Nutraceuticals or Health supplements are gaining importance and becoming a part of the consumer’s daily diet. With the increase in life expectancy and subsequent increase in lifestyle-related diseases, nutraceutical or health supplements have emerged as a necessity for consumers, especially in a developed market and Europe is not an exception to it! Novel food represents […]

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Cost and time for clinical development constitute more than 70% of total development of any drug! Small – mid scale biopharma are known for their innovative approaches, agility and faster developments. However, clinical development has always been one step too important, yet too hard for them. There are ways to overcome these challenges and optimize […]

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Do you know that Australian complementary medicines are viewed as the consumer protection benchmark internationally? Numerous complementary medicines are recognised 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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Nutraceutical, dietary or food supplement products, also known as “Health Supplements” have been in use since many years to maintain, enhance and improve the healthy function of human body. These may contains one or more, or a combination of vitamins, minerals, amino acids, fatty acids, enzymes, probiotics and other bioactive substances. Each country differs in […]

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Australian regulators do not distinguish between medicines and complementary medicines when it comes to 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. To […]

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Revised Chinese regulations that brought a lot of changes in clinical trials and product registrations were received with lots of questions. If you have got questions that are yet unanswered, you are not alone. Many researchers, developers and managers are not sure about one aspect or another on how to comprehend, act or change their […]

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If you wish to market your nutraceutical products, dietary supplements and herbal products in 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 product can reach the pharmacy store, supermarket and retail stores […]

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Rare disease drug development is a rapidly expanding field with growing pressure for getting more orphan drug approved to treat rare diseases. There is a vast consensus among patients, health care bodies, governments etc. to expedite drug development in this field. Some wonderful numbers that attest to growing interest in rare diseases and orphan drugs […]

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Thailand FDA periodically releases list of of institutional review boards (IRBs) / ethics committees (ECs) that it recognizes for acceptance of clinical trials. Under Thailand regulatory system, approved ethics committees serve as the main point of approvals for initiating clinical trials in the country. This has been explained in our previous articles (see Part I and Part II), […]

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Sri Lanka was one of the first countries to embrace the concept of clinical trial registration.  The SLCTR was recognized as a Primary Registry of the Registry Network of the WHO‐ICTRP in March 2008, being the fourth Primary Registry to join the Network.   Why Sri Lanka? Sri Lanka is an emerging market for clinical trial […]

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