FDA Details Strategies for Addressing Globalization - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

FDA Details Strategies for Addressing Globalization
A new report by FDA details the strategies, programs, and other activities the agency is using to address the rise of imported pharmaceutical products and APIs.


ePT--the Electronic Newsletter of Pharmaceutical Technology

FDA issued a new report this week that details the activities that the agency is using to address the increased globalization of the industries that it regulates, including pharmaceuticals.

“As our world transforms and becomes increasingly globalized, we must come together in new, unprecedented, even unexpected, ways to build a public health safety net for consumers around the world,” said FDA Commissioner Margaret A. Hamburg, MD, in an Apr. 23, 2012, FDA press release.

Since 2002, imports of pharmaceuticals products and biologics have more than doubled, according to the FDA report, Global Engagement. Foreign-sourced pharmaceuticals now account for approximately 40% of the drugs consumed in the United States, and 80% of APIs in US-consumed drugs are sourced from abroad.

The report outlines a variety of engagement strategies FDA is using in partnership with other agencies, organizations, and coalitions around the world to strengthen global regulatory capacity-building efforts, develop and harmonize science-based regulatory standards, increase awareness about the importance of regulatory systems, and share information and data globally to facilitate rapid identification of and response to public health emergencies.

Part of FDA’s strategy has been to open international offices to increase the agency’s overseas presence. As of 2011, FDA has posts in China (Beijing, Shanghai, and Guangzhou), India (New Delhi and Mumbai), Latin America (San Jose, Costa Rica; Santiago, Chile; and Mexico City, Mexico), Europe (Brussels, London, and Parma, Italy), South Africa (Pretoria), and the Middle East and North Africa (Amman, Jordan).

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
How does your company apply quality-by-design (QbD) principles to manufacturing processes?
To all processes for both new and legacy products
To all process for new products only
To select process for new products only
To select processes for both new and legacy products
Do not use QbD
To all processes for both new and legacy products
20%
To all process for new products only
13%
To select process for new products only
24%
To select processes for both new and legacy products
20%
Do not use QbD
22%
View Results
UPCOMING CONFERENCES

Programs for Investigational and Pre-Launch Drugs
Philadelphia, PA
July 17-18, 2013
Request Brochure

Strategic Pipeline Planning & Portfolio Valuation
Philadelphia, PA
August 13-14, 2013
Request Brochure

MES 2013 - Forum on Manufacturing Execution Systems
Philadelphia, PA
August 14-15, 2013
Request Brochure

Mobile Innovation for the Life Sciences Industry
Philadelphia, PA
August 20-21, 2013
Request Brochure

See All Conferences >>

Eric Langer Outsourcing Outlook Eric LangerOutsourcing's Modest Role as a Cost-Containment Strategy
Patricia Van Arnum Ingredients Insider Patricia Van ArnumIntellectual Property Battles in Solid-State Chemistry
Nathan Jessop Industry Insider Nathan Jessop Campaign Against Counterfeit Drugs Continues
Lynn Torbeck Statistical Solutions Lynn D. TorbeckCompositing Samples and the Risk to Product Quality
 More
Inadequate Access to Medicines Puts EU at Risk
FDA Offers Insight on QbD for Modified-Release Products
Global Biosimilars Market to Reach $2.445 Billion in 2013
Adapting to Change
AstraZeneca and Exco InTouch Collaborate to Augment Current COPD Pathways
FindPharma Custom Search
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here