Monthly Archives: March 2019

eCTD submissions in China – next step has been taken

In November 2018, we released a press release regarding the Chinese NMPA, noting that the agency selected our docuBridge and eValidator solution as an eCTD data management system. Now, the next step has been taken towards introducing eCTD submissions in China.

The CDE of the NMPA published the Chinese eCTD specification on March 1, 2019. Comments are appreciated until April 1, 2019. This marks an important milestone in China´s eCTD project, beginning the countdown to the final implementation of eCTD submissions in China.

Because of our involvement in this project, we can offer our customers around the world a head start in meeting China´s new eCTD submissions requirements. Please feel free to contact us or ERIS, our distributor for LORENZ e-regulatory affairs solutions in mainland China, regarding inquiries and further collaboration.