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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Do you know any product segment, where one does not get to encounter Chinese products? Well, hardly any. It has been the focus of Chinese government for the past several decades to dominate various industrial sectors, including pharmaceuticals. While, China has been the big production factory for generic drugs and API ingredients for many years, […]

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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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Brazil has grown exponentially in clinical research over the last decade. During the past 3 years, clinical trials in Brazil have grown significantly, with the country becoming one of the three most dominant emerging countries, along with India and Russia, which together attract the highest number of Western companies outsourcing clinical trials. Brazil is a […]

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Case record form (CRF) is a wonderful and necessary tool used in clinical trials to collect data from each participating patient. CRF (also, referred as case report form) have historically been on paper (unlike electronic ones these days). Traditionally, something like carbon copy paper have been used, such that one sheet can be added to […]

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Over a million people are currently living with TB in Indonesia, making up more than 10% of the world’s TB burden. Of the estimated 32 000 new cases of drug-resistant TB in the country, only about a third of these cases were detected. In a country with a high malaria burden, less than 1% of […]

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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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