As discussed within a previous S-cubed article, the European Commission proposed a New Fee Regulation (Regulation (EU) 2024/568) to revise the fees and charges payable to the European Medicines Agency (EMA) for services provided. The New Fee Regulation aimed to simplify the existing fee structure by providing a single framework for a streamlined EMA fee system and to introduce regulatory flexibility for future adjustment to the fee system. This regulation was adopted by the European Parliament and the Council on 7 February 2024 and is applicable as of 1 January 2025.
Summary of main changes
The EMA held a webinar on 24 October 2024 to discuss the New Fee Regulation and the impact on the pharmaceutical industry (see link) with Q&As on fees to be published by the EMA in November 2024. The main changes for the EMA fee structure for regulatory procedures frequently managed by S-cubed are discussed below:
Scientific Advice
As well as reducing the number of fee levels from 6 to 3 levels, with a fee range between EUR 51,900 and 98,400, a revision of the payment method for these high-volume applications has also been introduced. After 1 January 2025, the fees for scientific advice must be paid after validation and before the procedure starts; if no fee is paid the application is cancelled. The 90% fee reduction (100% fee reduction for orphan products) for Small and Medium-sized Enterprises (SMEs) is still in place, but SME status must be valid at the time of submission. An administration fee of EUR 4,400 will be applicable for applications withdrawn after 24 hours of submission, invalid applications or those with an incorrect declaration of entitlement to incentives. The new administrative charges are waived for SMEs.
Paediatric Applications and Orphan Drug Applications
Fees for paediatric applications and orphan drug applications are set out within the New Fee Regulation, however, this is to allow the EMA to renumerate the relevant National Competent Authorities. The fee will be waived in full for applicants and pharmaceutical companies will not receive an invoice. However, an administration fee of EUR 4,400 will be made for applications withdrawn after 24 hours of its submission, invalid applications or those with an incorrect declaration of entitlement to incentives. These administrative charges are waived for SMEs.
Pre-Submission Applications
As well as a fee for an eligibility request, submitted with a notification of intention to submit a Marketing Authorisation Application, the New Fee Regulation introduces an additional fee of EUR 4,200 applicable each time the applicant changes the intended submission date by more than 60 days. There is no SME incentive.
Marketing Authorisation Application
The fees have been simplified for different strengths and presentations, where the fee will cover all strengths, all pharmaceutical forms and all presentations submitted in that application, with different fees for nine different legal categories of medicinal product. An administration fee of EUR 4,400 will be made for applications withdrawn after 24 hours of its submission, invalid applications or those with an incorrect declaration of entitlement to incentives. SME incentives apply and are set out in the working arrangements and related Q&As on the EMA website.
A fee for the re-examination of the opinion issued by the Committee for Medicinal Products for Human Use (CHMP) has been introduced, namely 30% of the fee applicable to the initial opinion. There is no SME incentive.
Variations
There will no longer be a fee for Type I variations as these will be covered within the annual fee for the Marketing Authorisation. Two fee categories have been introduced for Type II variations, with the first (EUR 163,200) for the addition of a new therapeutic indication or modification of an approved indication. The second (EUR 22,000) will apply to all other Type II variations. A SME incentive is in place for both annual fees and Type II variation fees, where a 40% fee reduction applies.
Renewals
There will no longer be a charge for Marketing Authorisation renewal as this will be covered within the annual fee.
Conclusions
The new fees proposed represent an overall hike in the amount that will be paid to the EMA for the regulation of medicines and will have a marked effect on departmental budgets. Timely payment of fees for scientific advice upfront will be necessary to prevent delays to the procedure. The introduction of an administration fee for applications, such as scientific advice, orphan designation and paediatric investigation plans, that are invalidated by the EMA or withdrawn by the Applicant will have an impact on Industry’s approach to EMA submissions with careful preparation required to avoid the fee. When looking to submit a Marketing Authorisation Application, Industry must ensure thorough planning considering the new financial risk associated with changing the date of application and high re-examination fees.
Questions?
We hope you found this article useful. If you have any questions on this topic or need assistance with SME applications to support fee planning for your own programme, please don’t hesitate to get in touch. You can contact us through our website, via email (info@s-cubed.co.uk), or by telephone (S‑cubed Ltd: +44 1235 77 22 60).