UK Regulator Plans New & Higher Fees To Ensure Financial Sustainability
Industry Charges Have Not Been Reviewed Since Brexit
The MHRA says pharmaceutical and medical device companies should be confident that planned changes to the fees structure will guarantee them “the high-quality service they expect.”
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The Medicines and Healthcare products Regulatory Agency says that the fee increases to be introduced on 1 April, along with 18 new fees, are necessary for its long-term financial sustainability and its ability to provide a “responsive, innovative and efficient regulatory service.”
The European Medicines Agency says that the current shortage of antibiotics containing amoxicillin is not a “major event” and that efforts by EU and national regulators are helping to mitigate the situation.
From next year, more agencies will be involved in the UK’s regulatory reliance procedure for new drug approvals, which was first introduced in 2021 to allay fears of post-Brexit delays to UK applications. The pharmaceutical industry said it looked forward to working with the regulator on the new framework.