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Results: 1-10 of 13

Global Pricing Newsletter: volume two

  • Sidley Austin LLP
  • -
  • China, Global, United Kingdom, USA
  • -
  • February 27 2013

Pharmaceutical and biologic manufacturers operate in an increasingly global economy where legal developments in one market may have cascading impacts

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

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

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

Updates on international pricing issues for pharmaceutical and biologic products

  • Sidley Austin LLP
  • -
  • China, European Union, France, Germany, United Kingdom, USA
  • -
  • May 18 2012

Sidley Austin LLP’s Global Life Sciences Team is pleased to provide you with this Global Pricing Newsletter, the first in a periodic series updating clients and friends of the firm on pricing issues around the world that may have an impact on pharmaceutical and biologic manufacturers’ legal and business strategies

China’s health ministry issues recall rules for medical devices

  • Sidley Austin LLP
  • -
  • China
  • -
  • June 23 2011

The Ministry of Health (“MOH”) of the Peoples Republic of China recently promulgated Tentative Measures on the Administration of Recalls concerning Medical Devices (“Medical Device Recall Rules”), which will be effective on July 1, 2011

China unveils draft regulations on labeling requirements for health foods

  • Sidley Austin LLP
  • -
  • China
  • -
  • June 7 2011

The State Food and Drug Administration ("SFDA") recently published an updated draft of the Rules on the Administration of Product Insert Sheets and Labels of Health Foods ("Draft Labeling Rules") for public comments

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"

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