Government launches public consultation on regulation of advanced therapy products

     The Government today (April 3) launched a two-month public consultation to seek views on the regulation of advanced therapy products (ATPs) which are derived from tissues and cells for administration to patients for therapeutic purposes.
     A spokesman for the Department of Health said, "Given the recent fast development of ATPs, information on their effectiveness and long-term side effects is limited. To safeguard public health, the Government proposes to put ATPs under the existing regulatory framework for pharmaceutical products, which requires the amendment of the Pharmacy and Poisons Ordinance (Cap. 138)(PPO)."
     The consultation document sets out the Government's proposal to include the definitions of ATPs under the definition of pharmaceutical products in the PPO. Other amendments include the addition of new requirements on licensing of manufacturers, labelling and record keeping.
     Members of the public and relevant stakeholders are welcome to provide their views on the proposed regulation of ATPs and the amendments to the PPO as set out in the consultation document. Views can be sent by email (, by fax (2834 5117) or by post to the Drug Office, Department of Health, Room 1856, 18/F, Wu Chung House, 213 Queen's Road East, Wan Chai, Hong Kong, on or before June 2, 2018.
     For further information about the consultation and access to the consultation document, please visit the website at

Ends/Tuesday, April 3, 2018
Issued at HKT 15:00