In late December, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released a draft document for comment that proposes to reduce industry fees – excluding those paid by blood establishments and blood banks – and consolidate the fees into a single set of comprehensive regulations. Comments are due by January 31, 2012.
In the draft, MHRA proposes to: ● reduce decentralized procedure (DCP) fees where the UK is the reference member state (RMS) by 10% ● remove the current differential fee for electronic submissions (eCTD), reducing fees down to the previously lower eCTD level ● simplify the system of periodic fees ● remove 13 individual fee types, and ● simplify parallel import fees by having a single flat fee.
The proposals remove a total of 69 individual fees and provide an overall reduction of 7% in fee costs to industry for 2012.
MHRA explains that one reason for the proposed cuts is to provide industry “a realistic targeted decrease in fees in terms of the recent economic climate.” It notes that the plan builds on the agency’s “strong current position and gives us the resources we expect to need.”
In its request for comments, MHRA emphasizes that “it would be particularly helpful” for firms to “identify and quantify the effects these proposals are likely to have.” It is actively seeking feedback from smaller companies and will contact some of them directly during the consultation period.
While MHRA is proposing fee reductions, FDA is proposing to charge new fees for the review and inspection of generic drugs under its Generic Drug User Fee Act (GDUFA).