The ISSCR Shared Comments on Hong Kong’s Draft Guidance for Cell and Tissue Products
31 December 2021
The ISSCR condemns the premature commercialization of unproven cell therapies, which has resulted in patients being blinded, paralyzed, and infected with dangerous pathogens. In many countries, unscrupulous businesses marketing these unproven cell therapies have abused ambiguous definitions for substantial/minimal manipulation and homologous use to claim they are not subject to oversight. Regulators around the world need to adopt harmonized product definitions to protect public health and to prevent the premature commercialization of stem cell-based products.
We appreciate that Hong Kong enacted the “Pharmacy and Poisons (Amendment) Ordinance 2020” because it broadly defined stem cell-based interventions as Advanced Therapy Products—requiring well-regulated clinical trials to demonstrate safety and efficacy prior to marketing. However, we are concerned that the definition of substantial manipulation and homologous use in the 2020 ordinance and the draft Guidelines for Cell and Tissue Products is too ambiguous and may be abused. We encourage you to include examples in the guidance to clearly explain the definition for substantial manipulation and homologous use since they are pivotal to delineate whether products are regulated as advanced therapies.