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FDA Signs Agreement with European Medicines Agency on Mutual Recognition of Manufacturing Site Inspection

London, August 28, 2017 — The European Commission (EC), the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) on August 23 announced they have signed a new confidentiality commitment that allows the U.S. regulator to share non-public and commercially confidential information, including trade secret information relating to medicine inspections with 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 EU and the US have had confidentiality arrangements 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 new confidentiality commitment formally recognizes that 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, 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 European Medicines Agency (EMA) is a decentralized agency of the European Union (EU), located in London. It began operating in 1995. The Agency is responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.

EMA protects public and animal health in 28 EU Member States, as well as the countries of the European Economic Area, by ensuring that all medicines available on the EU market are safe, effective and of high quality.

EMA serves a market of over 500 million people living in the EU.