Euro Roundup: MHRA proposed 10% jump in fees, further increases to some services

RoundupsRoundups | 08 September 2022 | By

The UK Medicines and Healthcare products Regulatory Agency (MHRA) would increase all its statutory fees by 10% as part of wider proposals that represent the agency’s most significant shift in fees and funding in years.
 
MHRA proposed a 10% increase in all fees after calculating that the rate is in line with the rise in staff costs – which account for half of the agency’s spending – since it last reviewed its rates in 2016. Costs for other outlays, such as IT, laboratories and accommodation, have grown 21% but MHRA notes that it can absorb those increases via cost reduction programs.
 
The agency also proposes to increase fees above the 10% for 61 services that have seen costs grow even more significantly. MHRA singled out the growing complexity of medical devices and its commitment of additional time to help applicants prepare for assessment as reasons for the larger increases.
 
For example, the proposed fee for “initial application for designation,” which covers both the Approved Body and Notified Body, would rise from £8,252 ($9,429) to £35,672, a jump of more than 330%. The fee for “follow up audit - special clinical” would increase more than 600%, rising from £2,586 today to £18,583 under the proposals.
 
MHRA is also considering creating 22 new fees to address changes in the service it offers since the last rate review. For example, agency seeks to create an £1,800 fee for complex amendments. MHRA plans to keep the new fees under review for 12 months to ensure they recover the costs. MHRA is accepting feedback until 23 November.
 
MHRA Notice
 
Drugmakers call for continuation of COVID flexibilities, more convergence
 
Representatives from AstraZeneca, Gilead Sciences, Moderna and Sanofi have set out their recommendations for the future of regulation in a session at the European Parliament. The leaders discussed the lessons of the COVID-19 pandemic and how the European Union should respond to them.
 
Rudolf Ertl, senior vice president, commercial operations at Gilead, told the politicians how the European Medicines Agency (EMA) accelerated the approval of remdesivir, granting authorization in 70 days, rather than the usual 210 days, by performing a rolling review. The European Commission then reduced its approval from 65 days to eight days. Ertl wants the “spirit of collaboration” to continue.
 
Thomas Triomphe, executive vice president, vaccines at Sanofi, built on the theme, setting out five key lessons from the pandemic. Triomphe, who works at a company that is still striving to bring a COVID-19 vaccine to market, wants EMA to “maintain the regulatory flexibilities and the accelerated pathway until the end of the pandemic” and “facilitate international cooperation and build on regulatory convergence.”
 
“Defining in advance the regulatory agilities in processes at international level will help us manufacturers to design accelerated development plans,” Triomphe said. “We also saw that adoption of digital tools was a very important lever of regulatory agility, for example the use of QR codes for product expiry. This must be further encouraged even beyond the pandemic.”
 
Iskra Reic, executive vice president of Europe and Canada at AstraZeneca, hit similar points, arguing that “it’s very important to have that [rolling review] process in place when there is an urgent unmet need” and that “further harmonization of standards will enable even quicker access.”
 
Meeting Replay, EFPIA Statement
 
EMA’s PRAC starts reviewing neurodevelopmental risks of topiramate
 
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has begun reviewing topiramate based on a study linking the drug to a possible increase in the risk of neurodevelopmental disorders in children whose mothers were taking it during pregnancy.
 
Topiramate is known to increase the risk of birth defects when taken during pregnancy. The risks are currently controlled by a ban on the use of the drug to prevent migraine in people of childbearing potential who are not using highly effective contraception, and by a recommendation that those who are taking topiramate for epilepsy avoid becoming pregnant.
 
PRAC is now looking at whether the EU should impose additional risk-minimization measures based on the study, which linked its use during pregnancy to autism spectrum disorders and intellectual disability in children. The committee also initiated a review of pholcodine medicines.
 
EMA Notice
 
UK, Canada expand GMP mutual recognition agreement to cover overseas inspections
 
The UK and Canada have expanded the mutual recognition agreement they formed in April 2021. As of 1 September 2022, the agreement covers human and veterinary finished products inspections that are conducted in countries outside of the respective parties’ jurisdictions.
 
Officials in the UK and Canada struck the original agreement to prevent Brexit from disrupting trade and allowed regulators to continue to accept each other’s good manufacturing practice (GMP) and batch certificates. However, the agreement was limited to inspections performed in each agency’s jurisdiction, preventing Canada from using MHRA’s overseas assessments and vice versa.
 
Now, officials have expanded the agreement to cover overseas GMP inspections. MHRA said the change “will contribute to reducing the regulatory burden for the importers to obtain information to demonstrate compliance to GMP for their foreign buildings.”
 
MHRA Notice
 
EMA, ECDC form COVID booster policy as rolling review of Comirnaty BA.4/BA.5 starts
 
The European Centre for Disease Prevention and Control (ECDC) and EMA have recommended that the recently approved omicron-specific booster vaccines are used in people who are more at risk of severe COVID-19.
 
EMA’s authorizations allow the use of the Moderna and Pfizer/BioNTech vaccines in people aged 12 years and up but the authorities are recommending targeted deployments. Currently, only BA.1-specific vaccines are available in the EU, but EMA has begun a rolling review of a version of Pfizer’s Comirnaty that is designed to protect against BA.4 and BA.5. Accelerated authorization in the fall is possible.
 
Details of the booster plans emerged alongside the European Directorate for the Quality of Medicines & HealthCare’s (EDQM) update of its guideline on mRNA COVID-19 vaccines. EDQM has revised the text to reflect the recent approvals of the bivalent vaccines.
 
EMA Notice, Commission Plan, EDQM Notice

 

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