US Food and Drug Administration
Medicine inspectors in the European Union will be given access to secret and commercially sensitive information by the Food and Drug Administration (FDA) in the US, after signing a new confidentiality commitment.
Described by the European Medicines Agency (EMA) as a “milestone” in ongoing mutual recognition of inspections of medicine manufacturers, the agreement allows the US regulator to share non-public information relating to medicine inspections with EU regulators.
The new confidentiality commitment formally recognises that the FDA’s EU counterparts have the authority and demonstrated ability to protect the relevant information.
An EMA spokesperson said: “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.
“Ultimately it will contribute to a more efficient use of inspection resources by regulators for the protection of human and animal health.”
Earlier this year, regulators from the EU and the FDA agreed to recognise respective inspections of manufacturing sites for human medicines on either side of the Atlantic in compliance with good manufacturing practice.
Reached following a three-year audit process, the agreement meant that the need for an EU authority to inspect a site in the US, or vice versa would only be needed in exceptional circumstances.
In the EU, inspections of manufacturing sites are carried out by each country’s relevant authority, with the EMA helping to co-ordinate the inspections.
Around 40% of finished medicines sold in the EU come from overseas, and around 80% of manufacturers of constituent ingredients for medicines available in the EU are located outside the EU.
