DH introduces tiered and streamlined mechanism to expedite registration of proprietary Chinese medicines, helping businesses tap into global markets

******************************************************************************************

     The Department of Health (DH) announced today (November 20) that, starting from January 1, 2026, it will launch a pilot programme to streamline the evaluation and approval process for proprietary Chinese medicines (pCm) registration applications. Along with the existing processing procedures, two new tiers will be introduced, namely "Innovative Drugs" and "Designated Priority Products", with specified target processing times. The new arrangement aims to expedite processing of registration applications under these new tiers, and allow applicants to plan their business and resources more effectively. This initiative aligns with the policy of developing Hong Kong into an international health and medical innovation hub.

     "Enterprises in Hong Kong and the Chinese Mainland holding a wholesaler or manufacturer licence in pCm, issued by the Chinese Medicines Board (CMB) under the Chinese Medicine Council of Hong Kong (CMCHK), may leverage the new mechanism to quickly bring suitable pCm products to the Hong Kong market. The DH will evaluate "Innovative Drugs" within 120 working days and submit them to the Chinese Medicines Committee (the Committee) under the CMB for approval. Furthermore, applicants may designate up to two products annually as "Designated Priority Products". The DH will complete the evaluations for these products within 150 working days and submit them to the CMB for approval. Compared to the current average processing time, which takes over 250 working days, the new mechanism will significantly accelerate the process and enable the industry to select products to test the market response, establish product positioning and use Hong Kong as a springboard to tap into global markets," the Assistant Director of Health (Chinese Medicine), Dr Edmund Fong, said.

     Applicants may refer to "Frequently Asked Questions 5.B.25" on the CMCHK website for details regarding the definitions of each tier, target processing times, and requirements for supplementary documents during the approval stages.

     To help the industry better understand the new mechanism, the DH has notified licensed pCm wholesalers and manufacturers via letters in mid-November. Online seminars detailing the mechanism will be held monthly from now until January next year. Interested parties may visit the CMCHK website for details.

     The new mechanism will be piloted for two years. The CMB will continuously review its operation and effectiveness, making timely adjustments for optimisation.

Ends/Thursday, November 20, 2025
Issued at HKT 18:42

NNNN

Archives Yesterday's Press Releases

Back to Index Page

Today's Press Releases