China, U.S. FDA Drug Inspections Said Unaffected By Changes In SFDA

The mutual inspection arrangement between the FDAs of China and the U.S. remain unaffected by recent changes in China's regulatory processes for food and drugs.

The mutual inspection arrangement between the FDAs of China and the U.S. remain unaffected by recent changes in China's regulatory processes for food and drugs. The head of the U.S. FDA's China office said in an interview most of the work with the newly renamed CFDA is "business as usual" with no change in day-to-day operations. Each nation is operating under an agreement that allows each to inspect facilities in the other country for its imported products. Christopher Hickey, director of the U.S. FDA operation in China, said it is yet to be determined if the CFDA changes would have an impact on clinical trials, international standards harmonization or approvals of drugs and medical devices. (Click here for more

)

More from China

China-Originated Assets Lead Global GLP-1 Deals

 
• By 

The total deal value of GLP-1-associated assets globally this year is already double that of the previous two years combined, with China-originated assets accounting for a substantial majority.

China’s BRL Gears Up For First UCAR-T Trial In Leukemia/Lymphoma

 
• By 

Shanghai-based BRL Medicine is building a novel pipeline led by universal CAR-Ts. Its founder talks to Scrip about the benefits of this approach, China's potential advantages in the field and challenges faced by new ventures.

BeBetter, Trinomab Advance IPOs On China’s STAR Market In Firsts Since Policy Easing

 

BeBetter becomes first unprofitable innovative drug maker to have application for an IPO on Shanghai's STAR Market cleared by China’s top securities regulator, while Trinomab becomes first among peers to have IPO filing accepted.

Chinese Biotechs Raise New Funds On Potential First-In-Class Assets

 

Helped by their development of novel potential first-in-class therapies, Tcelltech, BioTroy and Xiaolu are among the Chinese ventures to have attracted new funding from investors over the past weeks.

More from Focus On Asia

Japan Results Roundup: Reduced Forex Impact, Uncertain US Tariff Outlook

 
• By 

Most major Japanese firms report generally positive fiscal first quarter results, led by mainstay growth and despite lower currency effects. But the future impact of any US pharma tariffs remains an overhang.

Lupin Confident Of US Growth On Tariff Mitigation, Rides High On Tolvaptan

 
• By 

Lupin is hoping moves like intellectual property transfer for some products to the US will help mitigate the tariff impact even as it counts on growth from planned launches of GLP-1s and biosimilars while riding high on tolvaptan launched in Q1.

China’s BRL Gears Up For First UCAR-T Trial In Leukemia/Lymphoma

 
• By 

Shanghai-based BRL Medicine is building a novel pipeline led by universal CAR-Ts. Its founder talks to Scrip about the benefits of this approach, China's potential advantages in the field and challenges faced by new ventures.