As many as 300 API manufacturing sites will need to be inspected to prevent drug shortages after new EU import regulations come into effect this summer according to pan-European group the Heads of Medicines Agency (HMA).
The agency made the prediction at a recent meeting in Dublin, Ireland at which national regulators discussed efforts to identify non-European API manufacturers that – from July – must provide written confirmation of quality in order to ship their products to drugmakers in the European Union.
“The initial mapping was based on information provided by marketing authorisation holders. The mapping work used a smart pdf form which was sent to all NCAs, and which in turn was sent to all the manufacturers in their territory. Each manufacturer entered data that was submitted to a MHRA hosted dedicated database.
“With further data still to be received… approximately 300 sites may require inspection to prevent AS and therefore finished product shortages” the HMA continued, adding that “there are resources available at an EU level for inspections of approximately 25 sites by the end of June 2013.”
The HMA estimate is significantly lower than the 1,200 manufacturing site visits the MHRA suggested may be necessary in December last year when efforts to identify key non-Europe-based API suppliers began, which indicates that drug firms are starting to submit details of their suppliers.
The lower estimate may also reflect the positive impact steps taken in response to the new EU laws – such as the Chinese SFDA’s recently launched survey and the US’ recent request for exemption - have had.
However, despite this, the HMA’s suggestion that there is only enough money available at EU level to fund less around 10% of the 300 visits will exacerbate various national regulators’ concerns that they will end up footing the bill.
The MHRA, for example, has said it has allowed 30 to 40 man days a year for API plant inspections prompted by the new import laws, which works out to around only 10 manufacturing site visits.