“Regulators in the European Union (EU) and the United States (US) have agreed to recognise inspections of manufacturing sites for human medicines conducted in their respective territories on both sides of the Atlantic.”
Under the New Confidentiality Agreement signed in in August 2017, the FDA is allowed to share full inspection reports of medicine manufacturers, including non-public and commercially confidential information, and trade secret information relating to medicine inspections with EU regulators.
This confidentiality commitment is part of the ongoing process of the mutual recognition of inspections of medicine manufacturers, aimed to encourage greater international harmonisation, make better use of inspection capacity and reduce duplication.
The European Union (EU) and the United States (US) have also signed a mutual recognition agreement (MRA) on good manufacturing practice (GMP) inspections which enters into force on 1 November 2017 and will be in transition phase until July 2019.
This allows the EU or FDA to make decisions based on findings in each other’s inspection reports. The need for the EU authority to inspect a site located in the US, or vice versa, will be limited to exceptional circumstances and allowing them to focus on manufacturing sites of higher risk.
This agreement will now help the EU or FDA to focus on other parts of the world where active pharmaceutical ingredients (APIs) and medicines for the EU or US markets are manufactured, ensuring that patients can rely on the quality, safety and efficacy of all medicines, no matter where they have been produced.
Of particular note is that UK’s MHRA and the US FDA have qualified each other’s inspections through a series of joint / observed inspections.
“The EU already has experience with mutual recognition of GMP inspections, having existing MRAs of GMP inspections already for several other countries including Australia, New Zealand, Canada, Japan and Switzerland.”
WBR has assisted companies to achieve excellent results in their FDA and EU inspections at sites around the world so if you have any questions or would like to find out more please call us on +44 (0)1484 434343 or email to email@example.com