Changes to submission of ADR reports for unapproved medicines and biologicals

7 April 2017

The TGA has updated its processes for receiving suspected unexpected serious adverse reaction (SUSAR) reports for medicines and biologicals used in clinical trials under the Clinical Trials Notification (CTN) or Clinical Trials exemption (CTX) schemes.

If you need to submit an SUSAR report for a clinical trial, you can do so through the TGA Business Services (TBS) ADR submission portal or by email using a Blue Card or CIOMS form to adr.reports@tga.gov.au.

E2B reports should be emailed to e2b.reports@tga.gov.au.

Serious adverse reactions relating to medicines accessed through the Special Access Scheme and Authorised Prescriber Scheme can also be submitted through the TGA Business Services (TBS) ADR submission portal or by email using a Blue Card or CIOMS form to adr.reports@tga.gov.au.

For additional information, refer to the appropriate guidance documents.

For further information, email adr.reports@tga.gov.au or call 1800 010 624 (freecall within Australia).

Summary table of pharmacovigilance reporting requirements for medicine sponsors*
Report type Method/format of reporting Reporting timeframe
Serious adverse reaction reports Blue card/CIOMS form/E2B reports (e2b.reports@tga.gov.au)/online reporting form < 15 calendar days
Serious adverse reactions relating to the Special Access Scheme and Authorised Prescriber Scheme** Blue card/CIOMS form/E2B reports (e2b.reports@tga.gov.au)/online reporting form

< 15 calendar days

For fatal or life-threatening ADRs, send initial report within 7 calendar days of first knowledge. Follow up with complete report within 8 additional calendar days.

Serious unexpected suspected adverse reactions relating to clinical trials*** Blue card/CIOMS form/E2B reports (e2b.reports@tga.gov.au)/online reporting form

< 15 calendar days

For fatal or life-threatening ADRs, send initial report within 7 calendar days of first knowledge. Follow up with complete report within 8 additional calendar days.

Significant safety issues In writing to the Pharmacovigilance and Special Access Branch, preferably via facsimile or email < 72 hours
Non-serious adverse reaction reports As line listings or in requested format If requested by the TGA, within the requested timeframe, or in Periodic Safety Update Report (PSUR) if one is required

* For more information please refer to the pharmacovigilance document.

** For further information please refer to Access to unapproved therapeutic goods via the Special Access Scheme.

*** For further information please refer to clinical trials.