China Annual NDA Report Sheds Light On SFDA Thinking, Highlights Pediatric Indications, Orphan Drugs
This article was originally published in The Pink Sheet Daily
Executive Summary
China’s State FDA handed out 242 new, and 336 abbreviated new, drug approvals in 2012. Pfizer’s Sutent was one of two products that gained a nod without the need for clinical trials.
You may also be interested in...
Insider Analysis From Easton Associates: Are Patient Assistance Programs The Silver Bullet To Meet Affordability Challenges In China?
By Celia Deng, Zhiyi Tong and Paul Zhang
Medtechs Must Reflect On China Localization Policies As VBP Expands
China continues to roll out volume-based procurement for medical devices and pharma products and companies should plan their strategies accordingly, advises EY Parthenon’s Hua Su.
China VBP, Localization And Other Strategies - How Far And Which Way?
Could health sector players encounter issues similar to those facing Tesla in China, a country which virtually saved the electric vehicle maker but where it is now facing challenges? Are there any lessons to be learned from a success story under China's volume-based procurement scheme? A partner at EY looks at these and other issues in an interview with Scrip.