Quote from VigiServe Admin on November 24, 2020, 2:57 PM

The TGA applies a risk management approach to ensuring that medicines included on the Australian Register of Therapeutic Goods (ARTG) meet acceptable standards of quality, safety and efficacy, and are subject to ongoing monitoring to ensure that these standards are maintained.

Inspections assess the appropriateness and compliance of your pharmacovigilance system in line with the Pharmacovigilance guidelines. At a minimum (for routine inspections), the TGA will review the following aspects of your system during an inspection:

• the collection, collation, processing, timely and appropriate reporting and follow-up of adverse reaction reports

• where relevant, the preparation of Periodic Safety Update Reports (PSURs) and your adherence to risk management plans (RMPs)

• the ongoing analysis of the benefit-risk profile of your medicine(s) during the post-authorisation period, including analysis of global data where relevant

• the reporting of significant safety issues

• how you maintain any reference safety information to ensure product information is up-to-date and in line with current scientific knowledge

• whether your qualified person responsible for pharmacovigilance in Australia (QPPVA) is suitable and available, and what activities they undertake

• whether there are appropriate safety agreements in place and being adhered to with any company contracted to perform pharmacovigilance activities on your behalf

• clinical trials involving medicines on the ARTG where the medicine is used in line with the product information or label indications.