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    Asia Regulatory Roundup: CFDA Revises Preclinical Guidance (23 August 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Revises Guidance on Preclinical Studies China Food and Drug Administration (CFDA) has released revised draft guidance on preclinical studies for consultation. The text sets out CFDA’s expectations for the gamut of factors that go into running preclinical studies, from the skills and responsibilities of laboratory staff to the design of facilities. CFDA established i...
  • China's SFDA Announces Major Reforms to Drug Regulatory Process

    China's State Food and Drug Administration (SFDA) has announced that it is implementing a series of reforms designed to improve the drug review and approval process, "and to promote the healthy development of China's pharmaceutical industry."  Wang Lifeng, director of the SFDA's drug registration department, said the plan provides incentives for the research and development of innovative clinical drugs, adding that the approval process will be shortened for these...
  • Former FDA Commissioner Calls for Agency Reforms

    The former Commissioner of the US Food and Drug Administration (FDA), Andrew von Eschenbach, has more than a few ideas about improvements that could be made to the agency he used to lead. In a series of articles, Eschenbach, now with The Manhattan Institute's Project FDA, has argued on behalf of making some potentially radical changes at the agency. In a February 2011 Wall Street Journal opinion piece , Eschenbach argued on behalf of a safety-based approval system in...