Why the EU Centralised Procedure Matters More Than Ever
- Jun 9
- 12 min read
The EU Centralised Procedure (CP) is one of the most powerful mechanisms in global pharmaceutical regulation. A single marketing authorisation application, reviewed by the European Medicines Agency (EMA) and decided by the European Commission, delivers market access across all 27 EU member states simultaneously — plus, through mutual recognition arrangements, in Iceland, Liechtenstein, and Norway. For pharmaceutical and biotechnology companies, it is the most strategically significant approval pathway in Europe, and for the regulatory affairs professionals who navigate it, it represents one of the most complex, demanding, and rewarding areas of practice.
Yet the centralised procedure — and the broader EU pharmaceutical regulatory framework that underpins it — is undergoing its most substantial transformation in over two decades. After years of consultation, political debate, and legislative negotiation, a provisional political agreement on the reform of EU pharmaceutical legislation was reached in December 2025. The rules that have governed EU medicines regulation since Directive 2001/83/EC and Regulation (EC) No 726/2004 are being overhauled. Full implementation is anticipated by 2028. For anyone working in, or aspiring to work in, EU regulatory affairs, this is not background noise — it is the most consequential regulatory reform of a professional lifetime.
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What Is the EU Centralised Procedure — A Foundational Recap
Before examining what is changing, it is worth anchoring the discussion in what the centralised procedure is and why it exists.
Mandatory vs. Optional Scope
The CP is mandatory for certain categories of medicinal products — those whose authorisation would otherwise be fragmented or inconsistent across member states. Mandatory scope currently includes:
- Biotechnology-derived products — medicinal products derived from recombinant DNA technology, monoclonal antibodies, and other advanced biotechnology processes
- Advanced Therapy Medicinal Products (ATMPs) — gene therapies, somatic cell therapies, and tissue-engineered products
- Orphan medicinal products — medicines for rare diseases designated under EU orphan legislation
- Products containing a new active substance for treating HIV/AIDS, cancer, neurodegenerative disorders, diabetes, autoimmune diseases, and viral diseases
Optional scope covers products not in mandatory scope but where a single European assessment would be in the interest of patients or public health — allowing companies to voluntarily opt for the centralised route where it is strategically advantageous.
The Key Players: CHMP, PRAC, CAT, and the European Commission
The centralised procedure operates through a system of scientific committees:
- CHMP (Committee for Medicinal Products for Human Use) — the primary scientific committee that assesses the benefit-risk balance and issues the Committee Opinion
- PRAC (Pharmacovigilance Risk Assessment Committee) — advises on safety issues and post-marketing risk management plans
- CAT (Committee for Advanced Therapies) — provides specialist assessment for ATMPs before CHMP opinion
- COMP (Committee for Orphan Medicinal Products) — maintains orphan designation and advises on criteria for designated products
The European Commission issues the formal marketing authorisation decision, binding across all member states, on the basis of the CHMP opinion. National Competent Authorities (NCAs) implement and enforce the resulting authorisation within their territories.
The December 2025 Legislative Agreement: What Is Actually Changing
The provisional agreement of December 2025 is the culmination of a reform process that began formally with the European Commission's legislative proposals in April 2023. The reform touches virtually every aspect of EU medicines regulation — but several changes have particular significance for centralised marketing authorisations and the professionals who manage them.
1. A New Regulatory Protection Framework: Replacing '8+2(+1)'
The existing system of data exclusivity and market protection — commonly known as the '8+2(+1)' model — has been a fixture of EU pharmaceutical regulation since 2004. Under it, originator companies receive:
- 8 years of data exclusivity — during which generic/biosimilar companies cannot rely on the originator's dossier data
- 2 years of market protection — during which authorised generics/biosimilars cannot be placed on the market
- +1 year extension — available for a new indication with significant clinical benefit
The reform fundamentally restructures this. The new model caps total regulatory protection at 11 years, but makes the actual duration conditional on a company's behaviour and public health contributions. Key features include:
- Base protection of 8 years — but companies must actively launch the product in all EU member states within a defined timeframe to access the full term. Products launched selectively lose protection time in member states where they are not made available — a targeted response to longstanding concerns about access inequalities across EU countries.
