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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"


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On August 1, 2012, the Ministry of Health of China (“MOH”) issued the draft Guidance on Strengthening Anti-Bribery Control at Public Hospitals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


SFDA’s working plan for the year of tiger
  • Sidley Austin LLP
  • China
  • February 16 2010

On January 19, 2010, officials from the State Food and Drug Administration (SFDA) and its local counterparts gathered together in Beijing to attend the 2010 National Conference on the Food and Drug Administration


China heightens crackdown on commercial bribery in pharmaceutical industry
  • Sidley Austin LLP
  • China
  • July 7 2010

On June 21, 2010, the Ministry of Health of China (MOH) published a notice in which it identifies key measures that local health authorities are required to take to crack down on commercial bribery in the pharmaceutical industry (the “Notice”


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


Commercial bribery enforcement in the healthcare industry: what’s next?
  • Sidley Austin LLP
  • China
  • January 19 2011

In 2010,we witnessed an increasing number of enforcement actions taken by the local Administrations for Industry and Commerce ("AIC") in China against sales and promotional activities undertaken by healthcare companies, alleging commercial bribery