The US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the European Commission have signed a new confidentiality commitment, allowing the FDA to share nonpublic and commercially confidential information, including trade secret information relating to medicine inspections, with European Union (EU) regulators.
“This confidentiality commitment is a milestone in the ongoing implementation of the mutual recognition of inspections of medicine manufacturers, and it aims to strengthen the EU-US relationship. Ultimately it will contribute to a more efficient use of inspection resources by regulators for the protection of human and animal health,” the EMA said in a news release.
The new confidentiality commitment, announced August 23, formally recognizes that the FDA’s EU counterparts have the “authority and demonstrated ability to protect the relevant information,” the EMA said.
Confidentiality arrangements between the EU and the United States have been in place since 2003, allowing for the exchange of confidential information as part of their regulatory and scientific processes. However, complete exchange of information was not possible under these arrangements, the EMA explained.
Under the latest agreement, sharing of full inspection reports will be permitted, “allowing regulators to make decisions based on findings in each other’s inspection reports and to make better use of their inspection resources to focus on manufacturing sites of higher risk,” the EMA said.
Joshua M. Sharfstein, MD, associate dean, Office of Public Health Practice and Training, the Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, told Medscape Medical News, “This is a terrific step forward to facilitate coordination between regulators and reduce redundancy for companies. There are so many companies that are part of the supply chain that it makes sense for the EMA and FDA to be able to share the workload.”
Dr Sharfstein served as principal deputy commissioner at the FDA from 2009 to 2011.
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