China – Hong Kong Proposes Regulatory Framework for Cell and Gene Therapies

Hong Kong has proposed legislation to create a regulatory framework for advanced therapy products (ATPs), such as interventions based on cells, genes and tissues. The plan is to amend existing laws to create licensing, labeling and record-keeping requirements for ATPs.

Work to update the law in Hong Kong in light of the rise of ATPs began last year with a consultation. The government took the steps in the belief that “the high risks associated with the rapid scientific advancement” of ATPs means a dedicated regulatory framework is needed to protect public health and support innovation. Differences between production of ATPs and other drugs were also factors…