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China FDA Proposes Sweeping Rules to Regulate Medical Representatives
  • Sidley Austin LLP
  • China
  • December 28 2017

In January 2017, China's State Council announced that the medical representative (MR) profession would be subject to two new requirements. One

Clinical trials in China
  • Ropes & Gray LLP
  • China, Global
  • October 12 2017

A structured guide to clinical trials in China

A Primer on Dairy Exports to China
  • Hogan Lovells
  • USA, China
  • August 28 2017

U.S. exporters of dairy products to China are subject to importing country listing requirements for manufacturers or processors as a precondition of

New CFDA draft policy introduces patent linkage and "Orange Book" type record
  • Bird & Bird
  • China
  • July 24 2017

On 12 May 2017, the Chinese Food and Drug Administration (CFDA) issued a policy document titled "Policies Regarding the Promotion and Protection of

FDA and CNCA Formalize MOU on Exports of Dairy and Seafood Products to China
  • Venable LLP
  • USA, China
  • July 12 2017

In June, the U.S. Food and Drug Administration (FDA) issued a Memorandum of Understanding (MOU) jointly with the Certification and Accreditation

FDA Signs MOU with China Establishing Registration Process for U.S. Food Manufacturers Exporting Goods to China
  • Keller and Heckman LLP
  • USA, China
  • June 30 2017

As background, China’s General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) supervises and regulates the production of

China Food and Drug Administration Announces Penalties for Clinical Trial Data Integrity Violations
  • Sidley Austin LLP
  • China
  • May 31 2017

On May 24, 2017, the China Food and Drug Administration (CFDA) issued its 2017 Circular No. 63 (the Circular), setting out penalties for clinical

China to Coordinate the Linkage between Patent and Drug Registration
  • AFD China Intellectual Property Law Office
  • China
  • May 24 2017

The Food and Drug Administration of China (CFDA) recently published the draft of Regulations on Promoting Innovation of Drug and Medical Devices and

China's FDA Proposes Patent Linkage Mechanism and Terms for Data Exclusivity for Public Comments
  • LexField Law Offices
  • China
  • May 18 2017

The China Food and Drug Administration on May 12 proposed for the public's comments a draft regulation entitled Relevant Policies for Encouraging

CFDA Further Strengthen the Supervision of Health Food
  • King & Wood Mallesons
  • China
  • May 8 2017

By Mark Schaub and Chen Bing King & Wood Mallesons’ Corporate & Securities group On April 28, 2017, China Food and Drug Administration (“CFDA”