As mentioned recently in our newsletter, Hong Kong’s Health Authority is being bulked up to take more responsibility in approving healthcare products. This past summer, the Department of Health set up the Hong Kong Centre for Medical Products Regulation. Whereas in the past, Hong Kong looked closely at overseas approvals before registering healthcare products in Hong Kong, this group will now do more analysis internally too.
Instead of requiring 2 approved foreign health authority approvals for drugs, Hong Kong will now only require one health authority approval plus their own internal review. This new policy will apply to all new chemical entities and also innovative drugs. In addition, this new policy will also include vaccines, gene therapy, etc.
Besides Hong Kong, the new policy will also mean better access for foreign drugs and devices in the Greater Bay Area(GBA) – since registration in Hong Kong means that these products can be used in the GBA in qualified hospitals, which include close to 70 million Chinese. This will provide another way for foreign healthcare companies to sell in mainland China, even if they have not gone through the mainland Beijing NMPA review process yet. As a result, to date, many foreign healthcare companies are now contacting the Hong Kong health authority for drug and device approvals (over 100 companies) and six new drugs have already been included in the Hong Kong Hospital Authority Drug Formulary including a CAR-T product for oncology patients.
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.