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China Releases First Guideline On Clinical Trial Ethical Reviews In Effort To Improve Standards

This article was originally published in PharmAsia News

Executive Summary

SHANGHAI - China's State FDA released Nov. 2 its first guideline on the Ethical Review of Drug Clinical Trials to clarify the responsibility of ethics committees and to provide clear guidance on the ethical review process in an effort to better protect patients participating in trials

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Patient Safety First: Indian Regulator Takes Steps To Tighten Grip Over Site Inspections, Ensure Data Credibility

MUMBAI - As India moves rapidly to become an integral part of large-scale global clinical trials, the Central Drugs Standard Control Organization under the Ministry of Health and Family Welfare has declared a set of new guidelines to ensure adequate safety of trial participants

Parexel Chairman Josef von Rickenbach on Shifting CRO Models In Asia For Efficient Drug Development: An Interview With PharmAsia News (Part 2 of 2)

Roughly two-thirds of contract research organization Parexel's $1.1 billion 2010 revenue base was outside of the U.S., including about 12 percent in the Asia/Pacific region, and Chairman and CEO Josef von Rickenbach expects its share of APAC business to increase. In Tokyo for a day-long Parexel seminar to draw new clients in Japan, von Rickenbach and VP-Asia/Pacific Albert Liou spoke with PharmAsia News' Tokyo bureau about the company's shifting client base in Asia and the evolving partnership model in the CRO market in part one of this interview..

China's State FDA Steps Up Transparency With First Annual Review Of Drug Approval Process, Outcome

BEIJING - In a step toward lifting a longstanding veil on the drug review process in China, the State FDA has for the first time issued a public outline of the range and types of medicines approved by regulators last year

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