Celebrating South Asian Heritage Month at DLRC: Free to Be Me
Published Sep 10, 2024
EMA Updated Fees: What Does This Mean for My Applications?
Published 09th August 2024
A fee payable to the EMA is required for every scientific assessment of a medicinal product related to the application of a marketing authorisation, variation, or authorised product.
January 1, 2025, sees the implementation of EU Regulation 2024/568 on fees for regulatory submissions to the EMA. The legislation will see a significant increase in some of the fees payable to the EMA to support the scientific review of an application.
This article examines the legislation and what this will mean for applications submitted in 2025. Whilst the Legislation applies to both human and veterinary medicinal products, human medicinal products is the focus of this discussion.
Why Are the Fees Changing?
The overhaul of the fees legislation has been driven by the increase in workload at the EMA and the Agencies across the national Member States. Primarily driven by the COVID-19 pandemic and the subsequent initiatives and activities resulting from it, the fee increases are seen to be necessary to ensure the Agencies can continue to fulfil their obligations and commitments.
The regulatory environment is ever-changing. To meet the ever-increasing demands placed on them, sufficient funding needs to be available for the Agencies to maintain an appropriate level of highly skilled expertise and infrastructure, enabling them to deliver the high standards expected for medicinal products intended for the European market.
As a result, the fee structure has been significantly over-hauled. This establishes a single regulatory framework with a streamlined fee system that is flexible enough to be adjusted when required moving forward.
It is worth highlighting that the new fees are “proportionate” instead of the previous “standard” or flat-rate fees.
When Will the New Fees Be Implemented?
The new fee regulation will apply from the 1st of January 2025.
What Are the New Fees?
An example of some of the fees are listed below compared to the currently payable fees. For a full list of fees, please refer to the regulation for further information. – Regulation (EU) 2024/568
| Fee | Current Fee | New Fee |
|---|---|---|
| Marketing Authorisation Application (single strength, one pharmaceutical form, one presentation) | €138,700 (e.g. informed consent [Art 10c Dir 2001/83/EC]) to €357,600 (new active substance [Art 8 (3) Dir 2001/83/EC])) | €172,800 (e.g. informed consent [Art 10c Dir 2001/83/EC]) to €865,200 (new active substance [Art 8 (3) Dir 2001/83/EC])) |
| Extension of a marketing authorisation (level I) | €107,300 | €168,500 to €196,800 |
| Major Variation of type II | €107,300 | Up to €163,200 |
| Annual fee | Up to €128,100 | €60,300 to €232,400 |
What Will This Mean for My Applications?
If you plan to submit your application after 31 December 2024, the fee increase will apply to you. However, if your submission strategy is flexible and you can accelerate your application into 2024, you will make a significant saving. For example, suppose you have a Type II variation planned for submission in January 2025. In that case, you can bring it forward and submit it during December (in line with the submission deadlines), and you can save around 50,000 euros. For a new active substance MAA, the savings would be in the region of 500,000 euros.
Summary
An overhaul of the EMA fees legislation will significantly increase the fees payable for obtaining or maintaining a marketing authorisation from January 2025. However, if your submission strategy is flexible and you can accelerate your application into 2024, significant savings will be made.
Accelerate Your Submissions
If you need support to accelerate your submissions, get in touch. DLRC has extensive experience in successfully supporting regulatory applications from pre-submission interactions through to product approval. Contact DLRC at hello@dlrcgroup.com to find out how our experienced team of regulatory professionals are able to assist you with your regulatory applications.
