The Health Department promotes a graded diversion mechanism for the approval of traditional Chinese medicine registration applications

The Department of Health announced on Thursday (20th) that it will implement a trial arrangement for "graded and streamlined review and approval of registration applications for traditional Chinese medicine" starting from January 1, 2026. In addition to the existing processing methods, two new levels, "innovative drugs" and "designated priority products," will be added, along with specified target processing times. The new arrangement aims to expedite the processing of registration applications for the new levels, assist applicants in more effectively planning their business and resources, and align with Hong Kong's policy to develop into an international medical innovation hub.

The Assistant Director of Health (Traditional Chinese Medicine), Fang Haocheng, stated that enterprises in Hong Kong and mainland China only need to hold a wholesaler or manufacturer license for traditional Chinese medicine issued by the Hong Kong Chinese Medicine Management Committee (the Committee) to select suitable traditional Chinese medicine products through the graded and streamlined mechanism for expedited entry into the Hong Kong market. The Department of Health will complete the approval for the "innovative drugs" level within 120 working days and submit it for approval by the Chinese Medicine Management Group (the Group) under the Committee.

In addition, applicants can select up to two products each year as "designated priority products," and the Department of Health will complete the review and submit it for Group approval within 150 working days. Compared to the current general application process, which takes more than 250 working days to complete the review, the new mechanism can significantly speed up the process, helping the industry select products to test market reactions first, establish product positioning, and use Hong Kong as a springboard to expand into international markets.

To assist the industry in understanding the new mechanism, the Department of Health has already notified licensed traditional Chinese medicine wholesalers and manufacturers by letter in mid-month and will hold online seminars every month from this month until January next year to introduce the details