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Results: 1-10 of 30

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 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


MOH publishes new draft of Drug GSP regulation
  • Sidley Austin LLP
  • China
  • May 11 2012

On April 25, the Ministry of Health of China published a new draft of the Drug GSP for public comment, and key changes are:


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


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 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


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 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