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Results: 1-10 of 30

SDFA clarifies requirements for Foreign Pre-Clinical Data
  • Sidley Austin LLP
  • China
  • November 3 2011

As more and more local drug applicants use pharmacological and toxicological data generated from foreign pre-clinical studies (the Foreign Pre-Clinical Data) to support their regulatory filings in China, SFDA recently stated that it will require local applicants to provide additional, notarized and legalized supporting documents to prove the reliability of the Foreign Pre-Clinical Data


SFDA regulates drug administration in medical institutions
  • Sidley Austin LLP
  • China
  • November 2 2011

In order to regulate the safe use of drugs by medical institutions, SFDA promulgated Measures on Drug Supervision and Administration in Medical Institutions (Trial Implementation) (the Measures) on October 11, 2011


China drug supply chain and GXP update
  • Sidley Austin LLP
  • China
  • January 4 2012

On December 23, 2011, the State Food and Drug Administration (SFDA) of China published the latest round of proposed revisions to the Drug Good Supply Practice Regulation (Draft GSP) for public comment by January 13, 2012


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 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


China SFDA imposes new regulatory requirements on cross-border pharmaceutical contract manufacturing activities
  • Sidley Austin LLP
  • China
  • August 15 2011

On July 22, 2011, the China State Food and Drug Administration (“SFDA”) published a notice on strengthening its supervision over domestic contract manufacturing activities for foreign pharmaceutical manufacturers (the “Notice”), with an aim to prevent export counterfeiting


China issues new rules to tackle conflict of interest of healthcare government officials
  • Sidley Austin LLP
  • China
  • January 12 2012

On December 26, the Chinese Ministry of Health (MOH) issued the Rules on Prohibition of Conflict of Interest for Healthcare Officials


Chinese government publishes Vaccine Supply System Development Plan
  • Sidley Austin LLP
  • China
  • January 11 2012

On December 22, the State Council of China published the Vaccine Supply System Development Plan


China issues new rule on medical device advertisements
  • Sidley Austin LLP
  • China
  • June 5 2009

On May 13, the Ministry of Health (MOH), the State Administration of Industry and Commerce (SAIC) and the State Food and Drug Administration (SFDA) of China jointly issued an amended Rule for Review of Medical Device Advertisements (the Rule) and accompanying Standards for Review of Medical Device Advertisements (the Standards), both of which went into effect on May 20


China proposes new drug GMPs, significantly raising standards
  • Sidley Austin LLP
  • China
  • October 28 2009

On September 23, the State Food and Drug Administration of China ("SFDA") published a draft of revised drug good manufacturing practices ("GMP") for public comments ("GMP 2009"