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Results: 1-10 of 30

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


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 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 issues new rule on medical device advertisements
  • Sidley Austin LLP
  • China
  • June 5 2009

On May 13, the Ministry of Health (MOH), the State Administration of Industry and Commerce (SAIC) and the State Food and Drug Administration (SFDA) of China jointly issued an amended Rule for Review of Medical Device Advertisements (the Rule) and accompanying Standards for Review of Medical Device Advertisements (the Standards), both of which went into effect on May 20


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’s comprehensive health care reform plan: implications for pharmaceutical and device firms
  • Sidley Austin LLP
  • China
  • April 9 2009

On April 6, the State Council of China made public the Guideline on Further Reforming the Health Care System (the Guideline), and on the following day the Action Plan for Health Care System Reform: 2009 - 2011 (the Action Plan


China proposes new drug GMPs, significantly raising standards
  • Sidley Austin LLP
  • China
  • October 28 2009

On September 23, the State Food and Drug Administration of China ("SFDA") published a draft of revised drug good manufacturing practices ("GMP") for public comments ("GMP 2009"


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"


New PRC Tort Law offers clarification on medical product liability, remains silent on top industry concerns
  • Sidley Austin LLP
  • China
  • January 29 2010

After eight years of deliberation and four rounds of revisions, the Tort Law of the People's Republic of China (the Tort Law) was adopted by the Standing Committee of the National People's Congress on December 26, 2009 and will become effective on July 1, 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