Opportunity and Infuence forLocalized DevelopmentPharmaceutical R&D Trends in China1%4%33%32%31%35%21%43%201120145,877Applications7,829ApplicationsInnovatorsGenericsLabel changesOthersFig 1: R&D pipeline growth (2011-2014)China Chemical Drugs Applications StructureSource: Center for Drug Evaluation at China Food and Drug AdministrationA shifting landscape a key implicationsThe Chinese government has made signifcant multi-prongedinvestments to grow the local R&D industry. The aggregateresult is increased local R&D output, a more innovative R&Dpipeline (Fig 1) and Chinaˉs growing importance in supportof global and regional study submissions.Great fux in R&D regulatory reformLaunching local clinical studies for overseas clinical programshave traditionally been challenged by two main barriersin China: the China Food and Drug Associationˉs (CFDA)requirement that a drug be registered in a foreign country orin phase II or phase III clinical trials and a lengthier process forIND and NDA registration than in other markets. Altogether,these barriers can cause local product launches to take fve toeight years, discouraging innovative programs from enteringChina by eroding larger revenues from patent protection.Though the government is accelerating R&D regulatoryreform, large volatility has been seen and is expected tocontinue. For example, in 2014, the CFDA and R&D BasedPharmaceutical Association Committee (RDPAC) had severalexchanges with seemingly opposite results. Despite a recentannouncement from the CFDA about a pilot reform potentiallycutting IND approval times for oncology drugs from one-two years down to 60 days, potential impacts on overseasdevelopment programs in China remain unknown, and morediscussions are still required to defne the specifc reformagenda and timeline. Furthermore, identifying whether centralor local regulatory agencies have the capacity to implementreform has always been a challenge, which could increasevolatility in the near term.This fux can have a large impact on MNC pharmas wantingto import innovative programs to China. The companiesmust change their current global R&D models to mitigate theeffciency risk introduced by Chinaˉs local policy environment.Growing need for °Made for China± drugsAddressing unmet needs specifc to Chinese patients is a keylever for expediting the CFDA approval process. For manyunder-represented but rapidly growing Therapeutic Areas(TAs), such as liver and gastric cancer (Fig 2), there is a strongrationale for fast-track qualifcationaif superior clinicalresults from mainland China, backed up by data from Asianpopulations in global trials, can be demonstrated.As Chinaˉs government continues to face gaps in the quality of and access to healthcareain addition to the growingburdens of population size, ageing and utilization o
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