On 1st September 2017, the TGA published the revised edition (Version 2.0) of the ‘Pharmacovigilance responsibilities of medicine sponsors – Australian recommendations and requirements’. This guidance sets out the pharmacovigilance responsibilities of sponsors of medicines included on the Australian Register of Therapeutic Goods (ARTG) and regulated by the TGA. It outlines the mandatory reporting requirements and offers recommendations on pharmacovigilance best practice.
In addition, the TGA published the ‘Pharmacovigilance inspection program – Guidance for medicine sponsors’. This guidance is aimed at helping sponsors understand the TGA’s pharmacovigilance inspection program (PVIP). It outlines how they prepare, conduct, report and follow up pharmacovigilance inspections and lists the criteria used when scheduling inspections.
TGA have advised that inspections will take place from the beginning of 2018. Sponsors will be given six to eight weeks’ notice in writing, prior to an inspection taking place.