Category: Regulatory

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What You Need to Know to Register Nutraceutical, Dietary Or Food Supplement Products In Europe – Part I

Nutraceuticals, dietary supplements, or food supplements, also known as “Health Supplements,” have been used for years to maintain, enhance, and improve the healthy function of the human body. They may contain a combination of vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, and other bioactive substances. Each country differs in its regulatory requirements for registration […]

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Regulatory Approval For Nutraceuticals (Complementary Medicines) In Australia Part-II

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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What would you ask China FDA officials that can improve your clinical trials and product registrations experience in China?

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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Clinical Trial Requirements and Practical Scenario for Marketing Approval in China

Do you know any product segment where one does not get to encounter Chinese products? Well, hardly any. It has been the focus of the 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 […]

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Regulatory Approval For Nutraceuticals (Complementary Medicines) In Australia Part-I

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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Thailand Latest Approved IRB List: Update 2

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

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Clinical Trial Regulatory Process – Brazil

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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New Zealand – Clinical Trial Regulatory Process

New Zealand could be an interesting choice of region for national and international organizations seeking to pursue clinical trials and looking for the most preferred destination in the Asia-Pacific Region. The information in this article was last updated in Oct 2024. New Zealand, a country named the third most beautiful country in the world with stunning and […]

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