TGA streamlines adverse event reporting

AusBiotech has welcomed the TGA’s announcement that it has introduced a streamlined way for sponsors to submit adverse event reports for medicines and vaccines, to ease the administrative burden of the 7000-8000 annual reports.

The TGA says the streamlining will make it easier to meet mandatory reporting requirements and reduce manual data entry and double handling, as well as the potential for errors.

Sponsors will now be able to submit adverse event reports via email to e2b.reports@tga.gov.au using the widely used international ‘E2B’ standard. Data supplied in this format can be entered directly into the TGA’s adverse event database with minimal user interaction.

Dr Anna Lavelle, CEO of AusBiotech, said, “The TGA’s newly introduced streamlined process for adverse event reporting on medicines and vaccines will help reduce compliance burden and align the Australian TGA system with equivalent regulatory bodies in Europe, the USA, Japan and Canada.

“The move is most welcome by Australian life science companies. It is encouraging to see Professor John Skerritt, as the head of the TGA, leading a team to cut out regulatory steps and increasing efficiencies.”

The TGA said it is continuing to work towards removing barriers to information exchange relating to adverse event reporting.