Pharmacovigilance Inspection Program

1 September 2017

Following a successful pilot program conducted in 2015-16, the TGA's Pharmacovigilance Inspection Program (PVIP) has been implemented as an initiative to help sponsors of medicines to meet their pharmacovigilance obligations.

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.

Pharmacovigilance is defined by the World Health Organization as the science and activity related to detecting, assessing, understanding and preventing adverse effects and other medicine-related problems.

The aim of therapeutic product vigilance is to continually monitor and evaluate the safety and efficacy (performance) profile of therapeutic products and to manage any risks associated with individual products.

Sponsors have the primary responsibility for the safety of any therapeutic products they import, supply or export from Australia, and there are penalties for not meeting these obligations.

The PVIP is a product vigilance program designed to facilitate the collection and evaluation of safety information relating to all medicines on the ARTG. It involves TGA representatives interviewing sponsors and reviewing documents in order to assess the sponsor's compliance with pharmacovigilance requirements set out in:

Further information on the inspection process can be found in the PVIP Inspection guidelines.

Inspections benefit sponsors by identifying areas within their existing pharmacovigilance practices where there may be gaps or where improvements could be made. This will help them to improve their pharmacovigilance systems and quality processes as a whole – ultimately ensuring the ongoing safety of medicines available to the Australian public.

Further information about Australia's therapeutic product vigilance system is available on the TGA website.

PVIP information sessions

From September 2017, the TGA will be holding PVIP information sessions for sponsors in Sydney, Brisbane and Melbourne. The presentation will be available to review here on completion of the information sessions. For further information about these events, visit the TGA's events and training web page.

Questions and answers

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The PVIP will assist the TGA to strengthen and broaden its post-market monitoring activities by:

  • educating sponsors on their pharmacovigilance requirements
  • working with sponsors to ensure pharmacovigilance systems are collecting current information on the safety and efficacy of their medicines
  • verifying Australian sponsors' compliance with existing pharmacovigilance requirements.

Information on the PVIP will be published on the TGA website and distributed to sponsors.

Sponsors will be provided with the PVIP Inspection Guidelines and the revised Pharmacovigilance Guidelines.

Sponsors will have the opportunity to ask questions at the PVIP information sessions and/or via email (see the 'Contacts' section below).

Inspections will commence after the PVIP information sessions have been completed and sponsors have received the PVIP Inspection Guidelines and the revised Pharmacovigilance Guidelines.

Sponsors will be given six to eight weeks' notice prior to an inspection taking place.

Sponsors will be notified six to eight weeks prior to the inspection.

The announcement of the inspection will be in writing and may include, for example, the objectives, nature/type of the inspection, the dates and if known the address of the proposed inspection site(s).

In exceptional circumstances, an inspection may be performed without prior notice.

The schedule for Australian pharmacovigilance inspections, including the prioritisation of reinspection, will be risk-based.

Early re-inspection may take place where significant non-compliance has been identified.

Inspection guidelines are based on the UK Medicines and Healthcare products Regulatory Agency (MHRA) guidelines, but also address relevant Australian issues and requirements.

The TGA will publish de-identified six-monthly statistics, commencing 12 months after the first inspection, on the number of inspections held, type of inspections, type of findings and whether they have been resolved.

A summary of conclusions based on this data may be included, particularly in relation to comparisons over time.

Resources

Any TGA presentations relating to pharmacovigilance and the PVIP made in the past 12 months can be found on the TGA's presentations web page.

Contacts

For any PVIP-related enquiries, please email Pharmacovigilance.Inspections@health.gov.au.