinical packages for China simultaneous new drug applications (NDAs) include documents submitted to other health authorities (eg, US Food and Drug Administration [FDA]) and China-specific documents. However, practices for preparing China-specific clinical documents vary across companies. To characterize current practices in China-specific clinical document preparation for simultaneous NDA submissions, facilitate experience sharing, and identify challenges and improvement opportunities, a cross-sectional survey was conducted among pharmaceutical companies with medical writing teams in China. The survey was distributed in July 2025 to 25 companies, with follow-up interviews conducted through September 2025. Questions addressed document preparation practices, team responsibilities, collaboration strategies, and challenges. Seventeen multinational companies were analyzed. Nine companies (52.9%) prepare lean China-specific packages with 1 to 2 documents, whereas others prepare 3 or more documents. Three companies (17.6%) author documents directly in Chinese. For China Subgroup Clinical Study Reports, half employ the same structure as global clinical study reports, whereas half use modified structures; most companies (n = 15, 88.2%) present only key endpoints rather than comprehensive data; approximately half present only China subgroup data. Ten companies (58.8%) use side-by-side table formats for China-versus overall population comparisons. All companies reported that close collaboration between China and global teams is key to success. Current practices for simultaneous submissions vary significantly across the surveyed companies, with adoption or willingness to adopt leaner document packages being a common theme. Cross-functional collaboration and clear communication between global and local teams remain critical elements for successful simultaneous submissions.