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Results: 1-6 of 6

China encourages pharmaceutical companies to timely pursue new GMP certification

  • Sidley Austin LLP
  • -
  • China
  • -
  • January 15 2013

In 2010, China's State Food and Drug Administration ("SFDA") issued a new version of its Good Manufacturing Practice (the "GMP") regulations, which

New Chinese medical device GCP unveiled for public comments

  • Sidley Austin LLP
  • -
  • China
  • -
  • September 4 2012

The Chinese State Food and Drug Administration (“SFDA”) published the revised Medical Device Good Clinical Practice (“Medical Device GCP”) in late August and is soliciting public comments until September 30, 2012

SFDA to enforce blacklist system for unsafe drug and device products

  • Sidley Austin LLP
  • -
  • China
  • -
  • August 21 2012

Beginning October 1, 2012, China’s State Food and Drug Administration (SFDA), including its provincial counterparts, will implement a nationwide information disclosure system called the Drug Safety Blacklist (“Blacklist”), which includes medical device products as well

China SFDA publishes new technical review guidelines for drugs

  • Sidley Austin LLP
  • -
  • China
  • -
  • March 29 2011

On March 23, 2011, the Center for Drug Evaluation (CDE) of the PRC State Food and Drug Administration (SFDA), the equivalent of the Center for Drug Evaluation and Research of the U.S. Food and Drug Administration, published new guidelines for its technical review of drug registration applications in China (the Guidelines), including applications for clinical studies (IND), applications for production and market approvals of new drugs (NDA), as well as applications for generic drugs (ANDA

Major vaccine standards change in China

  • Sidley Austin LLP
  • -
  • China
  • -
  • January 24 2011

The State Food and Drug Administration ("SFDA") recently issued the Notice for Further Strengthening the Supervision of Quality and Safety of Vaccines ("Vaccine Notice"

China proposes new ADR reporting rule

  • Sidley Austin LLP
  • -
  • China
  • -
  • July 30 2009

On June 30, the Ministry of Health ("MOH") and the State Food and Drug Administration ("SFDA") of China issued a draft revision of the Rule on Adverse Drug Reaction Reporting and Monitoring (the "Reporting Rule"