Bringing a new therapy to market in the European Union requires years of work across research, development, and compliance.
The final step before patients can access that product is the Marketing Authorisation Application (MAA). This submission is where sponsors present all evidence of a product’s safety, efficacy, and quality to regulators.
Understanding how the process works and how to manage it efficiently can determine whether a company meets its approval timelines or faces costly delays.
A Marketing Authorisation Application, or MAA, is the formal request to place a medicinal product on the market in the European Union. It is the moment when years of clinical research, manufacturing control, and regulatory planning converge into a single submission package for review by the European Medicines Agency (EMA) or national regulatory authorities.
The goal of the MAA is to demonstrate that a product is consistently manufactured, clinically effective, and safe for patient use. While similar to the New Drug Application (NDA) in the United States, the MAA process is governed by a distinct framework that reflects the EU’s shared regulatory model. Sponsors must provide comprehensive data from nonclinical and clinical studies, as well as detailed descriptions of their manufacturing processes, facilities, and quality management systems.
An approved MAA results in a Marketing Authorisation, which allows the product to be sold and prescribed throughout the applicable EU markets. Depending on the submission pathway, this may cover all member states through the centralized procedure, or specific countries under decentralized or mutual recognition routes.
For sponsors, preparing an MAA is both a scientific and logistical challenge. Every document must be traceable, every dataset consistent, and every version controlled. The submission becomes the definitive regulatory record of the product. This is why teams increasingly rely on validated document management systems to ensure accuracy and compliance across every module of the Common Technical Document (CTD).
The Marketing Authorisation Application is more than a regulatory requirement. It is the formal bridge between development and commercialization in the European Union. The ultimate goal is to secure a Marketing Authorisation that confirms the product’s safety, efficacy, and quality, allowing it to be made available to patients.
From a regulatory perspective, the MAA ensures that no medicinal product reaches the market without a thorough review of its benefit–risk profile. It gives authorities confidence that the sponsor’s data is complete, traceable, and aligned with Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP) standards.
From a business perspective, a successful MAA submission validates the years of investment in research, development, and manufacturing infrastructure. It marks a company’s transition from a clinical-stage organization to a commercial one. For emerging biotech and specialty pharma teams, this milestone can open doors to new markets, partnerships, and funding opportunities.
However, reaching that point requires complete alignment across regulatory, clinical, and quality functions. The accuracy of one module depends on the consistency of all the others. Any disconnect between departments can lead to data discrepancies, validation questions, or delays in the review timeline.
That is why many sponsors now structure their development and submission workflows around a unified document management system. When every team works from the same source of truth, the MAA becomes not only a regulatory achievement but a demonstration of operational maturity.
A Marketing Authorisation Application is required whenever a sponsor seeks to place a medicinal product on the market within the European Union or European Economic Area. Whether the product is an innovative therapy, a biosimilar, or a generic, the sponsor must obtain marketing authorization before it can be sold, prescribed, or distributed to patients.
MAAs apply across a range of product types, including:
New active substances that have never been approved in the EU.
Generics that reference a previously authorized product.
Biosimilars that demonstrate comparability to an existing biologic.
Advanced therapy medicinal products (ATMPs) such as gene, cell, or tissue-based therapies.
Hybrid or fixed-dose combination products, which combine existing substances in new forms or indications.
The route a sponsor takes depends on the product category, the company’s commercial strategy, and the markets where approval is sought. The European regulatory system offers four main pathways for MAA submissions: centralized, decentralized, mutual recognition, and national.
Each pathway has specific eligibility criteria and review structures, but all require the same core dossier built in the Common Technical Document (CTD) format. Regardless of pathway, the expectation from regulators is clear: data integrity, complete documentation, and traceability from clinical development through manufacturing.
For emerging biotechs and mid-sized pharma teams, choosing the correct submission route early can save months of preparation time and reduce the risk of redundant documentation. Centralizing regulatory content within a single validated system allows sponsors to adapt their submissions efficiently as market strategies evolve.
There are four primary pathways through which a Marketing Authorisation Application can be submitted in the European Union. Each route is designed for different product types and market goals, but all lead to the same outcome: regulatory review and, if successful, a Marketing Authorisation that enables patient access.
