The Department of Health (DH) announced on April 28 that it will enhance support for local pharmaceutical companies to utilize the newly simplified approval process for Hong Kong-registered traditional oral Chinese proprietary medicines (CPM) entering the mainland market.
This follows a recent policy by the National Medical Products Administration (NMPA) that streamlines registration for eligible Hong Kong CPM. The NMPA's mid-January announcement applies to oral CPMs manufactured by Hong Kong companies that have been registered with the Chinese Medicine Council for 15 years or more and comply with Good Manufacturing Practice (GMP) standards. On April 28, the NMPA's Center for Drug Evaluation (CDE) provided guidelines for application requirements.
To help local enterprises understand the new process, the DH's Chinese Medicine Regulatory Office (CMRO) will hold monthly seminars for stakeholders, offer consultation services for applications, and maintain a dedicated webpage on Greater Bay Area (GBA) Chinese medicine integration. Dr. Ronald Lam, Director of Health, emphasized the policy's significance, expressing gratitude to the Central Government for expanding the approval mechanism to oral formulations, aligning with the Chief Executive's goals for GBA healthcare collaboration.
Since the streamlined process for topical CPMs began in 2021, 13 Hong Kong-registered topical medicines have entered the mainland market. There are about 8,200 registered CPMs in Hong Kong, including 5,000 oral formulations, with around 200 meeting the eligibility criteria for the mainland. The CMRO will continue to work with industry and mainland authorities to advance regulatory standards and sector growth. For more details, visit the CMRO website.
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