Does Hong Kong accept Mainland China NMPA approval outcomes for pharmaceutical product registration?

At present, Hong Kong’s pharmaceutical product registration system simplifies procedures mainly by recognising approval decisions made by the regulatory authorities of certain designated “reference countries”. These include the United States, the United Kingdom, EU Member States, Australia, Canada and Japan. If a medicine has obtained marketing authorisation from at least two authorities in these countries, its application for registration in Hong Kong may benefit from a degree of simplification. However, to date, China’s National Medical Products Administration (NMPA) has not been formally designated as a “reference authority” for Hong Kong medicine registration. This means that even if a medicine has been approved by the NMPA for marketing in mainland China, a full set of technical documents must still be submitted for a comprehensive assessment by the Department of Health when applying for registration in Hong Kong; the simplified procedure is not available. However, as integration within the Greater Bay Area deepens, communication and mutual recognition between the regulatory authorities on both sides are strengthening, and policy may develop in future.