Posts Tagged ‘European Union’

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Opportunity for U.S. Manufacturers of Active Pharmaceutical Ingredients

October 22, 2013

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Farah Naim is an International Trade Specialist in the International Trade Administration’s Office of Health and Consumer Goods.

The European Union (EU) is taking action against substandard and falsified medicines, and it could present an opportunity for U.S. pharmaceutical manufacturers to increase exports to the region.

As of July 2, shipments to any EU country of active pharmaceutical ingredients (APIs) — the ingredients that make medications work — have had to be certified by the EU. Certification requires that the APIs be manufactured under standards at least equivalent to EU manufacturing practices. These standards include considerations for quality management, production reviews, and regular internal audits of manufacturing facilities.

Each individual pharmaceutical manufacturing facility now needs a compliance certificate for every API that it produces.

Countries can request assessment of their national manufacturing standards, to determine if they meet the EU’s standard. If they do, then individual manufacturers in those countries will not need a compliance certificate. As of September, Australia, Japan, Switzerland, and the United States have applied for and met the standard.

This presents an opportunity for U.S. innovative and generic pharmaceutical manufacturers. As global manufacturers apply for EU certification, and other nations apply for and strive toward EU standards, American-made pharmaceuticals can fill gaps created by the certification processes.

All of us here on ITA’s Health Team are dedicated to enhancing the global competitiveness of the U.S. health industry, and making sure it has every advantage when competing abroad.

For more information on this and other health-related trade matters, please visit ITA’s Health Industries page or contact me at Farah.Naim@trade.gov.

More information on the new rules, enacted in Directive 2011/62/EU, can be found at: http://ec.europa.eu/health/human-use/quality/index_en.htm.

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President Obama Prescribes Increase in U.S. Exports to Support Economic Growth

February 13, 2013

Francisco Sánchez serves as the Under Secretary of Commerce for International Trade. 

Archived photo showing Congress during 2011 State of the Union Address.President Obama made it clear in his State of the Union address that American exports will play a part in America’s economic success. This requires creating free access for American goods to more markets, enforcing trade laws, and ensuring a level playing field in which American companies can compete.

These initiatives have and will continue to support business and create jobs. Over the last 35 months, they’ve already contributed to the creation of 6.1 million private-sector jobs. We at the International Trade Administration are proud to be a part of that success and we know that continuing these initiatives will lead to further economic growth.

The President specifically mentioned completing the Trans-Pacific Partnership and entering into a trade agreement with the European Union. Trade agreements like these proved effective in 2012, when we set a new record for U.S. exports. Recently released data show that almost half of the growth in U.S. exports in 2012 was to countries with which we have similar agreements. In fact, U.S. exports to the 20 countries with which we have trade agreements comprised almost half of American goods exports in 2012.

We achieved record levels of exports to 11 of our trade agreement partners in 2012. Five of them – Australia, Canada, Chile, Mexico and Peru – will all be a part of the TPP and accounted for more than $550 billion in U.S. exports. Completing this partnership will further develop our trade with these countries and help our exports continue to grow.

As Deputy Secretary of Commerce Rebecca Blank explained today, a trade agreement with the EU “will support good-paying American jobs and will expand our trade and investment relations, strengthen our economy, and create new opportunities on both sides of the Atlantic.”

President Obama also mentioned the importance of enforcing trade regulations and ensuring a level playing field in which American exporters can compete. We accomplish this mission every day at ITA, and we are proud to help American exporters compete as a lead member of the President’s Interagency Trade Enforcement Center.

The President has set a clear path to use export growth to help grow the American economy. We at the International Trade Administration are ready to do what it takes to continue to support President Obama’s mission and help support a thriving American economy.

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Help Make Exporting To the European Union Easier – Seeking Comments on US-EU Regulatory Cooperation

July 11, 2011

Have you experienced challenges in exporting to the European Union (EU)?  Do you have any ideas for making it easier to export to the EU by enhancing U.S.-EU regulatory cooperation?  If so, we want to hear from you.  In response to requests for additional time to provide comments, the Department of Commerce has reopened the comment period for its Federal Register Notice, “Request for Public Comments Concerning Regulatory Cooperation between the United States and the European Union That Would Help Eliminate or Reduce Unnecessary Divergences in Regulation and in Standards Used in Regulation That Impede U.S. Exports”.

The United States Department of Commerce strives to eliminate differences in regulatory measures between the U.S. and the EU, while also promoting free and open trade as well as protecting public health and safety, the environment, intellectual property, and consumers’ rights. The Federal Register Notice is a medium where all associations, business, and individuals in U.S. and EU countries can voice their challenges and recommendations regarding regulatory divergences.  Your comments are important in assisting us to increase awareness of trade impediments and improve exporting between the U.S. and EU.

The new deadline for comments is August 8, 2011.

Comments may be submitted electronically via Regulations.gov.  You may also access the Docket Folder, where you can read comments that have already been submitted (check the box labeled “Public Submission”). While we appreciate and encourage discussion here on our blog, the only way to ensure consideration of your input is to submit comments through the form on Regulations.gov.

Please direct any questions to TransatlanticRegulatoryCooperation@trade.gov

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