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GRC Professional : GRC Spring 2012
23 clinical trials [see diagram: 'A brief history of drug regulation']. All medicines commercially supplied in Australia are manufactured according to Good Manufacturing Principles (GMP), which control quality and purity of the ingredients. Their distribution, availability and marketing are stringently regulated according to the risks they present to the consumer. Hence, complementary medicines such as fish-oil capsules and vitamins can make low-level, untested claims of effectiveness for mild conditions or general health, while over-the-counter (OTC) drugs like Aspirin and paracetamol can make stronger claims to relieve pain, and stronger medicines are available on prescription only and cannot be marketed direct to the consumer. Depending on a medicine's risk profile, its ma nufacture, supply, claims, and promotion may be bound by: the Therapeutic Goods Act, enforced by Australia's regulatory authority the Therapeutic Goods Administration (TGA); the codes of conduct and/or practice of industry peak bodies Medicine Australia (MA) for prescription medicines, the Australian Self-Medication Industry for OTC therapies, and Complementary Healthcare Council for supplements; and its scheduling under individual state and territory legislation. Trials and tribulations After research and developing cell cultures in laboratories, it can take more than a decade until a drug is registered and released to market because of the time taken to do studies in animals, get necessary approvals from research institutes with ethics committees, and do controlled, multi-phase trials in humans. Compliance issues are present through the life cycle of a pharmaceutical, says Rob Creek, Medical Director for the Australian offices of German-based multinational Boehringer Ingleheim He is responsible for the clinical trials his company performs to gain registration for new prescription medicines it develops. His regulatory department must meet the TGA's packaging regulations and licensing products specifications, usually in X More than 100 people in the US die after using an elixir contaminated with the solvent diethylene glycol. Facilitates introduction of the US Federal Food, Drug and Cosmetic Act with the pre-market notification requirement for new drugs in 1938. 1937 » A BRIEF HISTORY OF DRUG REGULATION Proprietary medicines populate an unregulated market, many of them 'quack' remedies making amazing claims. State governments moved to control claims while the Commonwealth strengthened controls on imported biological products. Until 1938 The Therapeutic Substances Act 1953 legislated to regulate the standards for medicines while a multinational industry was rapidly evolving the sophistication and variety of products. 1939 - 1961 The pre-market assessment of quality, safety and efficacy evolved and was integrated into a national system of regulation for medicines, vitamins and devices (under the Therapeutic Goods Act 1989) and the establishment of the TGA. 1962 - 1988 The national system continued to mature into an internationally harmonised regulatory system, reflecting the increasing globalisation of markets. Risk- managed regulation -- each of the classes of therapeutic goods being regulated relative to their risk. 1989 - 2007 Thalidomide, a drug used for countering morning sickness, is withdrawn after reports of birth defects. December 1961 Contaminated travel sickness drug leads to Pan Pharmaceuticals recall of complementary and OTC medicines -- the biggest in world history. April 2003 Contaminated polio vaccines distributed by Cutter Laboratories infect 204 people and kill 11 in California and Idaho, US. April--May 1955
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