1. Pink Sheet

China FDA Lays Out eCTDs, Bioequivalence, Patent Linkage As Priorities

 
• By Brian Yang

Surprise announcement by China FDA to roll out an electronic common technical document system by year-end is causing jitters in the pharma industry, but other moves to raise product quality and strengthen patent linkage seem more positive for manufacturers.

concept graph brain wave EEG

In a significant and surprise regulatory step forward, China has made digital filings of new drug applications a priority for 2017.

“We will set up a new drug electronic common technical document (eCTD) system and the goal is to start digital filing and drug reviews by the year-end,” China FDA

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from China

More from Asia