China has been gradually adopting eCTD submissions since 2017. In 2022, the National Medical Products Administration (NMPA) announced that it would be fully transitioning to eCTD submissions by the end of 2023. This means that all new drug applications submitted to the NMPA must be in the eCTD format. For companies unfamiliar with the process, the Chinese eCTD format is extremely complicated and can be difficult to navigate. This can cause delays in submitting required documentation and, ultimately, in getting products to market.
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.
Companies also need to make sure their eCTD submissions are consistent with their paper submissions and that the content is the same in both formats. The documents must be submitted in Mandarin with English translations, which can be difficult for companies that don't speak 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 September 28, 2023.
Register now and gain exclusive insights! Stay safe. Stay informed.