- Extensions for clinical innovation — additional protection is available for products addressing unmet medical need, comparative clinical trials, new therapeutic indications, or launching in paediatric populations.
- Reduction for non-launch — companies that do not make products available in all member states within the defined window face reduced protection periods. This is a structural incentive for equitable access built into the authorisation framework itself.
This change has major strategic implications for lifecycle management planning and for the regulatory teams who design and execute post-authorisation strategies. Understanding the new protection architecture is already becoming essential knowledge for regulatory professionals operating in EU markets.
2. The Bolar Exemption: Cleared for Biosimilar and Generic Development
The Bolar exemption — which allows generic and biosimilar companies to conduct regulatory preparatory work (studies, submissions) during the reference product's market protection period — has been significantly strengthened in the reform. This removes a practical barrier that previously slowed the entry of competing products immediately after protection expiry.
For biosimilar regulatory affairs professionals specifically, a stronger Bolar exemption means that development timelines can be compressed and submissions readied while the reference product is still protected — accelerating competition once the window opens.
3. Streamlined Timelines for Marketing Authorisation Assessment
The reform introduces provisions to reduce marketing authorisation assessment timelines, with a focus on administrative efficiency and enhanced use of scientific tools developed since 2004. This includes formalisation of rolling review (previously used flexibly during COVID-19) as a standing instrument — not just an emergency measure.
Rolling review allows the CHMP to assess completed data packages as they become available during development, before a formal marketing authorisation application is submitted. For companies with promising but still-maturing clinical data, this can meaningfully shorten the time from final data lock to authorisation decision.
4. AMR Incentives: Data Exclusivity Vouchers
Antimicrobial resistance (AMR) is one of the defining public health crises of the coming decades, and the EU has long struggled to incentivise the development of new antibiotics, which offer limited commercial returns compared to chronic disease medicines. The reform introduces a novel incentive: transferable exclusivity vouchers for AMR products.
Companies that successfully authorise a qualifying antimicrobial product against priority pathogens will receive a voucher that can be applied to extend the regulatory protection of another product — including one they already hold. This mechanism, modelled partly on the US priority review voucher system, creates a financial incentive for AMR innovation that does not depend on the antimicrobial's own revenue potential.
For regulatory affairs professionals, AMR voucher applications will require careful strategic analysis, complex dossier argumentation, and cross-functional coordination — creating a specialist niche within EU regulatory practice.
5. Conditional Marketing Authorisation: Formalization and Reform
The Conditional Marketing Authorisation (CMA) pathway — which allows approval of promising medicines with less complete clinical data than normally required, subject to post-authorisation confirmatory obligations — has been reformed and formalised under the new legislation.
Previously operating under guidance and precedent rather than explicit legislation, the new framework puts CMAs on a clearer statutory footing with defined criteria, timelines for confirmatory data delivery, and consequences for non-fulfilment. The reform also creates a clearer distinction between CMA (for products where complete data is expected to follow) and the new Authorisation under Exceptional Circumstances route (for products where complete data will never be achievable due to the rarity or nature of the condition).
For regulatory strategists, choosing the right pathway — standard authorisation vs. accelerated assessment vs. CMA vs. Exceptional Circumstances — requires nuanced understanding of the evidentiary requirements, post-authorisation obligations, and lifecycle management implications of each route.
PRIME, Accelerated Assessment, and the EMA's Innovation Tools
Beyond the legislative reform, the EMA has been building its toolkit for supporting innovative medicines through enhanced early interaction and accelerated review:
PRIME (PRIority MEdicines)
The PRIME scheme — launched in 2016 — provides early and enhanced scientific and regulatory support to developers of medicines addressing unmet medical needs. PRIME designation does not shorten the standard 210-day assessment clock, but it delivers:
- Early appointment of a CHMP rapporteur to provide strategic guidance from the outset
- Scientific advice at key development milestones
- An accelerated assessment option (targeting 150 days rather than 210)
The number of PRIME-designated products reaching the market has grown steadily, and the scheme is now a standard element of regulatory strategy discussions for medicines targeting serious conditions with unmet need. Understanding how to make, and benefit from, a PRIME application is an increasingly valued skill.
