China – Drug Approval Reform

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China’s Food and Drug Administration has started implementing key reforms that are likely to be a game changer for pharma companies eyeing the Chinese market.  The presentation below highlights the key reforms:



Key Takeaways:

  1. Leveling of Phase 1 playing field: Pharma companies can run a phase 1 trial in china simultaneously as they run Phase 1 trial outside of China
  2. Multi Regional Clinical Trials are acceptable – CFDA would also allow foreign companies to use MRCT data to support NDAs in China as long as the trial design fits China’s technical guidelines. The operative phrase being multi regional, it is likely that CFDA will do a case by case assessment of which trials are acceptable for an NDA filing in China
  3. Foreign made products can apply for an NDA in China – Now, companies wouldn’t have to get NDA approval in the U.S. first; they could directly apply for an NDA or importation to China even if the product is manufactured outside of China. The companies are likely to use their MRCT for an NDA filing and approval. This would in turn, allow them to export their product to China
  4. Expansion of the Green Channel or the Fast Track Pathway – The CFDA expanded the pathway to allow more types of drugs to access the green channel e.g. drugs that target high unmet needs in China, innovative drugs using advanced technology, imported innovative drugs manufactured in China, pediatric drugs, geriatric drugs among other medicinal categories
  5. Speeding up the Clinical Trial Authorization – the CFDA is committed to approving CTAs within 6-9 months (versus 12-18 months earlier)
  6. Emulating the FDA on post approval inspections and increasing the scrutiny on generics (specially those made before 2010) – CFDA is asking the Gx Mfrs to redo the PK and BE studies for products approved before 2010



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Sakshi Saini
Sakshi Saini
Sakshi has a passion for healthcare and innovation in medical techs (Rx and devices). Her ability lies in providing an "outside-in" perspective to colleagues involved in the design, development and commercialization of medical innovation. She comes with a wide range of experience in the oncology space pertaining to both solid tumors and blood malignancies (Lung, Colorectal, Melanoma,AML and MDS).She works with RAS clients to provide activities related to market research and competitive intelligence. She is also a member of European Society of Clinical Oncology.

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