Chinese Medicine Council announces that transitional registration of proprietary Chinese medicines will end on June 30
The following is issued on behalf of the Chinese Medicine Council of Hong Kong (CMCHK):
The CMCHK announced today (June 24) that the evaluation and approval process for converting the transitional registrations of proprietary Chinese medicines (pCm) to formal registrations has been completed. The transitional registration system for pCm will come to an end on June 30. By then, all pCms sold in Hong Kong must have valid formal registrations, marking a new chapter in the regulatory regime of Chinese medicine in Hong Kong.
According to the Chinese Medicine Ordinance (Cap. 549), all pCms must be registered with the Chinese Medicines Board (CMB) under the CMCHK before they can be sold, imported or possessed in Hong Kong. The registration of pCm must comply with the stringent requirements of the CMB in respect of safety, quality and efficacy. Taking into account the actual situation of the trade, the Government implemented a transitional measure in the past. PCms manufactured or sold in Hong Kong as of March 1, 1999, and meeting the eligibility criteria for transitional registration, were allowed to continue to be sold during the application period for "Certificate of registration of pCm" (HKC) with a "Notice of confirmation of transitional registration of pCm" (HKP).
During the implementation of the transitional registration arrangement, the CMB processed a total of 14 172 cases of HKP applications and approved 9 150 for issuance of HKP. Among these cases, 6 174 cases were successfully issued with HKC, while the remaining 2 976 cases were not issued with HKCs due to reasons such as the applicants' failure to submit the required information, withdrawal of applications by the applicants, or revocation of the HKPs, among others.
In view of the time taken by the trade to adapt to the registration requirements and the impact of the pandemic, the CMB extended the deadline for submission of registration information on a number of occasions. In February 2024, the CMB made a final decision that all applications for HKC from HKP must be completed by June 30, 2025. After that, HKP will be revoked for overdue cases, and the products concerned will not be allowed to be sold, imported, or possessed in Hong Kong.
Members of the public who need to verify the information of pCms can visit the CMCHK's website.
The Chairman of the CMCHK, Mrs Jeanie Hu, said, "I would like to express my heartfelt gratitude to the CMB for its efforts over the years and the full co-operation of the trade in accomplishing this historic task. The successful completion of the transitional registration for pCm signifies that all pCms currently sold in Hong Kong have strictly complied with the three core registration requirements - namely, safety, quality and efficacy - and fully met the requirements of the Ordinance in respect of packaging and labelling. This further enhances the protection of public health. The full implementation of the pCm registration system has not only raised public confidence in the regulatory system for Chinese medicines in Hong Kong, but also promoted the sustainable development of the local Chinese medicine industry, further consolidating Hong Kong's strategic position as an important hub for the internationalisation of Chinese medicines."
