Goodbye CFDA, Hello MRA: China Overhauls Regulatory Bodies
China proposes to merge its top drug regulator into new combined body, and creates a medical reimbursement agency in move viewed as sign of strengthening regulatory oversight.
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Bigger, Bolder, SMAR: Decoding China's All-In-One Regulatory Agency
A new era began April 10 with disappearance of China FDA and kickoff of State Administration for Market Regulation (SMAR), the so-called 'One-Stop' regulatory agency. Will the CFDA's innovation-encouraging policies continue? How will the new agency balance innovation and enforcement? Pink Sheet offers preliminary answers to these key questions and decode the new SMAR from five important aspects.
Falling At The Start Line: Chinese Firms Face Multiple Commercial Challenges Beyond Price, Coverage
Sales of a global first-in-class dermatology drug that gained its first approval in China are falling well behind those of its overseas counterpart. In this case study, Scrip takes a deep dive into the multiple underlying factors determining success in the world's second-largest pharma market beyond pricing and reimbursement coverage, including complex hospital entry, dual channels and competition considerations.
China Micron Ban Not Cause For Further Health Sector Worry?
China has taken a new counterstrike against the US in the chips sector, but the risk of potential wider impact on the biopharma sector appears to be limited given other tighter regulations already in place.