Drug and medical device manufacturers are often faced with difficult challenges in determining the country of origin for their products, which are often sourced, processed and manufactured in multiple countries. As detailed by the article "Origin of the Pieces: How to Determine a Pharmaceutical Product's 'Country of Origin,'" written by Reed Smith lawyers Jeffrey Orenstein and Lorraine Campos, there are a variety of factors that must be taken into consideration when answering the country of origin question for a pharmaceutical product - chief among which is who is asking the question. This article provides an overview of the principal regulatory schemes and their country of origin standards in order to help provide clarity to pharmaceutical companies in an often confusing and frustrating process.… Continue Reading
Every time a pharmaceutical company labels a drug, imports it, exports it, markets it, or sells it to the U.S. government, the company must answer a complicated question: what is the "country of origin"? The correct answer may depend on what government agency is asking.… Continue Reading
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 … Continue Reading
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/ … Continue Reading
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… Continue Reading
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.… Continue Reading