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Results: 1-10 of 234

China redefines the authority of its Food, Drug and Device Regulatory Agency

  • Sidley Austin LLP
  • -
  • China
  • -
  • April 16 2013

The Chinese government recently published the final plan to restructure its food, drug and medical device regulatory agency, now named the China Food

China issues judicial interpretations on the application of law in criminal prosecutions involving the manufacturing or sale of counterfeit or inferior drugs

  • Hogan Lovells
  • -
  • China
  • -
  • August 31 2009

On May 27, 2009, the Supreme People’s Court and the Supreme People’s Procuratorate of China issued a set of judicial interpretations to govern certain issues concerning the specific application of law in trying criminal cases involving the production or sale of counterfeit or inferior drugs (the Judicial Interpretations

SFDA issues new rules regulating transfer of drug production technologies

  • Sidley Austin LLP
  • -
  • China
  • -
  • September 1 2009

On August 19, 2009, after nearly two years of deliberation the State Food and Drug Administration of China ("SFDA") issued the Rules for Drug Technology Transfer (the "Rules"), which went into effect the same day

SFDA opens special approval channel for the registration of certain new drugs

  • Hogan Lovells
  • -
  • China
  • -
  • February 24 2009

On January 7, 2009, the State Food and Drug Administration of the PRC (SFDA) issued the Provisions on Special Approval for the Registration of New Drugs

China further opens medical service market to Hong Kong and Macao service providers

  • Hogan Lovells
  • -
  • China
  • -
  • February 24 2009

A set of new provisions that took effect on January 1, 2009 further opens the medical services market in Guangdong Province of the PRC to qualified Hong Kong and Macao service providers

FDA to establish presence in China

  • Drinker Biddle & Reath LLP
  • -
  • China, USA
  • -
  • April 30 2008

The FDA has received approval from the U.S. State Department to establish eight full time permanent FDA positions at U.S. diplomatic posts in the People's Republic of China, pending authorization from the Chinese government

Chinese regulations on medical device advertisements

  • Reed Smith LLP
  • -
  • China
  • -
  • September 21 2009

Effective May 20, 2009, China’s State Administration of Industry and Commerce ("SAIC"), the Ministry of Health (MOH), and the State Food & Drug Administration ("SFDA") jointly issued "Measures for the Examination of Medical Device Advertisements" ("Measures") and "Standards for the Examination and Release of Medical Device Advertisements" ("Standards"), both of which are relevant to medical device manufacturers and distributors advertising medical devices and diagnostic products within China

FDA news

  • Drinker Biddle & Reath LLP
  • -
  • China, USA
  • -
  • April 30 2008

On 10 March, Commissioner Eschenbach announced, after a national search, the appointment of Janet Woodcock, M.D., as the new CDER Director

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

China issues guidelines and 2009-2011 implementation plan on deepening the reform of the healthcare system

  • Reed Smith LLP
  • -
  • China
  • -
  • May 14 2009

On April 6, 2009, the Central Committee of the Communist Party of China ("CCCPC") and the State Council jointly endorsed and issued the Guidelines on Deepening the Reform of the Healthcare System ("Guidelines")1, followed by the Implementation Plan on Focuses for Deepening the Reform of the Healthcare System 2009-2011 issued on April 7, 2009 ("Implementation Plan")2

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