The TGA commenced its Pharmacovigilance Inspection Program (PVIP) in 1 September 2017.
Pharmacovigilance refers to the monitoring and prevention of the adverse effects of medicines, after they have been approved for use. All sponsors are legally responsible for meeting pharmacovigilance reporting requirements for all medicines listed on the Australian Register of Therapeutic Goods (ARTG), regardless of their marketing status – that is, whether they are currently available for purchase, withdrawn from sale or otherwise.
It is expected that a PV system be put in place by each sponsor, to ensure the acquisition of sufficient information for the scientific evaluation of adverse reactions and suspected adverse reaction reports.
The Pharmacovigilance Inspection Program (PVIP), developed in line with other international regulators, is a program whereby the TGA will conduct inspections, to assess whether sponsors are meeting their Australian pharmacovigilance regulatory obligations, which will be specified in the revised Pharmacovigilance Inspection Program Guidelines and Pharmacovigilance Guidelines once the results of the consultation on those guidelines have been reviewed.
As part of your responsibility as a sponsor you are required to adequately record all adverse events and report all adverse reactions (AR) to a product in a specified time frame and based on the requirements of the proposed Guidelines pertaining to content requirements and how reports must be submitted. In addition to these obligations, sponsors are required to comply with other reporting requirements which include reporting a contact person to the TGA and reporting other significant safety issues that may be found in local and international media or literature as well as having adequate SOP’s and staff training to ensure that the requirements for pharmacovigilance are adequately managed.
To assist in implementing systems and compliance with the requirements for Pharmacovigilance, Advanced Wellness Regulatory Solutions have created a Pharmacovigilance package and training program for sponsors and their nominated pharmacovigilance staff. Any sponsor who does not have a Pharmacovigilance system in place and is interested in learning more, please email us at info@regsolutions.com.au
