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Results: 1-10 of 30

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


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On August 1, 2012, the Ministry of Health of China (“MOH”) issued the draft Guidance on Strengthening Anti-Bribery Control at Public Hospitals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 proposes new ADR reporting rule
  • Sidley Austin LLP
  • China
  • July 30 2009

On June 30, the Ministry of Health ("MOH") and the State Food and Drug Administration ("SFDA") of China issued a draft revision of the Rule on Adverse Drug Reaction Reporting and Monitoring (the "Reporting Rule"


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"


China promulgates new ADR reporting rules
  • Sidley Austin LLP
  • China
  • June 2 2011

On May 24, 2011, the Ministry of Health ("MOH") issued the revised Rules on Adverse Drug Reaction Reporting and Monitoring (the "Reporting Rules"), 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 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


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 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