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China Overhauls ADR Reporting Regulations That Place Additional Responsibility On Drug Makers

This article was originally published in PharmAsia News

Executive Summary

SHANGHAI - China's State FDA released new guidelines for adverse drug reaction reporting May 24 that will dramatically increase the postmarket reporting responsibilities of manufacturers, distributors and hospitals

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China's New ADR Reporting Regulations Still Leave Uncertainty For Clinical Requirements

SHANGHAI - China implemented revised guidelines for adverse drug reaction reporting July 1 to increase postmarket reporting responsibilities of manufacturers, distributors and hospitals. However, the regulations need to be improved to provide specific responsibilities and qualifications for company-appointed ADR monitors as well as how to deal with adverse drug reactions during clinical research, according to a clinical expert

China's New ADR Reporting Regulations Still Leave Uncertainty For Clinical Requirements

SHANGHAI - China implemented revised guidelines for adverse drug reaction reporting July 1 to increase postmarket reporting responsibilities of manufacturers, distributors and hospitals. However, the regulations need to be improved to provide specific responsibilities and qualifications for company-appointed ADR monitors as well as how to deal with adverse drug reactions during clinical research, according to a clinical expert

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