What: Webinar – Navigating eCTD Submissions in China
When: Tuesday, September 14th at 9 am (EST)
Where: Online Event
How: Register Here
Why: Join us for a webinar that will examine the requirements for China eCTD submissions and how to develop strategies for compliance.
With the rapid growth of the Chinese pharmaceutical market, more and more companies from overseas would like to launch their products in China while the domestic companies in China plan to globalize their product development. During interactions with health authorities, CTD and eCTD submissions are widely used all over the world to organize and submit regulatory dossiers in a globally harmonized format. China’s health authority, the National Medical Products Administration (NMPA) has also published drafts for Chinese eCTD requirements, technical specifications, and validation criteria to collect public feedback, which could be implemented in the near future.
All eCTD submissions in China will be unique due to the usage of the local language and their specific regulatory requirements; these are challenges that sponsors planning to submit dossiers must be prepared for. This webinar will introduce the requirements for China eCTD submissions and how to develop strategies to comply with them.
Join this featured presentation led by Regulatory & eCTD Solution Expert, James Ma, who will share his perspective on how to navigate eCTD submissions in China and the challenges that sponsors must be prepared for.
Celegence will be hosting this WEBINAR on Tuesday, September 14th at 9 am EST. Register online now!