Joint inspections are intended to better use resources, allowing for more sites to be monitored and reducing unnecessary duplication. To test the concept EU and US regulatory bodies are seeking companies requesting pre-approval in both regions to participate in a pilot programme.
Applicants to the programme could have their manufacturing facilities jointly inspected by the European Medicines Agency (EMA) and US Food and Drug Administration (FDA). Before this point is reached the regulatory agencies must work through a number of steps.
These include the establishment of contact points, teleconferencing to agree the scope and details of the inspection and deciding which agency will be the lead authority. In the US the FDA leads, in the EU the EMA leads and overseas it is decided on a case-by-case basis.
Preliminary findings will be agreed jointly on site. The lead inspector will contact the company with the final list of any deficiencies and a timeframe in which it should respond. Both authorities will, unless otherwise agreed, issue separate final inspection reports in English.
In the event of a major disagreement on the conclusion of the inspection, a situation the EMA considers to be unlikely, both regulators should continue independently and follow their own procedures.
Sites manufacturing products approved in the EU and US that are anticipating routine re-inspections by both the EMA and FDA at around the same time can also participate in the pilot programme.
The EMA has published an overview of the principles and procedures of the programme. A document with information for applicants, including a submission form, is also available. Applicants can email the form to gmp@ema.europa.eu or CDERInternationalGMP@fda.hhs.gov.