Pharmacy Daily | Adverse events reporting

The Therapeutic Goods Administration has introduced a streamlined reporting system for sponsors of drugs to report adverse events to meet mandatory reporting requirements. The TGA said the new procedures will reduce manual data entry and double-handling, with reporting able to be submitted by email to e2b.reports@tga.gov.au using the widely used international E2B standard. This format enables direct entry into the TGA’s adverse event database with minimal user interaction, aligning the TGA’s process with those of its counterparts in Europe USA, Japan and Canada. Most sponsors who currently transmit Individual Case Safety Reports (ICSRs) electronically to regulatory authorities around the world use the same E2B standard. The TGA will benefit by reducing the manual data entry of forms currently submitted by sponsors, also significantly cutting the potential for errors. Currently these forms represent about 50% (7,000-8,000) of the annual volume of adverse event reports received by the TGA. A new pharmacovigilance document has been prepared to reflect these changes and can be accessed by CLICKING HERE.

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