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Results: 1-10 of 30

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"


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


China strengthening controls over human genetic resources
  • Sidley Austin LLP
  • China
  • June 21 2011

The Ministry of Science and Technology (“MOST”), the Ministry of Health (“MOH”) and the National Population and Family Planning Commission (“MPFPC”) of the Peoples Republic of China jointly issued a Notice Concerning the Protection and Administration of Human Genetic Resources (“HGR Notice”) on June 2, 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


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


China issues rules on drug pricing investigation
  • Sidley Austin LLP
  • China
  • November 28 2011

On November 9, 2011, China’s National Development and Reform Commission (NDRC) released a regulation entitled Trial Measures for Investigation on Ex-Factory Prices of Drugs, which will enter into effect on December 1, 2011


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


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 comprehensive health care reform plan: implications for pharmaceutical and device firms
  • Sidley Austin LLP
  • China
  • April 9 2009

On April 6, the State Council of China made public the Guideline on Further Reforming the Health Care System (the Guideline), and on the following day the Action Plan for Health Care System Reform: 2009 - 2011 (the Action Plan


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"