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Pharmacovigilance inspection program: Guidance for medicine sponsors

Version 1.0, September 2017

1 September 2017

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Publishing pharmacovigilance inspection data

Reported information

We publish de-identified information on completed pharmacovigilance inspections on the pharmacovigilance inspections TGA web page; the information published will not identify individual medicine sponsor names. However, if an inspection leads to regulatory actions being taken under the Act, this information will be published in line with TGA compliance and enforcement procedures, which can include identification of the sponsor and offences for more serious contraventions of the Act and/or Regulations. The de-identified inspection information published on the PVIP pages of the TGA website may include, but is not limited to:

  • the number of inspections conducted in the previous 12 months and how many were scheduled as part of the risk-based approach or were for cause inspections
  • aggregate information on
    • critical findings and whether they have been resolved
    • major findings and whether they have been resolved
    • other findings and whether they have been resolved

We may include a short summary of conclusions based on the information above, particularly comparisons over time.

Reporting frequency

We expect to publish a report on our website approximately every 12 months, commencing 12 months after the implementation of our Pharmacovigilance Inspection Program.

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