8 things you need to know about eCTDs in China
At the end of 2021, China implemented electronic Common Technical Document (eCTD) submissions to accelerate the review and approval of new pharmaceuticals. eCTDs ultimately benefit pharmaceutical and biotech companies by expediting review times, which means faster approvals and a faster time to market. For the regulatory authorities, eCTDs enable more efficient review processes. Although this is a huge step forward for standardization in the Asia Pacific, there are several important things you need to know before you submit your dossier electronically.
Here are eight things you need to know.
Related Insights
Video
Overcoming asset transfer challenges during a merger and acquisition (M&A)
Oct 20, 2021
Blog
Focusing on value drivers to reduce risk in early-stage drug development
Jan 6, 2025
Article
Near-term strategies for biotech drug developers facing shifting healthcare dynamics
Feb 14, 2024
Playbook
What emerging trends in the FDA’s most coveted designations might tell us
Feb 8, 2024
Blog
Studying multiple versions of a cellular or gene therapy product in an early-phase clinical trial
Nov 19, 2021
Article
How a joined-up development strategy pays off for early-stage biotechs
May 19, 2021
Article
Expedited Pathways Comparisons - US EU CHN
Oct 19, 2021
Webinar
Assessing appropriate use of ECAs in clinical trials
May 28, 2023
Webinar
Accelerated Early Phase Decision-Making – Insider Insights to Speed Development
Jan 7, 2025
Playbook
Early-phase development strategies for navigating regulatory complexity in the EU
Apr 29, 2024
Blog
Speeding life-changing medicines to patients by minimizing risk in the preclinical stage
Jan 22, 2025
Blog
Proof of product safety and efficacy: how to move ahead successfully in Phase 2 clinical development
Jan 22, 2025
Related Insights
Video
Overcoming asset transfer challenges during a merger and acquisition (M&A)
Oct 20, 2021
Blog
Focusing on value drivers to reduce risk in early-stage drug development
Jan 6, 2025
Article
Near-term strategies for biotech drug developers facing shifting healthcare dynamics
Feb 14, 2024
Playbook
What emerging trends in the FDA’s most coveted designations might tell us
Feb 8, 2024
Blog
Studying multiple versions of a cellular or gene therapy product in an early-phase clinical trial
Nov 19, 2021
Article
How a joined-up development strategy pays off for early-stage biotechs
May 19, 2021
Article
Expedited Pathways Comparisons - US EU CHN
Oct 19, 2021
Webinar
Assessing appropriate use of ECAs in clinical trials
May 28, 2023
Webinar
Accelerated Early Phase Decision-Making – Insider Insights to Speed Development
Jan 7, 2025
Playbook
Early-phase development strategies for navigating regulatory complexity in the EU
Apr 29, 2024
Blog
Speeding life-changing medicines to patients by minimizing risk in the preclinical stage
Jan 22, 2025
Blog
Proof of product safety and efficacy: how to move ahead successfully in Phase 2 clinical development
Jan 22, 2025