The Therapeutic Goods Administration (TGA) is initiating a pilot pharmacovigilance inspection program this year and is currently requesting a variety of pharmaceutical industry volunteers to help shape the program.
The pilot inspection program will assess companies’ pharmacovigilance system compliance with current Australian legislation and guidelines. Importantly the pilot program will be used to assess the processes utilised by the TGA for the inspections and will inform any future inspection program in the Australian context.
The pilot seeks to understand the broad variations in pharmacovigilance systems currently in place in Australia, throughout the spectrum from small companies to multinational companies and encompass sponsors of complementary, over the counter and prescription medicines. The TGA in particular seeks sponsors with a diverse range of products and those with multiple product lines in particular to volunteer.
An inspection as part of this pilot program will involve interviews with staff members and the TGA reviewing documents in order to assess the company’s pharmacovigilance system compliance with applicable Australian legislation and guidelines.
The inspection is likely to be an onsite but aspects may be done via teleconference/videoconference if required. The inspectors will feed back any non-compliance determined during the inspection as findings at the end of the inspection and subsequently in an inspection report issued to the company.
The TGA says it is hoped that this pilot will be beneficial to sponsors in highlighting areas within their existing pharmacovigilance practices where there may be gaps and therefore improving systems and quality processes as a whole.
There is no fee associated with inspections during this pilot and inspection dates will be scheduled according to mutual availability. It will be requested that all participating sponsors provide feedback after the inspection on the process; a questionnaire to procure such feedback will be supplied. It is not expected that the inspection process will be onerous on staff members involved and the TGA says it will aim to minimise work disturbances. In addition, recognition for an inspection performed during the pilot will be made in any future inspection program.
Interested sponsors should register by contacting Sarah May on (02) 6232 8753 or sarah.may@tga.gov.au by the 1st July 2015