What is distinctive about Hong Kong's pharmaceutical licensing system compared with those of other countries or regions?

Hong Kong’s pharmaceutical licensing system is known internationally for its rigour and efficiency. Its distinctive features include the following. First, it operates within an “English-style” common law system, where case law and legislation are both important. Regulatory authorities have a degree of discretion in enforcement, but the overall framework is clear and transparent. Second, Hong Kong operates a dual system of “medicine registration” and “business licensing”. A medicine must first obtain product registration to demonstrate that it is safe, effective and of acceptable quality; only then can a company holding the relevant business licence, such as a wholesale dealer licence, handle it. Third, Hong Kong is a major international hub for pharmaceutical procurement and re-export. Its regulatory system is closely aligned with international standards such as PIC/S Good Manufacturing Practice (GMP), and is recognised by many countries. Medicines registered and companies licensed in Hong Kong therefore often enjoy certain advantages when entering other markets. Fourth, systematic statutory regulation of Chinese medicine is a distinctive feature and is relatively advanced globally. Overall, Hong Kong’s system strikes a good balance between protecting public health and promoting the development of the pharmaceutical industry.