Could China’s CFDA Reforms Have a Positive Impact for US Entrepreneurs?

12 Oct

By James Huang, Research Analyst, LSN


On Monday, the China Food and Drug Administration (CFDA) held a press conference to announce a reform to their regulatory review and approval process for medical devices and drugs. The major takeaways from for these policy changes are as follows:


  • Faster drug/device approval process
    • China has suggested that data from overseas clinical trials can be accepted for use in the drug/device approval process.
    • The guidelines also suggested that fast-track approval would be granted to drugs/devices targeting diseases without therapies, key projects identified by the government, and orphan drugs.

China’s pharmaceutical market is currently the second largest in the world with growth rates of around 9%. These changes should allow for foreign drug companies to enter that market more easily and as a result, warrants a second look for anyone currently developing new and innovative therapeutics. If China becomes an easier market in which to launch a drug, investors may become more interested in products with a strong potential market in China.

Of course, China’s device market also provides a great opportunity  and with the accelerated approval process applying to both drugs and devices, the Chinese market opportunity for new biotech and medtech products definitely deserves a second look.

The draft guidelines that were released also include a few more interesting suggestions such as:

  • Patent Protections
    • The government stated that it would explore a new system to link patent status with the drug approval process.
  • Innovation Incentives
    • Part of the draft suggested providing incentives to promote innovation of new drugs and devices within China.

The full draft can be found here (Chinese) and the CFDA press release can be found here (Chinese).

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