1 min read
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 sector.
Additionally, one of the major drawbacks could be facing challenges in ensuring that their eCTD submissions are consistent with their paper submissions and that the content of the dossier is consistent for both eCTD and paper submissions. The documents need to be submitted in Mandarin with English versions as a reference, which can be a difficult task for companies that are not fluent in the language.
Navigating eCTD Submissions in China
With the dynamic expansion of the Chinese pharmaceutical market, an increasing number of international enterprises are venturing to introduce their products within China's borders. Meanwhile, domestic Chinese companies are mirroring this growth by extending their product development endeavors worldwide. When engaging with health authorities, the global adoption of CTD and eCTD submissions has become prevalent, providing a standardized avenue for compiling, and presenting Regulatory documentation.
To navigate these intricacies, pharmaceutical organizations require a prospective dossier submitter to equip themselves with effective strategies and must be aware of the following to mitigate any errors while drafting them:
- The Evolving Regulatory Landscape for eCTD Submissions in China
- How to Comply with China's eCTD Requirements
- The Benefits of Using eCTD for Submissions to China
- Tips for Navigating eCTD Submissions in China
To simplify the understanding of the aforementioned, Freyr brings in a free webinar on “Navigating eCTD Submissions in China,” scheduled for August 29, 2024.
Register now and gain exclusive insights! Stay safe. Stay informed.
