FDAnews Drug Daily Bulletin

TGA Reduces Drugmaker AER Burden With New Reporting Approach

Nov. 14, 2013

Australia’s Therapeutic Goods Administration (TGA) is offering drugmakers a more streamlined approach for reporting adverse events in an effort to reduce manual data entry and the possible double handling of information.

Aussie drugmakers can now submit adverse event reports (AERs) via email using the international E2B standard, one of several electronic standards specified by the International Conference on Harmonisation. Data supplied in this format can be entered directly into the TGA’s adverse event database with minimal user interaction, the agency says.

The TGA has set up a dedicated email address, e2b.reports@tga.gov.au, for sponsors to submit AERs using the E2B format. The move is one more step in better aligning the TGA’s reporting system with other regulators such as the EU, FDA and Health Canada.

Drugmakers currently transmitting individual case safety reports electronically to other regulatory authorities use the same E2B standard being introduced by the TGA. This also offers manufacturers the potential to avoid the need to copy information into Council for International Organizations of Medical Sciences (CIOMS), the current methodology used for AERs.

CIOMS forms submitted by sponsors represent about 50 percent of the annual volume of AERs. — Nick Otto

Subscribe to Drug Industry Daily for complete coverage of the pharmaceutical industry. Click here for more information.