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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

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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Rare Diseases: Pre-Clinical Studies And Clinical Trials In Orphan Drug Development

The development of drugs in rare diseases provides great opportunities to pharma companies along with challenges that are required to overcome during drug discovery, pre-clinical, and clinical stages of drug development. Commercially rare diseases drug development differs from traditional diseases, as there are considerably few patients to take the drug, therefore pharmaceutical companies should consider […]

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

Regulatory approval process for Nutraceuticals/Complementary medicines in Australia

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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Rare Diseases: Clinical Trials & Drug Development

Rare disease drug development is a rapidly expanding field with growing pressure for getting a more orphan drugs 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 […]

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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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What is the best EDC system / eCRF you’ve ever used? Review of online user-initiated surveys on social media

best_EDC_eCRF_systems_user_initiated_surveys_Credevo

A case record form (CRF) is a great and necessary tool used in clinical trials to collect data from each participating patient. CRF (also referred to as case report form) has historically been on paper (unlike electronic ones these days). Traditionally, something like carbon copy paper, where the sponsor can utilize one sheet for the Trial Master […]

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