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Results: 1-10 of 28

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

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

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 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

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 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 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’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 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 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