As mentioned in previous newsletters, foreign drug and device companies can gain quicker access to China’s healthcare markets if they first register their products either on Hainan Island or in the Greater Bay Area. On Hainan Island, hospitals can apply for unregistered products in China if these products have already been approved overseas and are in high demand. Real-world data from Hainan Island can be used to expedite approval in mainland China.
Another strategy is registering in Hong Kong and/or Macao and then registering in the Greater Bay Area. The Greater Bay Area includes 9 cities in Southern China and about 90 million people. Since last year, approvals in Guang Dong province have been simplified and greatly expedited. These approvals have meant local Chinese are able to access products never before available. To date in Guangdong province, over 21 drugs and 14 various medical devices have been approved.
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.
Source used in the article: https://www.mckinsey.com/industries/healthcare/our-insights/health-care-in-china-entering-uncharted-waters