The ISSCR Shared Comments on Hong Kong's Draft Guidance for Cell and Tissue Products

The ISSCR recently offered comments on the draft Guidance for Cell and Tissue Products (those not classified as Advanced Therapy Products) with Assistant Director Frank Chan, Drug Office, Department of Health, Hong Kong.

In the comments, the ISSCR condemns the premature commercialization of unproven cell therapies, which has resulted in patients being blinded, paralyzed, and infected with dangerous pathogens and stresses that 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.

The letter states, among other things, that the ISSCR appreciates 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, it makes clear that the Society is 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.

Read the letter.