We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.
Lexology logo
  Request new password

Search results

Order by most recent / most popular / relevance

Results: 11-20 of 27

China further revises rules for foreign investment in pharmaceutical industry

  • Sidley Austin LLP
  • -
  • China
  • -
  • January 3 2012

On December 24, 2011, China’s National Development & Reform Commission published the amended Industry Catalogue for Foreign Investments

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 releases proposed revisions to China drug distribution regulations

  • Sidley Austin LLP
  • -
  • USA
  • -
  • November 4 2011

On October 14, 2011, the State Food and Drug Administration (SFDA) released another round of proposed revisions to the Administrative Measures for Drug Distribution License (Draft Measures) for public comment by November 30, 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 promulgates device safety monitoring guidance

  • Sidley Austin LLP
  • -
  • China
  • -
  • September 27 2011

On September 16, 2011, the State Administration of Food and Drug (SFDA) unveiled the Tentative Guidance for the Monitoring of Adverse Device Events (Guidance

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 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

Chinese CDE launches joint review for chemical drug and API applications and other life sciences regulatory updates

  • Sidley Austin LLP
  • -
  • China
  • -
  • June 16 2011

The Center for Drug Evaluation (CDE) of the Chinese State Food and Drug Administration (SFDA) released a notice on June 7, 2011, establishing joint review for applications for chemical drugs and their active pharmaceutical ingredients (APIs) with a view to improving drug approval efficiency

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