Regulatory Focus™ > News Articles > In Last-Minute Decision, EU Says US Companies Clear to Export APIs Under Falsified Medicines Directi

In Last-Minute Decision, EU Says US Companies Clear to Export APIs Under Falsified Medicines Directive

Posted 21 June 2013 | By Alexander Gaffney, RAC

The European Commission has announced that the United States' quality standards are comparable to those of the European Union's, clearing the way for the country's manufacturers to be able to export their active pharmaceutical ingredients (APIs) to the EU without running afoul of the Falsified Medicines Directive (FMD), the terms of which are set to go into effect as of 2 July 2013.


Under the FMD, also known as Directive 2011/62/EU, all entities importing APIs into the EU must meet one of two conditions:

  1. be from a country recognized as having comparable standards to those of the EU
  2. have written confirmation from a recognized local regulator that the API is manufactured in accordance with the EU's current Good Manufacturing Practice (CGMP) standards

Many countries have been scrambling to get their local industries and regulatory authorities into compliance with the law, as EU has made it clear that it will not accept APIs from any entity that does not meet the above conditions.

In recent months, Brazil, China and India have all touted their intent to comply with the second condition, while Switzerland, Australia and Japan have all obtained clearance from the European Commission as having comparable standards to the EU.

Enter: The US

Notably lacking from this list has been the US, long considered to be one of the top global regulatory authorities. With the deadline fast approaching, some industry analysts said they feared drug shortages if US-based suppliers were no longer able to exports their products to the EU.

However, in a 21 June 2013 decision, the European Commission said it would add the US to a list of third countries with "equivalent" levels of regulatory protection to ensure public health.

The notice confirms the US formally requested to be added to the list on 17 January 2013, and that the Commission agreed to the request.

The commission said the finding would come into effect on 26 June 2013-just five days before the 2 July deadline.

In a statement, US Food and Drug Administration (FDA) Commissioner Margaret Hamburg praised the development. "Working with the EC, the FDA has helped US pharmaceutical companies avoid duplicative administrative efforts which impede trade and delay the manufacture of needed medicines," said Hamburg. "At the same time, FDA applauds Europe for taking steps to protect its pharmaceutical supply chain and will continue to collaborate with its regulatory counterparts around the world to help keep our own supply chain safe."

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