New Hong Kong ordinance to regulate advanced therapy products

Advanced Therapy Products (ATPs) will be subject to tighter regulation in Hong Kong under an ordinance passed by the legislative council of the special administrative region of China. The ordinance, expected to go into effect next year, requires facilities to obtain a license to manufacture ATPs, and adhere to specific labeling requirements specifying clear identification of each unit sold or distributed. The ordinance also requires manufacturers and licensed wholesale dealers of ATPs to maintain photographs of product specifications and, in a mandate that industry representatives call onerous, maintain sales records for 30 years.