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Real World Evidence (RWE) Becoming More Important In China

  • 1.  Real World Evidence (RWE) Becoming More Important In China

    Posted 11-Jul-2022 16:31
    RWE or real-world data are now becoming more important for drug and medical device approvals and reimbursement in China. Since 2019, when Hainan Island released regulations emphasizing the value of RWE, similar RWE regulations have also been issued by the NMPA for both drugs and devices. Such evidence can increase approvals for products involving rare diseases, pediatric diseases where the diseases progress quickly or are life-threatening, various surgical procedures that are difficult to perform, etc. In addition to Hainan Island, RWE can be helpful for approvals in the Greater Bay Area, and also in the Shanghai Pudong Free Trade Zone recently too. For product reimbursement, RWE can help payers better determine the value of innovative treatments. RWE provides good information on long-term benefits and thus helps payers determine real economic benefits. More foreign drug and device companies should use RWE to positively impact their China strategy.

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    Ames Gross
    President
    Pacific Bridge Medical
    Bethesda, MD
    www.pacificbridgemedical.com
    contact@pacificbridgemedical.com
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