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Risk management plans for medicines and biologicals
Australian requirements and recommendations
Periodic Safety Update Reports
A Periodic Safety Update Report (PSUR) is a systematic review of the global safety data of an approved medicine that becomes available to you during a defined time period. PSURs are also referred to as Periodic Benefit–Risk Evaluation Reports (PBRERs).
We will apply the requirement to submit PSURs as a condition of registration.
We will recommend a condition of registration requiring PSURs in the round 2 RMP evaluation report. You should raise any practical issues in relation to the provision of PSURs to avoid the need for varying the condition after registration.
PSURs are required for certain registered medicines. The requirement to submit PSURs can be applied as a condition of registration under section 28(2B) of the Act when the medicine is included on the ARTG.
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The TGA has adopted the EU PSUR guidelines with annotations:
- EMA/816292 (pdf,1.44Mb) Guideline on good pharmacovigilance practices (GVP) Module VII - Periodic safety update report
You should also refer to Pharmacovigilance responsibilities of medicine sponsors for information about content to include in PSURs.
Where we have identified additional safety concerns and these have been included in the ASA, ensure you report these in an attachment to the PSUR.
When PSURs are required
We take a risk-based approach to determining if PSURs should be submitted to the TGA, and the frequency and duration of submission. Factors we consider when determining the appropriate PSUR condition of registration include:
- the availability of safety information about the product
- the nature of the safety concerns associated with the product and their impact on public health
- the potential implications of any changes to the product for the safety profile of the product or availability of information about the safety profile
- whether populations described in missing information (such as children and pregnant women) are likely to use the product after registration
- whether there are safety concerns specific to Australia
We will usually require sponsors to submit PSURs at least annually until the submitted PSURs cover a period of not less than 3 years from the date of approval for:
- new chemical and biological entities,
- extensions of indication and
- major variations,
assessed under the standard or priority registration pathways. After the end of the initial 3-year period we may request submission of additional PSURs if we determine that close monitoring of a product's safety should continue.
For lower-risk extensions of indication and major variations we may request that PSURs be prepared but submitted only when we request them.
For provisionally registered medicines, we will usually require sponsors to submit PSURs regularly for a longer period than the standard 3 years, to account for the provisional registration period, which may last up to 6 years. We may require PSURs for provisionally registered products to be submitted more frequently, for example 6-monthly.
Determining the PSUR condition of registration
For applications for which we evaluate an RMP, we will include a recommendation to the Delegate for a condition of registration requiring PSURs in the round 2 RMP evaluation report. You should raise any practical issues in relation to the provision of PSURs (such as the availability of complete PSURs in the required timeframes) in your response to the round 2 RMP evaluation report to avoid the need for varying the condition after registration.
For products that are approved in the European Union, we will align the reporting requirements and timeframes with those required by the EMA where possible and appropriate.
A PSUR submission does not require a minor variation request or notification.
How to submit a PSUR
You should submit your PSUR as an eCTD/NeeS sequence, as a standalone sequence with sequence type 'periodic safety update report'.