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Results: 1-10 of 27

PRC Ministry of Health issues measures on centralized procurement of high value medical devices

  • Sidley Austin LLP
  • -
  • China
  • -
  • January 23 2013

On December 17, 2012, the Ministry of Health ("MOH") issued a new regulation that subjects certain high-value medical devices to a centralized

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

China issues new draft regulation on human genetic resources

  • Sidley Austin LLP
  • -
  • China
  • -
  • November 2 2012

China’s State Council published a draft Regulation on Administration of Human Genetic Resources on October 30, 2012 soliciting public comments by November 29, 2012

SFDA finalizes its rules on packaging and labeling of imported medical devices

  • Sidley Austin LLP
  • -
  • China
  • -
  • October 9 2012

On September 24, 2012, China’s State Food and Drug Administration (SFDA) issued the final Notice on Further Regulating Labeling and Packaging of Medical Devices Manufactured Overseas (the “Notice”), which will become effective on April 1, 2013

China promulgates a PSUR guidance for approved drugs

  • Sidley Austin LLP
  • -
  • China
  • -
  • September 25 2012

On September 13, 2012, the State Food and Drug Administration (“SFDA”) published a Technical Guidance for the Periodic Safety Update Report for Marketed Drugs (the “PSUR Guidance”

Chinese Ministry of Health issues guidance to strengthen anti-bribery control at public hospitals

  • Sidley Austin LLP
  • -
  • China
  • -
  • September 6 2012

On August 1, 2012, the Ministry of Health of China (“MOH”) issued the draft Guidance on Strengthening Anti-Bribery Control at Public Hospitals

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

NDRC takes serial measures to reduce drug prices

  • Sidley Austin LLP
  • -
  • China
  • -
  • May 14 2012

It has long been a policy objective of the Chinese Government to reduce drug prices in China while ensuring drug quality

MOH publishes new draft of Drug GSP regulation

  • Sidley Austin LLP
  • -
  • China
  • -
  • May 11 2012

On April 25, the Ministry of Health of China published a new draft of the Drug GSP for public comment, and key changes are:

China issues five-year plan for pharmaceutical and medical device industries

  • Sidley Austin LLP
  • -
  • China
  • -
  • January 20 2012

On January 19, 2012, the Chinese Ministry of Industry & Information Technology issued the Twelfth Five-Year Plan (2011-2015) for the Development of Pharmaceutical and Medical Device Industries (the Plan