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

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.

Henlius CEO Details PD-L1 ADC’s Path To 1L Mono/Combo Therapy

 
• By Dexter Jie Yan

Henlius is investigating the optimum dose for its PD-L1-targeting antibody-drug conjugate HLX43 to support potential first-line use, its CEO explains to Scrip.

AstraZeneca Taps Into China’s R&D Engine With CSPC Alliance

 
• By Andrew McConaghie

After in-licensing a cardiovascular candidate last year, AstraZeneca has signed a strategic drug discovery alliance, which could generate billions of dollars in payments to the Chinese firm.

Chinese Biotech VC/PE Fundings Rise But Still Modest

 
• By Dexter Jie Yan

LTZ Therapeutics and Beijing Sungen Biomedical are among the Chinese biotechs raising new funding, of around $40m each, based on their clinical assets with novel mechanisms of action. While fundings have risen, they remain moderate however.

More from Focus On Asia

AstraZeneca Taps Into China’s R&D Engine With CSPC Alliance

 
• By Andrew McConaghie

After in-licensing a cardiovascular candidate last year, AstraZeneca has signed a strategic drug discovery alliance, which could generate billions of dollars in payments to the Chinese firm.

Is Zydus’s Agenus Deal Opportunistic Or Strategic?

 
• By Vibha Ravi

Will Zydus’s acquisition and licensing deal with Agenus turn out to be a strategic move towards building an oncology portfolio or an opportunistic one driven by a venture capital mindset?

Citeline Japan Awards 2025 - Enter Now!

 
• By Ian Haydock and Lisa Takagi

The 14 July deadline for the Citeline Japan Awards 2025 in Tokyo is approaching fast, so here's a reminder to take a look at the categories and criteria and be sure to get those submissions in by this date. Sponsorship opportunities and tables for the event are also available.