In Hong Kong, New Ordinance Regulating Use of Advanced Therapy Products (ATPs) Goes into Effect

Regulations governing the use of Advanced Therapy Products (ATPs) went into force in Hong Kong in August, codifying an ordinance passed last year by the legislative council of the special administrative region of China that subjects the products to tighter regulation.

The regulations classify ATPs—which encompass advanced gene therapy, somatic cell therapy and tissue-engineered products, often involving the substantial manipulation and alteration of cells or tissues—as pharmaceuticals. They require facilities obtain a license to manufacture ATPs, and adhere to specific labeling requirements specifying clear identification and tracing capabilities of each unit sold or distributed.

The ordinance also requires manufacturers and licensed wholesale dealers of ATPs to maintain photographs of product specifications and to maintain sales records for years.