The Pharmacy and Poisons Board of Hong Kong (PPBHK) today (January 4) announced that it had become the 47th Participating Authority of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) with effect from January 1, 2016.
The PIC/S is an international organisation comprising pharmaceutical inspection authorities around the world with a mission to lead the international development, implementation and maintenance of harmonised Good Manufacturing Practice (GMP) standards and quality systems of inspectorates in the field of medicinal products. As of January 1, 2016, there were 48 participating authorities in the PIC/S.
In Hong Kong, all pharmaceutical manufacturers must obtain a licence from the PPBHK to produce medicines. One of the key requirements for licensing a pharmaceutical manufacturer is the full compliance of the PIC/S GMP standards. The Drug Office of the Department of Health (DH) provides licensure support to the PPBHK and conducts GMP inspections to ensure compliance.
The PPBHK considered that its accession to the PIC/S signified the recognition of its GMP inspectorate and the pharmaceutical trade by international drug regulatory authorities. The PPBHK is confident that medicines produced in Hong Kong are on par with international standards.
In 2009, the former Review Committee on Regulation of Pharmaceutical Products in Hong Kong recommended the DH to upgrade the licensing standards of local drug manufacturers to the PIC/S GMP standards. GMP is a quality assurance approach used by the drug manufacturing industry to ensure that products are consistently produced and controlled throughout the manufacturing process. In the past few years, both the Drug Office of the DH and local pharmaceutical manufacturers have been putting tremendous efforts to attain a higher GMP standard. Subsequently, the PPBHK has adopted the PIC/S GMP as one of the licensing conditions for local manufacturers with effect from October 1, 2015.
Following the PPBHK's application for accession to the PIC/S, an audit team established by the PIC/S visited Hong Kong in January 2015 to evaluate the drug regulatory system and GMP inspection standard of Hong Kong. The PIC/S then considered that the regulatory standards of Hong Kong complied with its requirements and accepted the PPBHK as the 47th Participating Authority with effect from January 1, 2016.