Implementation of GDP for Pharmaceutical Products in Hong Kong

The Pharmacy and Poisons Board of Hong Kong has launched a public consultation on implementing Good Distribution Practice (GDP) for pharmaceutical products in Hong Kong by adopting the PIC/S Guide to Good Distribution Practice.

The proposal aims to strengthen supply chain integrity, align Hong Kong’s regulatory approach with internationally recognised standards and practices, and ensure that medicines are consistently stored, handled and transported under suitable conditions throughout distribution.

The following draft documents were published on the website of the Drug Office of the Department of Health:

• Guide to Good Distribution Practice for Pharmaceutical Products (“GDP Guide”)
• Guidance for Industry: Guide to Good Distribution Practice for Pharmaceutical Products (“Guidance for Industry”)
• Revised Code of Practice for Holder of Wholesale Dealer Licence (“WDL COP”)

According to the consultation documents, GDP would be introduced via additional application requirements and/or licensing conditions for licensed manufacturers and wholesale dealers. Implementation is planned to start with new applicants in Q3 2026 and extend to relevant existing licensees in Q3 2028.

The consultation period runs from 1 April to 31 May 2026. Please also see the Consultation Document for further information.