Accelerated Assessment
Accelerated Assessment reduces the standard CHMP review period from 210 to 150 days for medicines of major public health interest. Combined with rolling review, it represents the fastest route to EU authorisation for innovative products. Regulatory professionals supporting accelerated assessment programmes operate under compressed timelines and must manage regulatory agency interactions with particular precision.
Post-Authorisation Lifecycle: Variations, RMPs, and the IRIS Transition
Receiving a centralised marketing authorisation is not the end of the regulatory journey — it is the beginning of an ongoing lifecycle management obligation that occupies regulatory affairs teams for the entire commercial life of the product.
Variations: The Ongoing Regulatory Workload
Post-authorisation changes to a centralised MA — whether to manufacturing processes, labelling, clinical data, or the terms of the authorisation itself — are managed through the variations framework, governed by Commission Regulation (EC) No 1234/2008 and its subsequent amendments.
The variation classification system distinguishes between:
- Type IA variations — minor changes notified to EMA (e.g., minor administrative updates)
- Type IB variations — changes that require EMA validation but are implemented if no objection is raised within 30 days
- Type II variations — major changes that require full CHMP assessment (e.g., new indications, significant changes to clinical data)
- Extensions of indication / New indications — assessed as near-equivalent to new applications
Managing a complex portfolio of centralised MAs means managing a continuous pipeline of variations — a significant regulatory workload that requires meticulous tracking, procedural knowledge, and cross-functional coordination with manufacturing, clinical, quality, and commercial teams.
Risk Management Plans (RMPs)
All centrally authorised products with a new active substance — and many others — require a Risk Management Plan (RMP): a comprehensive document describing the known and potential risks of the medicine and the measures in place to minimise them. RMPs are living documents, updated throughout the product lifecycle, and must be harmonised with post-marketing pharmacovigilance obligations under Good Pharmacovigilance Practices (GVP).
The interface between regulatory affairs and pharmacovigilance — particularly around RMP maintenance and periodic safety update reports (PSURs) — is one of the most active and demanding areas of centralised MA lifecycle management.
The IRIS Platform Transition: A Practical Priority for MAHs
From December 2024, the EMA began transitioning the management of post-authorisation procedures to the IRIS platform — the agency's centralised electronic management system originally launched for orphan designation procedures. Guide version 3.12 (published January 2026) reflects the current state of this transition.
For Marketing Authorisation Holders (MAHs), the IRIS transition requires:
- Registration in the Organisation Management System (OMS)
- Ensuring all relevant contacts hold active IRIS accounts
- Updating internal processes to align with IRIS submission workflows
- Understanding how IRIS interacts with existing electronic submission tools
This is an immediate, practical regulatory operations challenge — not future policy. Regulatory professionals who are IRIS-fluent are already more valuable than those who are not.
The Post-Brexit Dimension: EU and UK Regulatory Divergence
The UK's departure from the EU means that a centralised EU marketing authorisation no longer covers Great Britain (England, Scotland, and Wales). Northern Ireland remains within the EU's regulatory framework for medicines under the Windsor Framework arrangements — itself a complex regulatory interface.
The practical implications for regulatory professionals are significant:
- Parallel submissions: Companies seeking both EU and UK authorisation must manage parallel regulatory processes under EMA (CHMP) and MHRA respectively, each with their own timelines, dossier requirements, and assessment cultures.
- Divergence risk: As the EU pharmaceutical legislation reform takes effect from 2028, divergence between EU and UK frameworks will increase. Regulatory professionals must track both systems independently.
- MHRA reliance procedures: The MHRA has introduced procedures allowing it to rely on EMA assessments — particularly for international recognition — but these are not automatic. Strategic decisions about sequencing and reliance are required for each programme.
- Northern Ireland's unique position: Products placed on the Northern Ireland market must comply with EU requirements under the Windsor Framework. Managing this interface — especially for centralised products — requires specialist regulatory knowledge.
