On July 31, the Standing Committee in Guangdong Province promulgated a new regulation to expedite the approval of urgently needed drugs and devices into China – for products that are already approved in Hong Kong or Macao. The regulation is titled – The Regulation on the Administration of Import of Drugs and Medical Devices from Macao or Hong Kong into the Nine Cities in the Guangdong-Hong Kong-Macau Greater Bay area (GBA) of Guangdong Province. The regulation will go into effect on December 1. Please keep in mind that this geographic region of China includes close to 75 million people and 9 major cities. The main benefit of the regulation is that besides Hainan Island, now the use of urgently approved drugs and devices in the GBA can be considered as Real World Study (RWS) data for future mainland China registrations.
Again, drugs and devices can only be used in the GBA if they have already been approved in Hong Kong or Macao and there is an urgent need in China. Under the new regulation, for products in the import catalog, only 10 days will now be needed for a product review. For products not listed in the import catalog but still in urgent need, 20 days will now be needed for the product review. Besides expediting the review times, the new regulation also requires that the GBA-designated medical institutions using these products must have specialized departments to analyze data and have strong safety and post-marketing requirements. In addition, the new regulation expedites custom clearance and recommends the use of GBA products to be covered by various insurance plans.
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.