Euro Roundup: MHRA seeks feedback on fee changes intended to ensure ongoing cost recovery

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has proposed five changes to its statutory fees to ensure payments continue to cover the cost of providing services.

MHRA gets most of its income from charging fees for services and sets prices at a level that should recover the cost of the work involved. The agency last updated its fees in April 2023.

Starting April 2025, the agency proposes to increase fees to reflect changes in staff costs and overhead, including maintenance and system investments. MHRA wants to add an indexation of 8.85% to ensure fees cover costs until 2027. The cost of a manufacturing, clinical or pharmacovigilance inspection will rise from £3,651 (US $4,800) to £5,251. Other fees are set to rise by similar amounts.

MHRA also proposes to make targeted changes to its charges for specific services, mainly related to medical devices. The Department for Health and Social Care (DHSC) currently pays for most of MHRA’s work on medical devices, but some activities, such as clinical investigations and auditing approved bodies, are funded by fees.

MHRA proposes replacing the DHSC grant with “a charge to manufacturers who benefit from the post-market work.” The agency said the shift in who funds its activities is “intended to distribute the cost of providing a stable and supportive regulatory environment more equitably across market participants and, therefore, to support competition.”

To do so, MHRA wants to modify the current Medical Device Registration Fee to cover the cost of its post-market activities. MHRA has proposed calculating the fee by “relating staff costs for post-market work to the number of Global Medical Device Nomenclature (GMDN) categories registered to each manufacturer.” The GMDN categories name and group all medical device products.

MHRA proposes charging a £210 annual fee for each GMDN category under which a manufacturer registers. Currently, 44% of suppliers would only need to register for one category. Suppliers with devices registered under more categories may pay up to £280,000 a year. MHRA said it has “evaluated this to be a fair and equitable method.”

While the regulator believes its approach is equitable across most categories, it found “a disproportionate number of GMDN codes to MHRA workload for custom-made dental appliance manufacturers.” In those cases, it proposes charging a single GMDN fee.

MHRA also proposes creating a new service providing regulatory advice meetings for medical devices. The agency will target companies developing novel or complex products “with the potential to significantly improve patient outcomes, where the application of the regulations is not straightforward and easily understood.”

The service, which will cost £987 for a one-hour meeting, is intended to “facilitate an earlier and better understanding of regulatory requirements for the manufacturers of medical devices.” MHRA said it already receives regular requests for such advice but is unable to charge for the service under the current rules, limiting the resources it can commit.

MHRA is accepting feedback on the proposals until 24 October.

MHRA Consultation

Swissmedic makes flurry of changes to data submissions, QR codes and more

The Swiss Agency for Therapeutic Products (Swissmedic) accepts authorization applications for human drugs with new active substances in the SEND (Standard for the Exchange of Nonclinical Data) format as of 1 September. Swissmedic disclosed the change alongside other updates.

Swissmedic said the change “will be particularly useful for applications for which the preclinical data has already been produced in SEND format for submission to the US [Food and Drug Administration.” FDA requires the submission of SEND data for new authorizations.

While Swissmedic will continue to make decisions based primarily on the underlying study reports in PDF format, it said using SEND data “enables effective and efficient analysis of data according to the latest state of science and technology.” The agency updated its guidance to reflect the change.

SEND data is one of three types of information that Swissmedic has begun accepting via the eGov portal. Applicants can also use the portal to send electronic data sets from pivotal bioequivalence studies and to submit drug safety, efficacy and quality films that are viewable via QR codes.

Swissmedic also shared new forms and an information sheet for combined studies submissions and changed its guidance on time limits for authorization applications. Previously, Swissmedic sent a written notification when it accepted an application that had previously been the subject of a formal objection. As explained in its new time limits guidance, Swissmedic will no longer send the notification.

SEND Notice

MHRA shares guidance on pharmacovigilance under revised Brexit agreement

MHRA has published guidance on implementing changes to pharmacovigilance requirements in response to the revised Brexit agreement covering Northern Ireland.

Starting next year, all medicines approved in the UK will be licensed by MHRA. Products that were eligible for authorization by the European Commission in Northern Ireland under the original Brexit deal will be authorized under UK requirements by the MHRA. Some products fall outside the revised agreement's scope and will continue to follow the Commission Implementing Regulation.

MHRA has split the products into two categories based on whether they are authorized under the UK requirements. The guidance defines the two categories and explains the requirements for products in each group. In most cases, companies must submit safety reports to MHRA and the European Medicines Agency. The exception is category 1 products with UK-only licenses.

The guidance also covers the rules on periodic safety update reports, post-authorization safety studies and other topics related to pharmacovigilance. MHRA will implement the changes on 1 January.

MHRA Guidance

EMA publishes ICH guideline on pediatric extrapolation, sets January start date

EMA has published an International Council for Harmonisation (ICH) guideline on using pediatric extrapolation to support the development and authorization of medicines for children.

ICH E11A provides recommendations to promote harmonization of pediatric extrapolation. The goal is to reduce the likelihood of substantial differences between regions, lower children's exposure to unnecessary clinical trials and facilitate more timely access to medicines. The document will take effect in the European Union on 25 January.

In the guideline, ICH refines the extrapolation framework introduced in an earlier document. The three-part framework covers the development of a pediatric extrapolation concept and the creation and execution of a pediatric extrapolation plan.

The guideline explains how to develop a pediatric extrapolation concept, covering the need to understand the factors influencing the disease, drug pharmacology, response to treatment and safety in the reference and target population. Another section addresses how to detail the rationale for proposed studies and data analyses in an extrapolation plan.

ICH Guideline

Euro Roundup: MHRA seeks feedback on fee changes intended to ensure ongoing cost recovery

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