The Medicines and Healthcare Products Regulatory Agency (MHRA) announced the inspection plan earlier today to coincide with the introduction of the Falsified Medicines Directive (FMD) in the UK, which includes regulations designed to ensure the quality of APIs used in drugs sold in the country.
Specifically, the FMD requires importers to obtain written confirmations from competent authorities in non-EEA countries that confirm that the standards of manufacture at API sites on their territory are equivalent to EU Good Manufacturing Practice (GMP). These confirmations must accompany the shipments.
The MHRA said that: “The UK will not control AS import at the border and will instead control at inspection of manufacturers and, where there is a risk trigger, at inspection of AS importers and distributors.”
Shortage concerns
The agency has been one of a number of National regulators to express serious concerns about the new import regulations , which came into effect just last month.
The main worry was that regulators in non-EEA countries would not be able to cope with the additional inspections requirements required by the FMD – they would need to visit manufacturing sites and assess operations before issuing quality confirmations.
In March the MHRA told in-Pharmatechnologist.com that: “300 API sites that may require inspection," and expressed concerns that regulators in importing countries may be forced to conduct the inspections in order to maintain the flow of supplies.
The agency also worried that the import rules would prevent vital drug actives reaching manufacturers in Europe and result in shortages.
This is still a concern for the MHRA, which said today that: “The introduction of these additional [import] requirements may in some instances make the sourcing of API from some third countries difficult.”
The organisation also reiterated its plan to waive the import requirement for certain vital actives that it discussed with us in June.