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Expanded FDA Electronic System Now Includes All Exports Lists
  • Keller and Heckman LLP
  • USA, China
  • July 10 2018

The U.S. Food and Drug Authority (FDA) announced the launch of an electronic portal, Export Listing Module (ELM), for receiving and processing

International Life Sciences Review: Issue 8
  • Morgan Lewis
  • USA, Netherlands, China, European Union, France, Global
  • February 6 2018

The European Commission has published the Draft Regulation amending Regulation (EC) No 8472000 as regards the definition of the concept 'similar

Trade Secrets Protection Reinforced
  • HFG Law & Intellectual Property
  • USA, Australia, China
  • January 31 2018

On January 1st, 2018, the new Amendment to the PRC Anti-Unfair Competition Law (the "Amended AUCL") has entered into force. AUCL has always been a

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

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