Navigating the Adoption of eCTD Submissions in China
Understanding the landscape of electronic submissions in China has become crucial for pharmaceutical companies aiming to expand their business in this rapidly growing market. With the National Medical Products Administration (NMPA) mandating eCTD submissions for all new drug applications and launching an online portal for electronic submissions, adapting to the evolving regulatory environment is essential. Companies must navigate the complexity of the Chinese eCTD format and local regulatory requirements, ensuring compliance with standards such as the precise Module 1 folder structure, accurate envelope information, specified file formats, and the use of Mandarin Chinese. Additionally, proper utilization of node extensions and Study Tagging Files (STFs), adherence to secure dispatch mechanisms, and approved electronic signatures are vital. By understanding and adapting to these differences, companies can overcome challenges and leverage opportunities within China's healthcare sec...