New FDA/EU Agreement Creates Safer Drug Supply

The media hub, Eye for Pharma, has reported on the new relaxed rules concerning the export of drugs to the European Union (EU). Additional documentation is no longer required by exporting pharma companies because the US has been granted “listed” country status by the European Commission.

International cooperation is required to ensure that consumers are protected around the world from dangerous medicines. The task is complex. The US Food and Drug Administration has traditionally been an agency that focuses on domestic food and drug policies, but, according to the government agency, this situation is changing. The agency now considers that it is becoming more proactive and involved in global public health issues, which benefits every nation.

The FDA, an agency within the U.S. Department of Health and Human Services, protects public health by overseeing the safety and effectiveness of drugs and other pharma products such as medical equipment. The FDA filed a listing request that would result in US manufacturing processes of drugs being considered equal to those of the EU. Following an audit of the FDA’s practices of ingredient imports, the new status was approved.

Active pharmaceutical ingredients, or APIs, are subject to European regulations and the imports must meet guidelines. The policies aim to ensure the safety of drugs imported from other countries such as the US. Before the approval of listed status, US pharma companies were required to submit FDA documents assuring that the products were manufactured according to the Good Manufacturing Practices (GMP) of the EU. The new ruling is advantageous to the EU because imported drugs can be disseminated more efficiently and at a quicker pace. The US pharma industry benefits from reduced delays and barriers with respect to trade.

The new policies are expected to provide extensive information sharing and harmonization of manufacturing practices throughout global pharma supply chains. The policy aligns with Europe’s Falsified Medicines Directive from 2011, which is designed to protect supply chains as drugs are increasingly provided from worldwide sources.

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