In the world of medical research, Australia stands as a beacon of excellence, drawing researchers and pharmaceutical pioneers from across the globe. From its efficient regulatory processes to its top-tier research infrastructure, the vast and diverse landscapes of this nation have become a preferred choice for conducting clinical trials. This article delves into the compelling […]

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The process of registering over-the-counter (OTC) medicines in Australia is regulated by the Therapeutic Goods Administration (TGA). The exact process depends on the type of product and the regulatory pathway but typically involves the submission of detailed documentation and scientific data to support the safety, quality, and efficacy of the product. What are OTC (over-the-counter) […]

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The registration of prescription medicine in Australia is straightforward, and the TGA evaluates applications for quality, safety, and efficacy. Australia ranks among the largest healthcare markets worldwide as its health system is one of the best in the world and provides quality, safe, and affordable healthcare for its citizens. The value of the Australian pharmaceutical […]

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Globally many consider herbs and botanicals to be natural and therefore healthier and gentler than conventional drugs. Currently, 30% of prescription drugs are herbal and botanical drugs. Herbals and botanicals are used for the treatment and improvement of health and well-being. Many countries use herbal and botanical drugs traditionally for many years to generations. The […]

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One of the most sought-after markets for medical devices globally is the Australian market. With the regulatory reforms and increasing demand for innovative products, the Australian medical device market expectation was worth more than $4.56 billion by 2025, growing at a CAGR of 10%. In this article, we will be discussing the medical device approval […]

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Regulatory agencies of various countries are providing benefits & regulatory incentives for orphan drugs such as faster approvals, fee concessions, and financial benefits, and many more. These incentives are to support and encourage pharma companies to work upon developing orphan drugs or medical devices for rare diseases. The countries that provide regulatory incentives include the […]

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Do you know? Global regulators consider Australian Nutraceuticals complementary medicines () the consumer protection benchmark. In Australia and internationally, numerous complementary medicines are considered premium brands. That is obvious because the complementary medicines’ approval follows a strict regulatory regime and is one of the stringent in the world!. With such high quality of these products, the Australian complementary […]

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Concerning the safety, efficacy, and quality of the product, Australian regulators review and register nutraceuticals, same as pharmaceutical products, concerning the safety, efficacy, and quality of the product. To register herbal, animal, cosmetics, vitamins, or mineral products in Australia, one needs to take the route of the Complementary registration process. Read the first part of […]

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Do you wish to market your nutraceuticals/complementary medicines (vitamins, minerals, nutraceutical products, dietary supplements, and herbal products) in the Australian market? Then it is better to realize that the Australian regulatory requirements are different from other countries for such products. For example, in the United States of America (USA), by filing the GRAS status (Generally Recognized […]

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Australia has the world’s best researchers and health professionals, a world-class research infrastructure, and high standards for clinical trial conduct, which leads to quality, increased speed, and high confidence in the results. Note: This article was last updated in April, 2023. They have quality research facilities, an efficient ethical and regulatory framework, a diverse participant […]

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