EMA, FDA Expand Information Sharing for Inspections

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 08-24-2017 14:24


The US Food and Drug Administration (FDA), the European Commission, and the European Medicines Agency (EMA) have signed a new confidentiality commitment that allows US regulators to share non-public and commercially confidential information with regulators from the European Union (EU). This includes trade-secret information relating to medicine inspections.

This confidentiality commitment is part of the ongoing implementation of the mutual recognition of inspections of drug manufacturers, and it aims to strengthen the relationship between the EU and US to provide a more efficient use of inspection resources by regulators.

The EU and the US have had confidentiality arrangements in place since 2003 that have allowed for the exchange of confidential information as part of their regulatory and scientific processes. Complete exchange of information, however, was not possible under these arrangements.

The new confidentiality commitment formally recognizes that the FDA's EU counterparts have the authority and demonstrated ability to protect the relevant information. This step now allows the sharing of full inspection reports to allow 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.

Source: European Medicines Agency


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