'Country of Origin' Compliance: The Top 10 Things Pharmaceutical Companies Need to Know

This post was written by Jeffrey Orenstein

What is the “country of origin” for the drugs you manufacture? This question arises every time a pharmaceutical company labels a drug, imports it, exports it, markets it, or sells it to the U.S. government. Unfortunately, the answer to this question is more complicated than many think. In fact, the correct answer often changes, depending on which government agency is asking.

For a Reed Smith-authored white paper on the Top 10 things pharmaceutical companies need to know before determining their products’ country of origin, click here.

Long Delays Still Expected for TSRA License Applications

Reed Smith’s Global Regulatory Enforcement Law Blog recently featured a post about the U.S. Treasury Department’s Office of Foreign Assets Control’s review of applications filed under the Trade Sanctions Reform and Export Enhancement Act of 2000. Although restrictions on the export and re-export of some medical devices and medicines were lifted a year ago, license processing times still remain long, limiting companies’ ability to take advantage of these changes. To learn more about the license applications and potential enforcement actions for non-compliance, read the full alert.

China Life Sciences and Health Industry Client Briefing - October 2012 (November 16, 2012)

This post was written by Jay J. Yan, Hugh T. Scogin, Jr., John J. Tan, Mao Rong, Katherine Yang, May Wong, Amy Yin and Gordon B. Schatz.

Reed Smith’s China Life Sciences and Health Industry Client Briefing provides a summary of the monthly news and legal developments relating to China's Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries.

Some important developments during October include:

  • China Becoming a Healthcare R&D Hub
  • Imported Drugs to Go on China's Electronic Monitoring Network
  • Guangxi to Build Pharmaceuticals as a Pillar Industry
  • China to Set Up Database for Organ Transplants
  • Private Medical Care Gets Boost
  • State Council Issues the 12th FYP for Public Health Services Development

To read the full briefing by Reed Smith China team members, click here.

Life Sciences Health Industry China Briefing - January 2012 (February 13, 2012)

This post was written by Jay J. Yan, Mao Rong, Zack Dong, Katherine Yang, Joyce Sun, Sara Lai and Gordon B. Schatz.

Reed Smith’s Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China's Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries.

Some important developments during January include:

  • Outline of China's Nursing Development Plan from 2011 to 2015
  • Promulgation of Eight Recommended Medical Product Industry Standards
  • Strengthening Implementation of 2010 GMP Amendment
  • Circulation of the 12th Five-Year Plan for Medical Device Technology Industry

To read the full briefing by Reed Smith China team members, click here.
 

U.S. Department of Commerce Seeks Public Comments on Export Controls and International Commerce

This post was written by Leigh T. Hansson and Jason P. Matechak.

On Jan. 5, 2008, the U.S. Department of Commerce Bureau of Industry and Security ("BIS") issued a Request for Public Comments on the effects of U.S. Export Controls on sales of U.S.-origin commercial products and components. Specifically, BIS is seeking public comments on whether U.S. Export Controls influence manufacturers' decisions on whether to use U.S.-origin products and, if export controls do in fact influence sourcing decisions, what the effect is on the U.S. economy as a whole. This is an opportunity for manufacturers and exporters of commercial products to inform the U.S. government as to the economic effects of U.S. Export Controls, and perhaps to have some input into possible reforms of U.S. Export Control law and regulations in the future. Comments are due Feb. 19, 2009.

Attorneys in Reed Smith’s Global Regulatory Enforcement Group are actively monitoring this Request for Comment and are seeking information from life sciences clients facing export controls. Please contact Leigh T. Hansson or Jason P. Matechak if you would like to participate.