Do you know according to clinicaltrials.gov a total of 354,130 clinical trials were registered worldwide with 71,256 ongoing trials as recorded on Oct-2020? The number of trials being conducted is increasing year by year from 56.16k in 2017 to 60.69k in 2018. In the US more than 2.3+ million people participate in approximately 80,000+ clinical […]

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Clinical trials in rare diseases are more challenging than clinical trials in more frequent diseases for many factors such as the trial design, the number of patient populations available for recruitment, require regulatory support, etc. Applying a perfect clinical development strategy may help in overcoming these challenges and accelerate the drug development process in Orphan […]

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Drug development is a lengthy, complex, and costly process, entrenched with a high degree of uncertainty that a drug will actually succeed and reach the market successfully. Drug development is the process of bringing a new pharmaceutical drug or a medical device or a treatment procedure to the market. Many developers often lack a clear […]

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One of the most sought after markets for medical devices in the world is the Australian market. With the regulatory reforms and an increase in demand for innovative products, the Australian medical device market is expected to be worth more than $4.56 billion by 2025 growing at a CAGR of 10%. There is a growing […]

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Many people with rare diseases struggle to find the right diagnosis and right treatment for years. The lack of awareness about these conditions make it much harder for them to get the right treatment. Rare Disease Day is all about raising awareness for rare diseases. And, this year, you can join these efforts too. The […]

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In a way to support and encourage pharma companies to work upon developing drugs or medical devices in rare disease, several country regulatory agencies are coming up with various benefits such as faster approvals, fee concessions and financial benefits etc. These countries include the US, Europe, Japan, Australia, South Korea and most recently, India. Incentives […]

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Do you know that Australian complementary medicines are viewed as the consumer protection benchmark internationally? Numerous complementary medicines are recognized as a premium brand in Australia and internationally. The obvious reason being – Australia’s complementary medicines industry is proudly backed by a regulatory regime that is regarded as one of the strictest in the world! […]

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Australian regulators do not distinguish between medicines and complementary medicines when it comes to the safety, efficacy, and quality of the product, including the imported products! Read the first part of this series – Regulatory Approval for Complementary Medicines in Australia Part-I – to understand what complementary medicines are and how they are classified in Australia. […]

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If you wish to market your vitamins, minerals, nutraceutical products, dietary supplements, and herbal products in the Australian market, it will be better to realize that the Australian regulatory requirements are quite different from other countries for such products. For example, in the United States of America (USA), such products can reach the pharmacy store, […]

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What do you call a country with quality research facilities, efficient ethics, and regulatory framework, diverse participant recruitment pool, research tax incentives and flexibility in conducting research? Some call it a dream destination, others Australia! It’s a country that has the world’s best researchers and health professionals, boasts a world-class research infrastructure and high standards […]

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