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Pharmacovigilance Update

The industry has three main objectives for pharmacovigilance:

  • to minimise risk for patients and sponsors;
  • to meet global regulatory reporting requirements; and
  • to manage risks relating to a drug over its life cycle.

The TGA has made changes in the past year to strengthen pharmacovigilance. The Advisory Committee on the Safety of Medicines (ACSOM) was formed in January to advise and make recommendations to the TGA on the safety of medicines, risk assessment and risk management of medicines.

ACSOM supersedes the Adverse Drug Reactions Advisory Committee (ADRAC) and expands upon its role. The new organisation has an increased focus on the safety aspects of medicine regulation, as well as the detection, assessment, understanding and prevention of adverse effects.

Risks and life cycles

Risk management plans are designed to define and pro-actively manage risks relating to medicines over their life cycles. It is one of ACSOM’s major roles to provide advice on the quality and appropriateness of these plans.

In February, the TGA decided that Periodic Safety Update Reports (PSURs) for well-established active substances and generics need only be submitted upon request. (There were no changes to PSUR requirements for new drugs).

Sponsors were sent a letter varying their specific condition of registration for PSURs. This variation stipulated that they should continue to prepare but not submit a PSUR unless requested by the TGA. (Sponsors will have 10 days to comply with any TGA requests.)

The following requirements have not changed:

  • Foreign reports need not be forwarded to the TGA routinely, but instead in the context of a specific safety issue or upon specific request.
  • Where the adverse drug reaction (ADR) has occurred in Australia, literature reports must still be submitted. These can be a challenge for generic drugs because each sponsor of the drug (even where there are multiple sponsors) must meet the usual PV timelines and obligations. This can lead to multiple reporting of the same literature by different drug sponsors.
  • All sponsors must still forward Australian ADR reports to the Office of Medicines Safety Monitoring (OMSM) in various formats depending on drug status, type of ADR report, and whether the ADR is serious. The OMSM has a preferred ‘Blue Card’ format for the presentation of clinical details concerning ADRs. The OMSM will, however, also accept reports in CIOMS1 format.
  • ADRs can be reported electronically via the TGA website or via email or fax.

Required formats and timeframes are listed below:

Drug Status Format Timeframe
Spontaneous report
Serious Blue card < 15 days
Other Line listing in PSUR
Company-sponsored post-marketing surveillance study
Serious Blue card < 15 days
Other Tabulation At end of study
Spontaneous report
Serious Blue card < 15 days
Other Tabulation Regularly

The TGA officially launched a new organisational structure on 1 July 2010.  Post marketing safety functions for all types of therapeutic products are managed by the Office of Product Review, which is part of the Monitoring and Compliance Group.

The main contact points for reporting suspected reactions to medicines are unchanged, and information for health professionals and consumers – such as alerts, advisories and Medicines Safety Update – will continue to be published as usual.

The Commercial Eyes Medical Services Team provides Australia’s largest and most comprehensive medical information and pharmacovigilance service. Our call centre is staffed by industry experienced pharmacists, using state-of-the-art telecommunications and enquiry database systems. Please contact us if you would like any further information on this topic or to discuss your pharmacovigilance needs.

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