What is the specific process for “product registration” (commonly known as a “drug certificate”) when a new medicine is to be marketed and sold in Hong Kong?

Before any pharmaceutical product can be sold in Hong Kong, it must first be registered with the Pharmacy and Poisons Board (PPB) and issued a Hong Kong registration number (HK-XXXXX). This is a rigorous process. First, the applicant must submit a complete set of technical documents to the Drug Office, Department of Health, to demonstrate the medicine’s safety, efficacy and quality. These documents typically include pharmacological and toxicological study data, clinical trial data, the manufacturing process, quality control standards and stability test data. For medicines already registered in certain designated countries, such as the United States, the United Kingdom and EU Member States, applicants may use a simplified procedure and submit proof of registration in those countries. The Drug Office’s assessors will conduct an initial review and may request further information. Once the review is complete, the application will be submitted to the Registration Committee under the PPB for final consideration. If approved by the Committee, the medicine will be formally registered and a registration certificate issued.