The fees payable to the EMA will follow the current legal framework until December 31st, 2024. Then, as of January 1st, 2025, the new fee regulation (EU 2024/568) will be implemented.
In this article, we will detail what this means, in practice, for medicine developers.
What are the aims of the EMA's new fee regulation?
The new regulation has three aims:
- To simplify the current fee system.
- To implement a cost-based system that is proportionate to the work that the EMA puts into different evaluation processes.
- To properly remunerate the member states contributions to evaluating medicines.
The new fee regulation continues to provide incentives to small and medium-sized enterprises (SMEs) and sponsors of orphan medicines, by providing fee reductions.
High-level changes to EMA fees
Some changes worth noting include:
- Removing specific fees including Type 1 variations and renewals.
- Introducing new fees, including pre-submission, referral and re-submission of marketing authorisation applications (MAAs).
- Fee structures calculated for each procedure will reflect the actual costs acquired by the EMA and member states.
- Modifying administrative fees for processes, including application withdrawals and changes to intended submission dates.
- A prepayment system for high-volume applications.
EMA fee changes for pre-approval regulatory deliverables
Scientific advice
The current system includes six basic fee levels (3 for initial and 3 for repeat scientific advice). For small and medium-sized enterprises (SMEs), SME status must be valid by the time the SA procedure begins, but the request for SA can be submitted whilst SME status is still pending.
The new system will include three fee levels without distinction between initial and follow-up advice. SME status must be valid at the time of SA submission. If not, fee incentives will not apply.
Table 1 provides a breakdown of the new scientific advice procedure fees.
Refer to section 1 of Annex 1 of the new fee regulation (EU 2024/568) for more details.
Initial Marketing Authorisation Applications
The current system includes three levels of basic fees but separate fees for additional strengths, forms and presentations. The new system will include nine fee levels, each corresponding to the legal basis a medicinal product falls under. There will no longer be separate fees for additional strengths, forms and presentations.
As with scientific advice procedures, for SMEs to benefit from fee incentives, valid SME status at the time of submission is required.
Re-examination of an MAA
Currently, the EMA does not charge for this service. However, the new system will include a fee of 30% of the initial MAA fee to re-examine an MAA. There will not be any fee incentives attached to a re-examination procedure for SMEs.
Refer to section 4 of Annex 4 of the new fee regulation (EU 2024/568) for more details.
MAA pre-submission regulatory activities
At present, the EMA does not charge for this service. However, the new system will include a pre-submission fee due when submitting the letter of intent. There will also be an additional (and repetitive) fee charged each time the intended submission date is changed by more than 60 days. No SME fee incentives will be attached to MAA pre-submission regulatory activities.
Inspections
Currently, there is no formal communication to market authorisation holders (MAH) regarding the start of an inspection. However, there will be a process for communicating with the MAH about the first day of an inspection. Fees will differ depending on whether the inspection is conducted within or outside of the European Union (EU). Fess will also be applied to inspection cancellations. Fess will differ if an inspection is cancelled before or after 30 days of the first day the inspection is due to occur.
Refer to section 1 of Annex 4 of the new fee regulation (EU 2024/568) for more details.
Annual fees
Currently, there are three levels of annual fees for marketing authorisations and several fee reductions. Moving forward, the annual fee amounts will change, and these changes are detailed in full in Annex 3, section 1 of (EU 2024/568).
Paediatric applications for medicinal products
There are currently no fees applied to paediatric applications. Going forward, different fees will be applied depending on the regulatory activity associated with paediatric development (paediatric investigation plan (PIP); product-specific waiver, compliance check). The fees associated with paediatric regulatory activities will be waived, but the new regulation now details the regulatory rapporteur's remuneration fee.
Refer to sections 11 and 12 of Annex 1 of the new fee regulation (EU 2024/568) for more details.
Table 2 provides a breakdown of the new paediatric development procedure fees.
Orphan applications for medicinal products
Regulatory fee incentives will remain in place for developers of orphan medicinal products (see Table 3). Per the new fee regulation, a fee of EUR 20,000 shall apply for assessing or reassessing an orphan designation. This fee will be waived; however, the new regulation includes a EUR 1900 remuneration charge to the rapporteur.
Refer to sections 11 and 12 of Annex 1 of the new fee regulation (EU 2024/568) for more details.
Table 3 provides a breakdown of fee incentives for regulatory activities relating to orphan medicinal products.
Regulatory fee incentives for Small and Medium sized Enterprises
The EMA’s regulatory fee incentives for SMEs remain largely unchanged. The 90% fee reduction for Scientific advice procedures for SMEs is still valid (100% for orphan medicines developed by SMEs). Additionally, several fee incentives remain in place for SMEs, including a 40% fee reduction (100% fee reduction for micro-enterprises) in the following procedures:
- Extension of an MA
- Major type 2 variations
- Referral procedures
- Certificate of compliance
- Periodic safety update report assessments
- Post-authorisation safety study assessments
- Variations to the terms of an MA
- Annual fees
- Annual pharmacovigilance fees
- Post-marketing surveillance study assessments
- Transfer of MA to another SME
Refer to section 1 of Annex 5 of the new fee regulation (EU 2024/568) for more details on fee incentives specific to SMEs.
Administrative charges for regulatory activities
Per Annex 4 of the new fee regulation, an administrative charge of EUR 4,400 will be applied to all applicants subject to fees applicable to Annexes 1 and 2 of the new fee regulation. This administrative charge will be applied in the following circumstances:
- An application is withdrawn after 24 hours of being submitted and prior to the completion of validation.
- An application has been rejected after concluding validation.
This administrative charge will be enforced for applications for procedures where fees have been waived (SME, orphan, etc).
Refer to section 6 of Annex 4 of the new fee regulation (EU 2024/568) for more details on administrative fees.
The EMA shared a comprehensive webinar detailing the expected changes to its fees as of the 1st of January 2025.
Summary
The new fee regulation sets out several changes to fees applied, application processes and application types. These changes aim to streamline the fee process but also reflect the work that the EMA puts into different evaluations and assessment procedures. For medicine developers, these changes affect the medicinal product type being developed, the stage of development, and the type of corporation engaging in regulatory processes. Therefore, it is important for medicine developers to familiarise themselves with the new fee regulation and its imminent enforcement.
How Somerville Development Partners can help
We have decades of experience navigating regulatory agency interactions and regulatory submissions in Europe and can confidently guide you through your regulatory milestones, including:
- scientific advice interactions,
- paediatric development
- orphan designation and maintenance, and
- the marketing authorization application itself.
We are also a registered SME in Europe.
This means we can access SME benefits and fee incentives on your behalf if your organisation is not established in the European Union (EU)/ European Economic Area (EEA).
