Improving Access to Medicine Adverse Event Data

The Australian Therapeutic Goods Administration (TGA) sought consultation from its sponsors on enhancing their access to medicine adverse event data to support their pharmacovigilance obligations. The feedback will allow the TGA to implement a better way of improving the management of medicine safety signals.

?To let the sponsors view and export relevant de-identified medicine adverse event data from the systems using the existing authentication process, TGA sought feedback on:

·?What drug adverse event information do sponsors wish to view and/or extract from TGA’s Adverse Events Management System (AEMS).

·?The prescribed format(s) for the extracted data to support its upload into sponsor pharmacovigilance systems.

·??Sponsors’ ability to transition to use the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Enterprise to Business (E2B) R3 standard for submitting and obtaining adverse event reports via the secure Electronic Data Interchange (EDI) service.

The survey was open until February 18, 2022.

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