Import Safety Agreement Further Entwines FDA/China Regulatory Process

Chinese manufacturers of certain drugs or active pharmaceutical ingredients selected by FDA will have to meet new registration standards as part of a memorandum of understanding signed Dec. 11 in Beijing by HHS, FDA and China's State Food and Drug Administration

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

More from Archive

More from Scrip

Executives On The Move: Fable Therapeutics Gains CMO From AstraZeneca

Recent moves in the industry include changes at the top at 32 Biosciences, plus new CEOs at Idorsia, Courage Therapeutics and Oncolytics Biotech.

China Signals Restarting IPOs For Unprofitable Biotechs

 

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.

BIO Notebook: Woodcock Calls For Doing The Right Thing, Dealmaking Remains Constrained

 

Highlights from Day Four of the BIO International Convention include Woodcock offering practical advice on rare disease trials, the sorry state of dealmaking mid-year, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.