虚弱
发表于 2025-3-25 03:23:05
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legislate
发表于 2025-3-25 10:19:51
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ARCHE
发表于 2025-3-25 12:30:24
Guidance for Application Materials/Booklets (Chemical), definitions and dossier application requirements for various drug categories and classes in the acceptance, review, approval, and overall registration processes. The regulation also clarifies the requirements for source data review, criteria for on-site inspection and product quality inspection. Si
骂人有污点
发表于 2025-3-25 17:29:32
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FEIGN
发表于 2025-3-25 22:59:37
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新字
发表于 2025-3-26 01:10:14
Strategic Drug Development in China and Surrounding Countries, register their investigational drugs in China. Companies favor IMCT since it allows sharing of global drug development resources, synchronizes global drug research and development processes, reduces cost by avoiding unnecessary repetition of clinical trials, and shortens the time gaps in drug marke
IST
发表于 2025-3-26 05:52:29
Drug Safety Monitoring and Reporting Systems in China, West’s, making it harder for multinational companies to run their clinical trials and manage their marketed drugs. In this chapter, we will briefly review the history of safety-related regulations, current safety-monitoring regulations, and reporting requirements for the investigational drugs in th
Mendicant
发表于 2025-3-26 09:06:02
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ANTH
发表于 2025-3-26 16:27:02
Book 2015 patent, clinical and registration strategies, the book helps Western companies introduce their clinical drugs to the Chinese market, determine a strategic path and bridge the gap for regulatory and legal differences between China and the Western world. For a better understanding of the drug registr
exceptional
发表于 2025-3-26 20:15:15
Chinese State Food and Drug Administration (SFDA) and the CThis authoritative volume examines the major laws, regulations and guidelines related to pharmaceutical product development in China. With a focus on patent, clinical and registration strategies, the book helps Western companies introduce