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Results: 1-10 of 37

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

Relaxation of overseas listing requirements for P.R.C. companies by the CSRC good news?

  • Sidley Austin LLP
  • -
  • China
  • -
  • January 11 2013

The eagerly anticipated relaxation to the P.R.C. rules on the listing of joint stock companies overseas has finally materialized. With effect from

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

SFDA issues draft rules to define its discretionary power in imposing administrative penalties

  • Sidley Austin LLP
  • -
  • China
  • -
  • September 27 2012

On September 19, 2012, China’s State Food and Drug Administration (“SFDA”) issued draft Rules on Exercising Discretionary Powers when Imposing Administrative Penalties involving Drugs and Devices (“Draft Rules”), soliciting public comments by September 26, 2012

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

Impact of China’s new exit-entry control law on expatriate employees and their employers

  • Sidley Austin LLP
  • -
  • China
  • -
  • July 26 2012

On June 30, 2012, China formally enacted the new Exit-Entry Administration Law (the “New Law”

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