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China Enhances Data Management, Communication For IND Approvals

This article was originally published in PharmAsia News

Executive Summary

The Center for Drug Evaluation is making headway to improve the IND process, but it is still a long road ahead.

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SHANGHAI - For years, China has talked about revising its drug review system to improve efficiency, and now major changes are in the works with China's State FDA reforming its drug review body, the Center for Drug Evaluation, to encourage drug innovation and facilitate globalization of its drug review process

China And Taiwan Move Toward Clinical Data Mutual Acceptance, Regulatory Harmonization

China and Taiwan's top health regulators have signed an agreement to harmonize clinical and non-clinical studies toward mutual data acceptance. The deal could open doors for more Taiwanese drugs in the Chinese market, industry experts say

More Talks Needed With China and Japan For Cooperation In Sharing Clinical Data - Korea FDA Official

SEOUL - Although drug regulatory officials from South Korea, Japan and China met in Beijing for two days from Dec. 17 in their second tri-party meeting, they failed to report "noticeable progress" in their pursuit of an integrated clinical trial data-sharing program and mutual acceptance of their rules and guidelines, according to Korea FDA

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