1. Scrip
  2. >>Focus On Asia
  3. >>China

‘Made In China’ Provision Removed From Green Channel Policy

 
• By Varun Saxena

The original draft of an accelerated approval policy in China for innovative devices included a condition that a product being considered for the special pathway “is produced in China.” That condition has been removed from the latest draft following pressure from the U.S. government.

Under pressure from the U.S. government, Beijing removed regulatory language stating that innovative devices must be produced in China to be eligible for accelerated approval under what is known as the green channel policy.

The original draft, released in the spring, had four conditions for eligibility, including a requirement that the product being considered...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip 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

US Tariff Overhang Weighs on Chinese API Exports

 
• By Dexter Jie Yan

Chinese API exports to the US fell by 24% year-on-year to $255m in May, when the US and China called a truce in a previously escalating trade war.

Chinese Developers Showcase Potentially Differentiated Weight Loss Assets At ADA

 
• By Xu Hu

Multiple Chinese firms presented at this year’s ADA meeting, with a focus on weight reduction efficacy for mostly early clinical stage assets. While limited information was given on lean mass preservation, several companies are progressing drugs and combos to address this need.

China Signals Restarting IPOs For Unprofitable Biotechs

 
• By Dexter Jie Yan

The China Securities Regulatory Commission has proposed a new “growth tier” for the STAR Market of the Shanghai Stock Exchange, to reinstate the market’s listing standards for unprofitable firms.

Innovent Builds Metabolic Pipeline While Retaining Oncology Backbone

 
• By Xu Hu

Innovent presented data on multiple pipeline assets at ASCO, including promising OS results for its first-in-class anti-PD-1/IL-2α-bias bispecific. The Chinese firm is also continuing to build out its metabolic disease portfolio and consider its partnering strategies, its CEO tells Scrip.

More from Focus On Asia

Battle For Obesity Market Shifts Gears in India: Will Wegovy Trump Mounjaro?

 
• By Anju Ghangurde

Novo Nordisk debuts Wegovy in India, gears for pole position in obesity. The Danish group’s leadership doesn’t appear too perturbed about the head start for Lilly’s Mounjaro or the imminent arrival of generic semaglutide next year.

Bitcoin Player Parataxis To Acquire Bridge Biotherapeutics After IPF Failure

 
• By Jung Won Shin

After the failure of its lead asset in a Phase II trial earlier this year, Korea's Bridge Biotherapeutics has accepted an acquisition offer from bitcoin group Parataxis.

Chinese Developers Showcase Potentially Differentiated Weight Loss Assets At ADA

 
• By Xu Hu

Multiple Chinese firms presented at this year’s ADA meeting, with a focus on weight reduction efficacy for mostly early clinical stage assets. While limited information was given on lean mass preservation, several companies are progressing drugs and combos to address this need.