11 Aug 2010

New arrivals - Some insights into the TGA's risk management approach

by Alexandra Rose, Josephine Hayllar

The changes increase the transparency of the TGA's decision-making processes.

Two recent changes which stem from the Therapeutic Goods Administration's Business Process Reforms illustrate the TGA's evolving approach to the regulation of prescription medicines in Australia. They are the introduction of:

  • The Advisory Committee on the Safety of Medicines (ACSOM), a statutory committee which was established to take over and expand the role of the Adverse Drug Reactions Advisory Committee (ADRAC); and
  • Australian Public Assessment Reports (AusPARs), a publicly available report produced by the TGA which contains information concerning the TGA's evaluation of a specific prescription medicine.

These changes signal an increased focus by the regulator on safety. This push is consistent with the global trend of increased monitoring of the safety of prescription medicines, especially at a post-marketing stage. They also provide some recognition of the importance of providing an increased level of transparency of the TGA's decision-making processes.

A brief outline of each of these initiatives and the role that they play will help put these reforms in context.

Advisory Committee on the Safety of Medicines (ACSOM): Role and legislative basis

ACSOM is a statutory expert committee, established under the Therapeutic Goods Regulations, to take over and expand on the role of the ADRAC. ACSOM's powers are broader than those of ADRAC and its terms of reference are enhanced.

ACSOM's role is to provide the TGA with advice about the safety aspects of medicines, and the detection, assessment, understanding and prevention of adverse effects.

Up to 12 members may be appointed to ACSOM. At present, ACSOM is made up of nine members including seven medical experts, one pharmacist and one consumer health expert. The inaugural Chair is epidemiologist Professor Emily Banks.

ADRAC's traditional publication, the ADRAC Bulletin, will be replaced by the ACSOM publication, "Medicines Safety Update" which is published on the TGA website and in Australian Prescriber.

ACSOM does not replace the spontaneous reporting system for adverse events (ie. the blue card system) which has been used in Australia for many years.

ACSOM and risk management plans

One of the key objectives of ACSOM is to provide expert advice on risk management plans to the TGA as part of the safety assessment of new medicines.

In April 2009 the TGA formally adopted the European Guideline on Risk Management Systems for Medicinal Products for Human Use (EMEA/CHMP/ 96268/2005). The adoption of the European Guideline means that a Risk Management Plan must be included in applications for the registration of certain higher risk prescription medicines.

The aim of these plans is to document not only what is known about the safety of the medicine at that particular point in time (the Safety Specifications), but also potential risks that require further consideration, and how the sponsor intends to investigate those risks.

This move is consistent with the global trend towards increased safety standards, risk minimisation and accountability.

Australian Public Assessment Report (AusPAR)

An AusPAR is an initiative which has been introduced to increase the transparency of the way in which the TGA evaluates prescription medicines. The introduction of the AusPAR is a result of a lengthy review and consultation process. It brings Australia into line with the international trend towards transparency and the publication of evaluation summaries, as is the practice of the European Medicines Agency and United States Food and Drug Administration.

AusPARs will be released by the TGA as a result of any application seeking to introduce a new medicine or constituting a major change to an existing prescription medicine (in broad terms, a Category 1 application). A report will focus on the evaluation of the safety, quality and effectiveness of the product.

In broad terms, the TGA has indicated that the structure of an AusPAR will be:

  • Introduction: Basic information about the product, extracted from the submission;
  • Quality: Summary of the quality aspects of a product;
  • Non-clinical: Summary of the non-clinical safety aspects of a product;
  • Clinical: Summary of the clinical efficacy and safety aspects of a product;
  • Pharmacovigilance: Summary of the pharmacovigilance systems and risk management activities of a product; and
  • Conclusion: Summary of salient issues identified during evaluation and sets out the rationale for the decision by the delegate. [1]

For applications involving new generic medicines the AusPAR will contain an extract of the decision letter, a statement of bioequivalence and the approved Product Information.

Balancing disclosure and confidential information

AusPARs mean that, for the first time, a substantial amount of information about the TGA's assessment of new medicines will be publicly available. A critical issue is how the TGA strikes an appropriate balance between disclosing information and protecting information that is commercially confidential.

This requires sponsors to actively engage in determining the content of each AusPAR with the TGA. A sponsor will have 14 days to review a draft AusPAR and make a submission to the TGA about whether information ought to be excluded from the document because it is commercially confidential. A sponsor may also suggest an alternative form of words to be included in the document.

Amendments to the underlying legislative scheme, provide some guidance about how the TGA will determine what information should and should not be disclosed in an AusPAR. Section 61 of the Therapeutic Goods Act 1989 (Cth) gives the TGA the power to release a wide variety of information, for example, advice from the Australian Drug Evaluation Committee about whether an application for registration ought to be approved. The powers do not require disclosure, they simply allow it. The powers of disclosure are also limited by other laws such as privacy, freedom of information and free trade laws. It will be particularly interesting to see how the TGA ultimately exercises these powers.


Thanks to Richard Abraham for his help in writing this article

This article was first published by the Association of Regulatory and Clinical Scientists in Australia ARCS Newsletter, Issue No 8, April 2010, 19-20


[1] TGA Australian Public Assessment Report (AusPAR)for Prescription Medicines Guidance Document (June 2010) at page 4 [jump back to article]

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Clayton Utz communications are intended to provide commentary and general information. They should not be relied upon as legal advice. Formal legal advice should be sought in particular transactions or on matters of interest arising from this communication. Persons listed may not be admitted in all States and Territories.