EMA and FDA to Begin Sharing Commercially Confidential Information

Posted 23 August 2017 By Zachary Brennan

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Editor's note: this article has been updated with a statement from FDA clarifying that the agency must sign a confidentiality agreement with each EU country before unredacted inspection reports may be shared.

As part of a landmark agreement forged in March, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) said Wednesday that they will soon share non-public and commercially confidential information, including trade secret information.

The announcement is part of the implementation of an agreement between FDA and EMA to mutually recognize one another's pharmaceutical manufacturing inspections, which will likely reduce duplicative inspections and lower costs for both regulators.

According to the commitment signed by Dara Corrigan, FDA's acting deputy commissioner for global regulatory operations and policy, FDA says it will protect from public disclosure such non-public information.

And in the agreement signed by EMA Executive Director Guido Rasi, EMA may share some information received from FDA with the European Commission's Directorate-General for Health and Food Safety (DG SANTE), as well as representatives of EU member state regulators. FDA will advise the Commission and EMA of the non-public status of such information when it is shared.

EMA said the agreement allows for the sharing of full inspection reports, meaning both regulators can make decisions based on findings in each other's inspection reports and make better use of resources to focus on manufacturing sites of higher risk.

But, before FDA can share unredacted inspection reports with EU member states' inspectorates, the agency says it "must sign a similar confidentiality commitment with each EU country."

FDA says it anticipates these agreements can be made "expeditiously" using the agreement with EMA and DG SANTE as a template and says it will be initiating negotiations for those agreements with each EU member state.

EMA

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Categories: Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Regulatory strategy, News, US, Europe, FDA, EMA, EC

Tags: EMA and FDA agreement, mutual recognition agreement, GMP inspection reports

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