Ming Q. Lu's Approaching China's Pharmaceutical Market: A Fundamental PDF

By Ming Q. Lu

ISBN-10: 331915575X

ISBN-13: 9783319155753

ISBN-10: 3319365711

ISBN-13: 9783319365718

​This authoritative quantity examines the main legislation, rules and guidance with regards to pharmaceutical product improvement in China. With a spotlight on patent, medical and registration techniques, the publication is helping Western businesses introduce their scientific medicinal drugs to the chinese language industry, make certain a strategic direction and bridge the distance for regulatory and felony modifications among China and the Western international. For a greater figuring out of the drug registration strategy, it explores the diversities among the China nutrition and Drug management (CFDA)—including its rules and registration procedures—and these of the Western international. the amount discusses disparities among China's program requisites in comparison to Western criteria to make it more uncomplicated for firms to arrange their program applications. It additionally offers targeted remark on CFDA instructions in connection with medical trial (IND) and industry software (NDA) requisites.   total, this publication deals tips for Western businesses meaning to extend into China’s pharmaceutical industry in hopes that they might achieve a primary figuring out of its ideas and complexities so that it will ascertain a tender transition and stop destiny issues.

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Approaching China's Pharmaceutical Market: A Fundamental Guide to Clinical Drug Development by Ming Q. Lu

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