13/14 March 2024
The number of GMP inspections requested by the CHMP or CVMP in connection with the assessment of marketing-authorisation applications and/or the assessment of matters referred to these committees in accordance with EU legislation has increased from 420 in the year 2014 to 567 in 2015.
According to the 2015 Annual Report of the European Medicines Agency EMA, which was recently published, the number of these inspections increased by 35% in 2015, linked to the "growing number of centrally authorised products, and due to peak activity in the first quarter related to inspections requested in 2014."
One of these GMP inspections led to a GMP non-compliance statement "preventing the manufacturing site from supplying a centrally authorised medicine in the EU (Inductos)".
By the way, additionally to the centrally organised EMA inspections, the EudraGMDP Database comprises the reports about deficiencies found in inspections by the competent national EU inspectorates including "non-compliance reports" or a "statement of non-compliance with GMP".
And what about the recognition of inspections performed by FDA (and vice versa)?
Here, the TTIP contract might help: "In the framework of the Transatlantic Trade and Investment Partnership (TTIP), EMA continued to support the European Commission and made progress on the mutual reliance of GMP inspections, biosimilars and paediatric medicines."