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Results: 1-10 of 30

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On August 1, 2012, the Ministry of Health of China (“MOH”) issued the draft Guidance on Strengthening Anti-Bribery Control at Public Hospitals


China’s new drug GMP significantly raises drug manufacturing standards
  • Sidley Austin LLP
  • China
  • February 17 2011

On February 12, 2011, after rounds of revisions that took more than 5 years, the Ministry of Health of China ("MOH") published the final version of China's new drug GMP ("GMP 2010"


Drug pricing reform: an opportunity and challenge
  • Sidley Austin LLP
  • China
  • March 25 2011

The Chinese National Development and Drug Commission ("NDRC"), the authority in charge of drug pricing, recently slashed the maximum retail price of 162 cardiovascular and anti-infective drug products by an average of 21


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


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


Chinese CDE launches joint review for chemical drug and API applications and other life sciences regulatory updates
  • Sidley Austin LLP
  • China
  • June 16 2011

The Center for Drug Evaluation (CDE) of the Chinese State Food and Drug Administration (SFDA) released a notice on June 7, 2011, establishing joint review for applications for chemical drugs and their active pharmaceutical ingredients (APIs) with a view to improving drug approval efficiency


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


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


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