In June 2021, The Pharmacy and Poisons Board of Hong Kong issued 5 new guidances for Advanced Therapy Products. These guidances will be effective in August 2021.
Guidance on Classification of Advanced Therapy Products
The aim of this document is to provide guidance on the advanced therapy product (ATP) classification and on the interpretation of key concepts of the definitions of gene therapy product (GTP), somatic cell therapy product (SCTP) and tissue engineered product (TEP).
Guidance on Application of Certificate of Drug/Product Registration — Advanced Therapy Products
This guidance outlines the procedures and requirements for the application of the Certificate of Drug/Product Registration (the “Registration Certificate”) for ATP. The technical requirements for The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Common Technical Document (CTD) Modules 3 to 5 for pharmaceutical products apply to registration of ATP.
This guidance also describes the specific requirements for these modules for registration of ATP.
- Guidance on Labelling Requirements of Product Code, Unique Donation Identifier and Unique Recipient Identifier for Advanced Therapy Products
This guidance aims to provide information to licensed manufacturers and licensed wholesale dealers on the requirements of assigning the Product Code, Unique Donation Identifier and Unique Recipient Identifier for labelling of ATPs stated under regulation 31(1)(g)(i) and (ii) of the PPR. It also introduces two internationally recognized labelling systems – the ISBT 128 standard and the Single European Code, that could be adopted for assigning the Product Code and Unique Donation Identifier for ATPs containing or consisting of human cells or tissues.
Guidance on Record Keeping for Licensed Manufacturers and Licensed Wholesale Dealers – Advanced Therapy Products
This guidance outlines the requirements for handling the following records required by the Pharmacy and Poisons Regulations, Cap. 138A (PPR) in relation to Advanced Therapy Products (ATPs)–
- Records stipulated in regulation 35(1) of the PPR (the “Regulation 35(1) Records”), applicable to licensed manufacturers
- Transaction record stipulated in regulation 28(1) & (2) of the PPR (the “Transaction Record”), applicable to both licensed manufacturers and licensed wholesale dealers
Guidance on Application of Certificate for Clinical Trial – Advanced Therapy Products
This guidance outlines the requirements and procedures for the application of certificate for clinical trial of ATP. In addition, this guidance also highlights some special considerations for selected documents required for application of certificate for clinical trial of ATP.