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
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
Numerous signals by the Food and Drug Administration ("FDA") in recent weeks, including statements made by Dr. Margaret A. Hamburg, the recently appointed FDA Commissioner, show that the agency intends to toughen enforcement in several areas. These signals should be taken seriously. An "awakened" FDA will be funded with additional monies promised for FDA's budget and with funding proposed through legislation such as The Drug and Device Accountability Act of 2009 (S. 882). As a result, firms that manufacture, import, and distribute FDA-regulated products can anticipate being visited more often, and probably more critically, than in the past. This, in turn, will force a company to handle additional Inspectional Observations (FDA 483s), Warning Letters, and reinforcement actions.… Continue Reading