The Australian Medicines Regulatory System: A Risk-Based Approach to Regulation
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Roban Hanmett, PhD National MananeG Therapeutic Go& Administration. Australia
The Australian Medicines Regulatory System: A Risk-Based Approach to Regulation
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The article discusses the history of medicine regulation in Australia and describes the evolution of the Australian regulatory system, noting this process of evohing has been the key to the success of the Australian Therapeutic Goods Administration PG4) in protecting the public health. Future challenges facing regulators are discussed and the TGA's strategic plans to address these are referenced.
Leonie Hunt, MBBS, FRACGP, Btc, MBA Head. Office of Prescription Medicines, Therapeutic Goods Administration, Australia
Key Words Therapeutic Goods Administration; TGA: Office of Prescription Medicines; Australia; Medicine regulation; Australian Drug Evaluation Committee; ADEC; Adverse Drug Reactions Advisory Committee; ADRAC; Clinical trials; Pharmacovigilance
Correspondence Address Dr. Leonie Hunt. Office of Prescription Medicines. Therapeutic Goods Administration, PO Box 100. Woden. ACT 2606. Australia (email: Leonie.Hunt @tga.gov.au).
INTRODUCTION The system of medicine regulation in Australia developed in response to public health needs. It began with the decision to test for the quality of medicines that were considered necessary to ensure public health and that were therefore subsidized by the Australian government in the 1950s. In 1961 an Australian obstetrician, Dr. William McBride. published his observation of birth defects in association with the use of the medicine thalidomide in a letter to the Lancet. Thalidomide had been used in the management of nausea in pregnancy but its use was indeed associated with characteristic and devastating congenital abnormalities. This episode highlighted that assurance of quality in itself, while of great importance, was not sufficient to prevent tragedies from occurring. In Australia in the aftermath of this incident, a new medicines evaluation function was first established and subsequently a postmarket monitoring function. Over many years these evolved into a national system of controls that aim to meet the needs of the public in terms of both timely access to medicines and protection from poor-quality,unsafe, or ineffective products. The system of regulation has evolved as the pharmaceutical environment has changed over the years and it continues to evolve to meet the
challenges of today. Fundamentally, however, it exists to serve the needs of the public and this purpose has not changed.
THE CURRENT SYSTEM The Therapeutic Goods Administration (TGA) is responsible for the regulation of prescription and over-the-counter medicines, complementary medicines, medical devices, blood, and tissues. It does not regulate food or veterinary medicines. The TGA regulates using a risk-based approach with application of various regulatory tools to ensure an appropriate balance of regulatory burden and facilitation of access. The regulatory tools used by the TGA would be familiar to most regulatory agencies and include use
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