Inspections in countries not expected to confirm API quality or seek exemption from new EU import regs “cannot be seen as a solution” to shortage concerns says the MHRA.
Previously the Heads of Medicines (HMA) – a group comprising representatives from national regulatory bodies – suggested 300 active pharmaceutical ingredients (API) sites will need to be inspected before the new laws come into effect on July 2 to prevent shortages.
in-Pharmatechnologist.com asked the MHRA how the inspections will be funded given that the organisation has previously said it only has capacity for around 10 visits and – according to the HMA – there are only sufficient resources at EU level to support 25 such assessments.
In response the MHRA said that: “APIs are imported into Europe from approximately 1560 sites located in 43 countries. Based on current knowledge we have subtracted those sites that are in countries that have confirmed to provide written statements; are in countries that have applied for or have obtained listing; and hold a valid EU GMP Certificate.
“That currently leaves an estimated 300 API sites that may require inspection. However, this number may reduce when more countries confirm that they will issue written statements or obtain “white listing.”
But, even taking this likely reduction into account, the UK drug regulator is not confident sufficient resources will be available to make all the necessary inspections.
The MHRA told us that: “Based on the latest analysis, inspection of those sites in third countries that are not planning to issue statements or apply for listing cannot be seen as a solution.”
The agency added it is “keeping the situation and the potential implications under review and considering what action may have to be taken to avoid any shortages due to the new legislative requirements,” echoing comments it made late last year .