The centralized procedure provides a single, EU-wide marketing authorization that allows a product to be sold in all EU and EEA member states through one regulatory submission and one evaluation process. It is coordinated by the European Medicines Agency (EMA) and results in a single decision from the European Commission that is valid across the entire region.
This route is mandatory for certain categories of products, including:
It is also optional for other innovative products that represent significant scientific or therapeutic advances, or that would benefit from a centralized review due to their potential to improve public health outcomes across the EU.
Sponsors submit their application to the EMA, where the Committee for Medicinal Products for Human Use (CHMP) performs the primary scientific evaluation. If the CHMP adopts a positive opinion, the recommendation is sent to the European Commission, which grants the final authorization.
For sponsors, the centralized procedure offers major advantages in terms of efficiency and market access — a single approval, consistent labeling, and harmonized post-authorization requirements across all member states. However, it also demands exceptional dossier quality, complete data traceability, and well-coordinated communication between regulatory, quality, and clinical teams to navigate the EMA's structured review process.
The decentralized procedure applies when a product has not yet received authorization in any EU member state and the sponsor wants approval in multiple markets simultaneously. One country acts as the Reference Member State (RMS), performing the primary evaluation, while other Concerned Member States (CMS) review and adopt the decision.
DCPs require strong collaboration between national authorities and clear documentation alignment to prevent divergent assessments. Using a single document management platform for all participating countries helps sponsors manage updates and responses efficiently.
The mutual recognition procedure allows a sponsor to extend an existing national authorization from one member state to others. It is typically used for established products that are already authorized in at least one EU country.
This pathway can accelerate market expansion, but success depends on maintaining a complete and consistent dossier across jurisdictions. Variations in national requirements or document versions can trigger delays or additional rounds of questions.
The national procedure is used when a sponsor seeks authorization in a single EU member state only. It is often chosen for early-stage launches or niche products with a limited market scope.
While simpler in scope, national procedures still require full CTD documentation and adherence to the same quality and pharmacovigilance standards expected under broader routes.
Each of these pathways demands meticulous document control, transparent communication, and readiness for regulatory questions. Sponsors who prepare their submissions within a unified document management system can more easily adapt to changing requirements and scale across multiple markets.
Every Marketing Authorisation Application must follow the Common Technical Document (CTD) format, a globally harmonized structure developed by the International Council for Harmonisation (ICH). The CTD standardizes how sponsors present nonclinical, clinical, and manufacturing data, allowing regulators to review submissions consistently across regions.
The CTD is divided into five modules:
This module includes region-specific administrative documents, product information, application forms, and proposed labeling. In the EU, it covers the summary of product characteristics (SmPC), package leaflet, and mock-ups of outer packaging.
This section provides high-level summaries of the quality, nonclinical, and clinical data. It helps assessors understand the overall development strategy and key findings before reviewing the detailed technical data in later modules.
Module 3 describes the chemistry, manufacturing, and control (CMC) information for both drug substance and drug product. It includes specifications, analytical methods, batch records, validation data, and stability studies. This is the foundation for demonstrating that the product can be consistently manufactured to the required standards.
This module contains all pharmacology, pharmacokinetic, and toxicology studies conducted in animals or in vitro. The data supports the safety profile of the product before clinical testing and eventual approval.
The final module compiles clinical trial data, including Phase I–III studies, statistical analyses, and integrated summaries of efficacy and safety. It demonstrates that the product performs as intended in human subjects.
The challenge for most sponsors lies in maintaining alignment between these modules as studies evolve, manufacturing data updates, and documents are revised. Even a small version mismatch can raise validation questions during the EMA review process.
Teams that manage these modules in separate systems often struggle to keep data consistent across functions. A unified document management system prevents these disconnects by linking each study, report, and dataset back to the same verified source. This ensures that every module of the MAA tells a complete and traceable story from development through commercial readiness.
Submitting a Marketing Authorisation Application is a complex process that tests how well an organization can align science, documentation, and regulatory compliance. Even for experienced teams, the path from final study to submission is filled with potential pitfalls that can delay approval or trigger costly rework.