Career Opportunities: Why EU Regulatory Affairs Is a Growing Field
The combination of the December 2025 legislative reform, the IRIS platform transition, growing ATMP and rare disease pipelines, and post-Brexit complexity is generating sustained, strong demand for EU regulatory affairs expertise. This is one of the most active hiring environments the European pharmaceutical regulatory market has seen.
High-Demand Roles in EU Centralised MA Management
EU Regulatory Affairs Manager- Centralised procedure strategy, submission management, CHMP interactions
Lifecycle Management Specialist- Variations strategy, RMP updates, post-authorisation obligations
Pharmacovigilance Regulatory Lead- PSUR/RMP interface, safety variations, GVP compliance
Regulatory Operations Analyst- IRIS management, eCTD submissions, EMA correspondence
ATMP Regulatory Affairs Specialist- Gene and cell therapy authorisation strategy
Orphan Product Regulatory Manager- Orphan designation, COMP interactions, centralised submissions
Regulatory Intelligence Professional- Tracking legislative reform, guideline updates, precedent analysis
Skills Employers Are Prioritising Right Now
- Deep knowledge of the centralised procedure — 210-day clock, assessment phases, CHMP interaction protocols
- EU variation regulation — classification, procedural types, grouping strategy
- GVP and RMP expertise — particularly GVP Modules V, VI, VII, VIII
- IRIS platform proficiency and eCTD submission experience
- Understanding of EU pharmaceutical legislation reform — the December 2025 agreement and its implementation pathway
- Post-Brexit dual-track (EU/UK) regulatory strategy
- Orphan regulation and ATMP-specific pathways
The Road Ahead: Five Developments to Watch Through 2028
1. Legislative implementation timelines
With full implementation of the December 2025 agreement expected by 2028, regulatory professionals should be tracking the implementing measures, delegated acts, and EMA operational guidance that will translate the political agreement into workable procedures. The detail — not just the headline changes — will determine how the new framework operates in practice.
2. Evolving data exclusivity strategy
Companies and their regulatory teams will need to model the new regulatory protection framework carefully for every pipeline asset. The shift from a fixed '8+2(+1)' structure to a conditional, behaviour-linked protection period changes the strategic calculus for launch sequencing, indication development, and post-authorisation investment decisions.
3. ATMPs: A maturing regulatory frontier
Advanced therapies are among the fastest-growing segments of the centralised procedure pipeline. With complex manufacturing, novel safety profiles, and unique post-marketing requirements, ATMPs represent a specialised and high-growth area of EU regulatory practice — one where demand for experienced professionals significantly exceeds supply.
4. IRIS full operationalisation
As IRIS extends across all post-authorisation procedure types through 2026–2027, MAH teams will need comprehensive IRIS operational competence. Regulatory operations — often seen as a supporting function — will become an increasingly visible and valued capability.
5. AI in EMA assessment processes
The EMA is actively exploring how artificial intelligence tools can support scientific assessment workflows — including literature surveillance, signal detection, and dossier review assistance. As these tools develop, regulatory professionals will need to understand how AI-assisted review changes the assessment dynamic and what it means for submission quality and transparency requirements.
Conclusion: A Framework in Transformation
The EU centralised marketing authorisation is not merely a technical regulatory instrument — it is the gateway to one of the world's largest pharmaceutical markets, the mechanism through which patients across 27 countries access innovative medicines, and the proving ground for some of the most sophisticated regulatory affairs practice anywhere in the world.
It is also, right now, a framework in transformation. The December 2025 legislative agreement, the IRIS transition, the ATMP pipeline expansion, and post-Brexit complexity combine to create a regulatory landscape that demands more from EU regulatory affairs professionals — and rewards expertise, preparedness, and practical competence more generously than at almost any point in the field's history.
For those entering the regulatory profession, or looking to deepen their EU expertise, there has never been a better time to invest in building that knowledge — and never been more urgency to get the foundations right.
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About the Author: Rabiea is an Honorary Associate Professor at UCL, former MHRA Health Authority reviewer, and CEO of Entry to Regulatory and Advanced Regulatory Consulting. After transitioning from retail pharmacy to regulatory affairs, she has dedicated her career to helping others make the same successful career change. Connect with her on LinkedIn for the latest regulatory affairs insights and career advice.
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