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FDA proposes two groundbreaking food safety rules

  • Sidley Austin LLP
  • -
  • USA
  • -
  • January 8 2013

On January 4, 2013, the U.S. Food and Drug Administration ("FDA" or the "Agency") proposed two major, long-awaited rulemakings required by the Food Safety

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

Extended scope EU Penalties Regulation enters into force

  • Sidley Austin LLP
  • -
  • European Union
  • -
  • July 13 2012

As of 2 July 2012, infringements of the EU’s paediatric and new pharmacovigilance rules fall within the scope of the revised EU Penalties Regulation and are now subject to financial penalties of up to 5 percent of the marketing authorization holder’s annual EU turnover

FDA guidances pose regulatory challenges for functional foods

  • Sidley Austin LLP
  • -
  • USA
  • -
  • January 29 2014

The Food and Drug Administration recently finalized two guidance documents for dietary supplement manufacturers, one focused on Distinguishing Liquid

China's new SFDA priorities

  • Sidley Austin LLP
  • -
  • China
  • -
  • February 1 2011

The General Commissioner of the State Food and Drug Administration ("SFDA") unveiled six key priorities of the agency in 2011 at the General Assembly of Food and Drug Administrations in China

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

New age of Singapore’s regulations of medical devices

  • Sidley Austin LLP
  • -
  • Singapore
  • -
  • June 9 2011

In the past several years, Singapore has been in the process of revamping its regulatory regime for health products

European Union adopts falsified medicines directive

  • Sidley Austin LLP
  • -
  • European Union
  • -
  • June 7 2011

On May 27, 2011 the Council of the European Union (Council) adopted a directive aimed at preventing falsified medicines from entering into the legal supply chain

Senate passes food safety legislation: food product and dietary supplement implications

  • Sidley Austin LLP
  • -
  • USA
  • -
  • December 7 2010

On November 30, 2010, the Senate approved the long-awaited Food Safety Modernization Act, S. 510, by a 73-25 vote

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