Introduction
The Marketing Authorisation Application (MAA) is one of the most critical regulatory milestones in the development of a medicinal product within the European Union (EU). Through the centralised procedure managed by the European Medicines Agency (EMA), medicine developers must demonstrate the quality, safety, and efficacy of their product to obtain approval for marketing across EU Member States.
As part of the proposed revision to the EU pharmaceutical legislation, several changes are expected to impact how marketing authorisation applications are assessed and managed by the EMA. These reforms aim to modernise the regulatory framework, streamline evaluation timelines, improve medicine accessibility, and create a more agile regulatory environment for innovative therapies.
In this blog, we explore the current EU marketing authorisation framework, examine the proposed legislative changes affecting the MAA process, and discuss what these updates could mean for pharmaceutical and biotechnology companies preparing submissions in Europe.
The revised pharmaceutical legislation
In April 2023, the European Union (EU) undertook a comprehensive evaluation of the pharmaceutical legislation. It adopted a proposal for a new pharmaceutical Directive (2023/0132)1 and a new Regulation (2023/0131)2, which revise and replace the existing general pharmaceutical legislation (Directive 2001/83/EC3 and Regulation (EC) No 726/20044). This evaluation also included a proposal to repeal the existing Orphan Medicinal Products Regulation (EC) No 141/20005, and the Paediatric Regulation (EC) No 1901/20066 and to identify strengths and areas for improvement in a new regulation.
On the 11th of December 2025, the EMA announced that the European Parliament and the Council of the European Union reached a political agreement on the reform of the EU pharmaceutical legislation. It is now undergoing a formal review by the European Parliament and the Council.
To learn more about EU pre-approval regulatory requirements, marketing authorisation applications, and the impact of the revised pharmaceutical legislation on medicine development, watch our webinar: ‘Future-proofing your EU regulatory deliverables and the impact of the revised pharmaceutical legislation on medicine development’.
The Marketing Authorisation Application
The MAA is the total sum of years of drug development, culminating in a dossier that you submit to the EMA. Preparing and submitting your MAA is a significant undertaking, involving a team of 20–30 people preparing the CTD dossier over 18–24 months.
Currently, the EMA’s MAA evaluation procedure takes 210 days, with the European Commission (EC) decision following the CHMP opinion 67 days later. In totality, a new medicine is approved in approximately 277 days in Europe, excluding the clock-stops to provide responses to the CHMP’s questions.
The EMA’s MAA evaluation procedure
Image source: Somerville Development Partners
In addition to drafting the dossier itself, planning your MAA in its entirety should start 2–3 years before you submit it. This is to ensure that you have sufficient time to assemble all the dossier components and gather the required resources for the project.
You must fulfil several needs in the lead up to submitting your MAA, including:
- Determining the legal basis for your MAA
- Determining if your medicinal product is eligible for the centralised procedure
- Submitting an eligibility request and a letter of intent to submit your MAA
- Having rapporteurs and co-rapporteurs assigned from the various committees of the EMA
- Determining the product name suitability with the Naming Review Group
Filing an MAA with the EMA
We have written a blog that explains all of the steps you need to take in the lead-up to submitting an MAA. You can read it here: How to get a drug approved by the EMA.
How will the new pharmaceutical legislation change the EMA structure?
The first thing to note is that the EMA’s five committees will be amalgamated into two. Currently, the EMA is comprised of the following committees:
- Committee for Medicinal Products for Human Use (CHMP)
- Committee for Orphan Medicinal Products (COMP)
- Paediatric Committee (PDCO)
- Committee for Advanced Therapies (CAT)
- Pharmacovigilance Risk Assessment Committee (PRAC)
However, the revised pharmaceutical legislation has proposed that the committees will be reduced to the CHMP and the PRAC as the main committees.1,2
Also, the new pharmaceutical regulation proposes a simpler mandatory scope for medicine approval through the centralised procedure, which will be mandatory for the following products:2*
- medicinal products developed by means of biotechnological processes
- advanced therapy medicinal products
- any medicinal product that includes a new active substance which was not authorised in the Union at the date of application of the new regulation
- new active substances not covered by the previous point and which are developed for the treatment of acquired immune deficiency syndrome, cancer, neurodegenerative disorder, diabetes, auto-immune diseases and other immune dysfunctions, viral diseases.
- orphan medicinal products
- medicinal products authorised in accordance with a paediatric use marketing authorisation
- priority antimicrobials
*Updated text compared to the current pharmaceutical legislation in italics
How will the new pharmaceutical legislation change how the EMA evaluates an MAA?
Currently, the CHMP evaluates new medicines under the centralised procedure within 210 days. A final decision by the EC is then given 67 days after the CHMP opinion. However, the new pharmaceutical legislation proposed to shorten this evaluation period to 180 days and the final EC decision within 46 days, essentially streamlining medicine approval by 2 months.1,2
Article 6 of the revised regulation also highlights the possibility of a ‘phased review’ for “medicinal products which: 2*
- are likely to address an unmet medical need as referred to in Article 83(1) of [revised Directive 2001/83/EC]1 and are expected to be of major interest from the point of view of public health, in particular as regards therapeutic innovation; or
- are antimicrobials with any of the characteristics mentioned in Article 40(3) or provided for in the ‘WHO priority pathogens list for R&D of new antibiotics’, specifically those listed as priority 1 (critical) or priority 2 (high), or taking into account as a priority any equivalent list of priority pathogens adopted at Union level; or
- are intended to be used in relation to a potential or recognized public health emergency.
*Updated text compared to the current pharmaceutical legislation in italics
Summary
The proposed revision to the EU pharmaceutical legislation is expected to introduce important changes to the marketing authorisation process and the way the EMA evaluates medicinal products through the centralised procedure. Updates to assessment timelines, regulatory requirements, and procedural frameworks could significantly influence submission planning and regulatory strategy for pharmaceutical and biotechnology companies.
For medicine developers, understanding these upcoming changes will be essential for preparing robust and efficient marketing authorisation applications within an evolving EU regulatory landscape.
How Somerville Development Partners can help
Our team brings decades of combined experience across both consultancy and industry settings. This dual perspective enables us to balance regulatory rigour with scientific and operational realities.
We don’t just advise, we embed within your team to deliver high-quality regulatory solutions to help pharmaceutical and biotech companies develop safe and efficacious medicines for patients.
We can support every aspect of the MAA preparation and filing, including:
- Developing a Common Technical Document (CTD) table of contents for the submission and conducting a gap analysis to ensure that all submission components have been identified and planned.
- Preparing key messaging and the company core data sheet.
- Preparing regional labelling such as the Summary of Product Characteristics and US Prescribing Information.
- Planning the data presentation, analysis and discussion in the dossier.
- Conducting detailed reviews of the data (tables, figures and listings) shells to ensure the required analysis and outputs are planned.
- Writing Modules 1–5 of the electronic CTD.
- Publishing and submitting the completed submission.
- Responding to questions from the agency during the evaluation.
- We frequently, work as part of the global filing team for parallel submission to the US, EU and additional authorities. If possible, it is worthwhile writing a submission with common US and EU Module 2–5 components, especially the Module 2 summaries, so that multiple consistent submissions can be made to streamline regulatory agency interactions.
- We can also provide peer review of existing projects, to stress-test the work that has been done and recommend solutions to address any gaps. Peer review may be especially useful to prepare for the MAA submission, where an additional perspective may help to highlight any potential risks.
