IPEC e-newsletter - Excipients Insight September 2017 - 19-09-17

 

Inside this issue

     

Strengthening EU-US cooperation in medicine inspections

The US Food and Drug Administration (FDA) has agreed to share full inspection reports with the European Commission and European Medicines Agency (EMA).

The parties have signed a confidentiality commitment that allows the US 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," said the Commission in a statement.

"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 recognises 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.

 

 

 

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