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Advisory Committee on the Safety of Medicines (ACSOM)

Role of the ACSOM

The Advisory Committee on the Safety of Medicines (ACSOM) was formed in January 2010 to advise and make recommendations to the TGA on the:

  • safety of medicines
  • risk assessment and risk management of medicines

ACSOM may also provide advice to the TGA on other matters related to the detection, assessment, understanding and prevention of adverse effects, known as pharmacovigilance, and any other matters referred to it by the TGA.

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

A major role for ACSOM is to provide advice on the quality and appropriateness of risk management plans which are designed to define and pro-actively manage risks relating to a medicine over its entire life cycle.

In 2017, ACSOM was replaced by the Advisory Committee on Medicines (ACM).