Titlebook: Approaching China‘s Pharmaceutical Market; A Fundamental Guide Ming Q. Lu Book 2015 Springer International Publishing Switzerland 2015 CFD

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legislate

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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

罵人有污點

FEIGN

新字

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

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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

ANTH

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

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Chinese State Food and Drug Administration (SFDA) and the C?This 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