Regulation of Advanced Therapy Products

The Pharmacy and Poisons Board of Hong Kong has endorsed a set of Guidance Documents and new edition of the Codes of Practice for licensed traders with reference to the enhanced regulatory control of Advanced Therapy Products (“ATPs”). The abovesaid Guidance Documents and Codes of Practice has taken effect on 1 August 2021, soft copies of the documents are available at the following links:

Guidance Documents:
(effective from 1 August 2021 onwards)

Guidance for Pharmaceutical Industry – Adverse Drug Reaction Reporting Requirements

Guidance on Application of Certificate for Clinical Trial – Advanced Therapy Products

Guidance on Application of Certificate of Drug/ Product Registration – Advanced Therapy Products

Guidance on Record Keeping for Licensed Manufacturers and Licensed Wholesale Dealers – Advanced Therapy Products

Guidance on Labelling Requirements of Product Code, Unique Donation Identifier and Unique Recipient Identifier for Advanced Therapy Products

Guidance on Classification of Advanced Therapy Products

New Edition of Codes of Practice:
(effective from 1 August 2021 onwards)

Code of Practice for Licensed Manufacturers and Registered Authorized Persons

Code of Practice for Holder of Wholesale Dealer Licence

Code of Practice for Authorized Seller of Poisons

Code of Practice for Listed Seller of Poisons

For more information about the regulation of ATPs, please contact the Drug Office of the Department of Health at 2961-8599 or visit their website at
https://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/atp_regulation.html.