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.
In the draft legislation shared this week, the government defines ATPs and proposes treating them as a subset of pharmaceutical products. The planned approach means ATPs will be subject to the same requirements as other pharmaceuticals, plus certain rules specific to the modality.
The government plans to make all facilities that produce ATPs obtain a license and comply with good manufacturing practices. Exactly what that means for organizations that make ATPs, which include small sites such as hospitals, will become clearer when the Department of Health provides codes of practice for the industry.
Other sections of the bill state manufacturers of ATPs must provide unique donation identifiers and product codes on their packaging, as well as information found on other pharmaceutical products.
The Legislative Council is due to start reviewing the bill toward the end of the month.
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