PIC/S GMP refers to Good Manufacturing Practice (GMP) established by the Pharmaceutical Inspection Co-operation Scheme (PIC/S). PIC/S is an international organisation of medicines regulatory authorities, intended to harmonise GMP standards and inspection procedures. The Department of Health in Hong Kong is a PIC/S member. This means that the standards used in Hong Kong to assess and issue a manufacturer's licence (GMP) are fully aligned with international PIC/S standards. Any company wishing to manufacture medicines in Hong Kong must ensure that its manufacturing facilities, quality management system, production processes and personnel qualifications fully meet the stringent PIC/S GMP requirements. By adopting the highest international standards, Hong Kong ensures that locally manufactured medicines can meet international quality standards and be recognised by other PIC/S members, such as EU countries, Australia and Canada, paving the way for exports.
HONG KONG DRUG LICENSING
What is PIC/S GMP? How does it relate to a pharmaceutical product manufacturer licence in Hong Kong?
A complete explanation of the regulatory basis, Drew Tang’s recommendations and risk alerts. The original material dates from 2025; read it alongside the latest official requirements.
Original guide, 2025 edition: These FAQs are provided for topic-based reference and have not all been individually checked against current rules. Please confirm fees, personnel, renewal, changes and product requirements against the professional in-depth guide for the relevant licence type and the official requirements in force at the time.
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