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

U.S. FDA Sees Progress Working Within China, And More Help Is On The Way

 
• By Brian Yang

FDA hopes an expanded staff in China will help overcome new hurdles as the agency learns more about the country's manufacturing and quality system processes.

BEIJING – Nearly four years into U.S. FDA's plan to use in-country offices to inspect and analyze Chinese products before they reach U.S. shores, the agency has seen closer collaboration and institutionalized involvement with its Chinese counterparts and a broadened geographic coverage in the country. However, a number of challenges remain, according to FDA's China Country Director Christopher Hickey.

The challenges range from the sheer number of the Chinese producers to the multiple roles Chinese regulators have to play....

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

BlissBio Goes Solo On HER2-Targeting ADC After Eisai Exit

 
• By Dexter Jie Yan

BlissBio is to single-handedly move BB-1701, its eribulin-containing, HER2-targeting antibody-drug conjugate, into a global pivotal Phase II/III program for HER2-expressing, Enhertu-resistant breast cancer.

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.

More from Focus On Asia

Global Pharma Interest In Korea Undeterred Despite Political Roller Coaster

 
• By Jung Won Shin

Despite recent political turmoil, outside investor and corporate interest in South Korean biopharma innovation appears robust or even increasing.

Torrent Acquires JB Chem In 2025’s Biggest Deal For Indian Pharma

 
• By Vibha Ravi

Torrent Pharma’s JB Chemicals acquisition follows the Curatio deal and Boehringer brands buyout. The second-biggest deal ever and the largest in 2025 among domestic pharma companies helps Torrent fill white spaces in areas like nephrology and gives an entry into the CDMO segment

Snapshot Of India’s Pharma Manufacturing Network Amid ‘Trumponomics’

 
• By Anju Ghangurde

Scrip collates data on the global manufacturing network of leading Indian drug makers, the markets serviced and production hubs for active pharmaceutical ingredients. Will ongoing geopolitical tensions and policy shifts have a bearing on some of these down the line?