China’s pharmaceutical drug market is constantly growing and is the second-largest pharmaceutical industry in the world, after the United States. It is estimated to reach $161.8 billion by 2023, with an average growth rate of 5% in the coming years, taking a 30% share of the global market. The acceleration of new drug access, changing […]

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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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Report on the Drug Registration Process in China To register your drug in China, you need to know the following details What are the different categories of drug products in China? Which category does a specific product belong to? What are the documents required to register the specific category of drugs? What is the applicable […]

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IMPs Import Regulation, Requirements & Process In China Import of IMPs into China for Clinical trials IMPs and their supportive products are crucial for any clinical trial and timely delivery to the clinical trial sites matters a lot for trial initiation and conduction. Understanding the thorough regulations is very important before making such an import. […]

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Import of Clinical Ancillary Supplies into China To make a successful importation you need to answer the following questions related to the import of clinical ancillary supplies into China. What are the regulations for the import of ancillary supplies in China? Do we need to classify the ancillary products? If yes, how are ancillary products […]

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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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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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