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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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