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Results: 1-10 of 30

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 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


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 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


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 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 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


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