Advanced therapy products are mainly cell- or tissue-based products and gene products. Their therapeutic potential is promising but, at the same time, their complexity and rapid development also demand proper regulation. In the past 15 years, many jurisdictions started to develop regulatory regimen to properly regulate the development, production, provision and usage of advanced therapy products. In most cases, regulation of advanced therapy products is built upon the existing framework for pharmaceutical products.
Based on overseas experience, especially the regulations in the European Union, Hong Kong Government proposed a regulatory framework for advanced therapy products, which was discussed and endorsed by the Task Force on Regulation of Advanced Therapeutic Products in Hong Kong. The proposal was to classify advanced therapy products, including somatic cell therapy products, tissue engineered products and gene therapy products, as pharmaceutical products so that they are regulated under the Pharmacy and Poisons Ordinance (Cap. 138). Additional requirements on labeling, manufacturing and record keeping related to advanced therapy products are also provided.
With supports from the medical profession, pharmaceutical field, academia and general public, the proposal of amending the Pharmacy and Poisons Ordinance was introduced to the Legislative Council for scrutiny. The Amendment Bill was eventually passed in July 2020 and the Pharmacy and Poisons (Amendment) Ordinance 2020 will come into force in 2021.
Being a healthcare professional, understanding the development and regulation of advanced therapy products both in Hong Kong and overseas is important. This talk gives an overview on the global situation of advanced therapy products as well as the regulation of these products under the amended Pharmacy and Poisons Ordinance.
