Hong Kong Drug Office updated Guidance for Adverse Drug Reaction Reporting Requirements to include special considerations for advanced therapy products in section 6, to be effective from 1 August 2021.
Due to their novelty, complexity and technical specificity, ATPs may raise some new and unexplored risks and safety concerns which require special attention. Reporting of adverse drug reactions and monitoring of such reports could facilitate early detection and management of the safety signal.
The guidance listed some potential adverse drug reactions of concern. The list serves to provide examples to stimulate further considerations.
To enable traceability of adverse drug reaction reports to the product, reports which do not contain the batch number of the ATP used should be followed up to obtain such information. Batch number should be included in the report to Drug Office.
For ATPs, pharmaceutical industry should ensure that database or other record system capable of linking the adverse drug reaction reports with other traceability data is in place. Such linkage could be established via the batch number of the ATPs used or other traceable data.
More details in Guidance for Pharmaceutical Industry - Adverse Drug Reaction Reporting Requirements Version 1.0: