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Pharmacovigilance responsibilities of medicine sponsors

Australian recommendations and requirements

27 June 2018

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Other pharmacovigilance requirements

European Union (EU) pharmacovigilance guidelines currently adopted in Australia can be found on the TGA website. We commonly reference guidance documents published by the EU where required and appropriate.

Pharmacovigilance Inspection Program

In line with other international regulators, TGA conducts inspections to assess whether sponsors are meeting their Australian pharmacovigilance regulatory obligations, including those specified in these pharmacovigilance guidelines.

The Pharmacovigilance Inspection Program (PVIP) applies to all sponsors of listed and registered medicines. For more information, please see the PVIP Guidelines.

Periodic Safety Update Reports

A Periodic Safety Update Reports (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).

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. PSURs are not required for all medicines, only those on which this specific condition is imposed. This means that we are not able to provide general advice on relevant PSUR requirements because these may vary depending on the specific conditions of registration for a particular medicine.

There is an internationally agreed format for producing a PSUR. A PSUR should present a comprehensive and critical analysis of the benefit–risk balance of a medicine and take into account new and emerging significant safety findings, in the context of cumulative information on benefits and risks.

For more information on PSURs, refer to the EMA guideline EMA/816292/2011 Rev 1* (9 December 2013) Guideline on good pharmacovigilance practices (GVP) Module VII – Periodic safety update report.

Reporting requirements for medicines supplied through an exemption scheme

When a medicine is used because access has been granted through an exemption scheme, such as the Special Access Scheme, Authorised Prescriber Scheme or Clinical Trials Scheme, different reporting requirements apply.

Special Access Scheme

The procedures for reporting adverse reactions to medicines accessed under the Special Access Scheme are outlined in Access to unapproved therapeutic goods - Special Access Scheme.

Authorised Prescriber Scheme

The procedures for reporting adverse reactions to medicines accessed under the Authorised Prescribers Scheme are outlined in Authorised Prescriber Scheme - Guidance for Medical Practitioners, Human Research Ethics Committees, Specialist Colleges and Sponsors.

Clinical trials scheme

For adverse reaction reports and significant safety issues that arise from Australian clinical trials where the medicine is used outside the approved indications or intended use, refer to Access to unapproved therapeutic goods - Clinical trials in Australia and the Note for guidance on clinical safety data management: Definitions and standards for expedited reporting.

Reporting requirements between application submission and prior to inclusion in the ARTG

In the period between the submission of a registration application and the decision to register the medicine, you are not required to routinely submit individual adverse reaction reports except when the medicines is being used in Australia in a clinical trial (in accordance with the Clinical trial guidelines).

However, during this pre-registration period, you may receive information that impacts on the benefit-risk balance from countries where the medicine is already marketed, from use in ongoing clinical trials, or from use on a compassionate basis. These may be identified as a result of ongoing review and analysis of all information. This information includes foreign reports of adverse reactions, information about the safety or benefit-risk profile of the medicine, or action taken by a foreign regulatory agency, and the basis for such action.

You are encouraged to report this as a significant safety issue to the relevant pre-marketing area of the TGA.

You should use your clinical judgement to determine what constitutes a change to the benefit-risk balance and must be reported. For example, normally another report of a well-known adverse reaction would not be considered significant, but a report of an unexpected or new serious suspected reaction with good evidence of a causal relationship, or where there is suspicion of a change in the frequency or severity of a known effect, would be considered relevant to the evaluation. Similarly, results from studies that impact on the assessment of efficacy would be considered significant. You may be required to justify a decision not to report.

For any significant safety issues for a prescription medicine with an ongoing application but not yet registered on the ARTG, notify the relevant TGA Case Manager via streamlinedsubmission@health.gov.au.

For any significant safety issues for a non-prescription medicine with an ongoing application but not yet registered or listed on the ARTG, notify otc.medicines@health.gov.au, or complementary.medicines@health.gov.au as appropriate.

Lapsed or withdrawn applications

When an application to include a medicine on the ARTG lapses or is withdrawn, the Secretary of the Department of Health may require you, under section 29B of the Act, to disclose whether you are aware of certain information mentioned in subsection 29A(2) or 29AA(2) about the medicine and, if so, to provide that information.

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