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.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.