Sourcing or importing the IMPs and their supportive products is a challenging process for many researchers and this is more prominent with the countries like China and Japan where understanding the regulations is difficult due to the language barriers and rapid changing norms for making imports.  Many key players in logistics are unclear about the […]

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As clinical trials have become increasingly global and complex, ancillaries have grown in volume, type, and expectations. The clinical trials supplies market is projected to reach  USD 2.5 billion by 2025 owing to the logistics services with the increasing number of clinical trials involving temperature-sensitive drugs. Currently, North America is the largest market for clinical […]

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Clinical trials in rare diseases present more significant challenges compared to trials in more common diseases. These challenges arise due to various factors, including trial design, the limited patient population for recruitment, regulatory support, and more. However, implementing a well-defined strategy for clinical development in rare diseases can help overcome these challenges. Such a strategy […]

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In recent years, there is a huge leap in the pharma industry towards rare disease research and orphan drug developments due to the great support from regulatory authorities such as faster approval timelines, supportive regulatory frameworks, financial incentives, and many more. Currently, large pharmaceutical companies like Novartis, GSK, Roche, and Pfizer are extremely active in […]

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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 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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China has brought significant reforms in its regulatory system for pharmaceutical industry and clinical trials. In its continuous drive to improve the system, recently China’s Food and Drug Administration (CFDA) announced a major overhaul of its medical device regulations as well. To the current regulations, China has made significant changes. Summarily, 12 articles were newly […]

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China is the largest clinical trial market in Asia and the 5th largest in the world. In recent years there was a remarkable increase in Phase I-III clinical trials. Understandably, there must be something significant happening, which brought this change. The recent changes in policies and regulations in China have brought a lot of cheer from […]

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