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Results: 1-10 of 28

Updates on international pricing issues for pharmaceutical and biologic products

  • Sidley Austin LLP
  • -
  • China, European Union, France, Germany, United Kingdom, USA
  • -
  • May 18 2012

Sidley Austin LLP’s Global Life Sciences Team is pleased to provide you with this Global Pricing Newsletter, the first in a periodic series updating clients and friends of the firm on pricing issues around the world that may have an impact on pharmaceutical and biologic manufacturers’ legal and business strategies

Drug pricing reform: an opportunity and challenge

  • Sidley Austin LLP
  • -
  • China
  • -
  • March 25 2011

The Chinese National Development and Drug Commission ("NDRC"), the authority in charge of drug pricing, recently slashed the maximum retail price of 162 cardiovascular and anti-infective drug products by an average of 21

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

MOH publishes new draft of Drug GSP regulation

  • Sidley Austin LLP
  • -
  • China
  • -
  • May 11 2012

On April 25, the Ministry of Health of China published a new draft of the Drug GSP for public comment, and key changes are:

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 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