Are “registrations” for proprietary Chinese medicines and Western medicines the same? How do their procedures and requirements differ?

Registration of proprietary Chinese medicines and Western medicines is intended to ensure that medicines sold in Hong Kong are safe, effective and of controlled quality. However, these are two separate, parallel systems administered by different departments, with significant differences in their procedures and requirements. Registration of Western medicines is handled by the Drug Office, Department of Health, and requires submission of a complete dossier in the internationally used Common Technical Document (CTD) format, including detailed pharmacological, toxicological and clinical study data. Registration of proprietary Chinese medicines is handled by the Chinese Medicine Regulatory Office (CMRO), with requirements that focus more on demonstrating the product’s history of use, supporting literature, and quality control of raw materials and finished products. Although safety data, such as tests for heavy metals and pesticide residues, must also be submitted, the requirements and methods for demonstrating clinical efficacy differ significantly from those for Western medicines, with greater acceptance of traditional use data and documentary evidence.