In many organizations, regulatory, quality, and clinical teams operate in separate systems. Data and documents often need to be copied or reconciled manually, which introduces version control issues and the risk of inconsistencies across CTD modules. When reviewers identify discrepancies, the validation clock pauses while the sponsor corrects and resubmits.
Clinical data, manufacturing specifications, and nonclinical findings must align perfectly. If updates to one area are not reflected in the others, regulators may question data integrity. Even small discrepancies, such as mismatched lot numbers or assay references, can trigger significant review delays.
The EMA frequently issues requests for clarification or additional data during the validation phase. If sponsors lack a structured system for tracking document dependencies, addressing these questions becomes a time-consuming process that can push back approval timelines.
Every modification to a controlled document can trigger revalidation requirements. Teams using disconnected tools struggle to demonstrate proper version histories, approvals, and electronic signatures that meet 21 CFR Part 11 and Annex 11 standards.
For smaller biotechs, the same experts responsible for data generation are often responsible for document compilation and review. Without a centralized system, administrative tasks multiply, pulling resources away from higher-value work like strategy and agency engagement.
Each of these challenges stems from one underlying issue: disconnected information. When the systems housing regulatory, clinical, and quality data do not speak to each other, submission teams spend valuable time chasing alignment instead of advancing review.
Organizations that unify their data and document management early in development are better equipped to meet submission timelines and reduce validation risk. With a single source of truth, sponsors can maintain control over their MAA from draft to approval without losing visibility or compliance assurance.
Preparing a Marketing Authorisation Application is an enormous undertaking, but the process can be managed more efficiently with the right structure, systems, and collaboration. Sponsors that approach submission readiness as an ongoing discipline rather than a final push are more likely to meet timelines, reduce validation cycles, and maintain full compliance.
Successful submissions begin long before dossier assembly. Organizing development documents in the Common Technical Document (CTD) format from the start helps teams maintain consistency as studies progress. Using templates for modules, summaries, and reports makes it easier to adapt materials for different markets without reworking core content.
When regulatory, quality, and clinical functions use separate tools, data inconsistencies are almost inevitable. A unified electronic document management system (eDMS) allows every contributor to work from the same file repository, ensuring that updates in one area are instantly reflected across all modules. This prevents version confusion and eliminates the need for document reconciliation at submission time.
Every document included in an MAA must meet GxP requirements for traceability and approval. Using a validated platform ensures that audit trails, electronic signatures, and version histories are compliant with both 21 CFR Part 11 and EU Annex 11. It also simplifies the process of demonstrating to regulators that the system itself has been qualified for use.
Real-time visibility across teams reduces the risk of late-stage surprises. Sponsors who track dependencies between modules can respond faster to agency questions or variations, avoiding unnecessary resubmissions. Built-in workflows also standardize review and approval processes, helping teams stay inspection-ready throughout the product lifecycle.
Kivo’s unified DMS was designed for this exact challenge. It connects regulatory, quality, and clinical teams in one validated environment, eliminating document silos and reducing revalidation work. Sponsors can assemble their CTD directly within Kivo using controlled templates, link data across all five modules, and maintain a clear audit trail from draft through submission.
For sponsors preparing an MAA, Kivo transforms the submission process from a manual, error-prone effort into a coordinated, auditable, and efficient operation that supports both regulatory success and long-term scalability.
Receiving a Marketing Authorisation is not the end of regulatory oversight. Once a product is approved, sponsors must maintain ongoing compliance through post-authorization activities that ensure continued safety, quality, and efficacy. These requirements are essential for protecting patients and sustaining the product’s presence in the market.
After approval, sponsors are responsible for monitoring, collecting, and reporting adverse events. They must maintain a pharmacovigilance system that complies with Good Pharmacovigilance Practice (GVP) and submit Periodic Safety Update Reports (PSURs) at defined intervals. These reports give regulators an updated view of the product’s benefit–risk balance and highlight any new safety concerns.
Changes to the manufacturing process, specifications, or labeling require formal variation submissions. Sponsors must document these updates with the same rigor as the original MAA. Type IA and IB variations can often be implemented quickly, but Type II variations (those with potential impact on quality, safety, or efficacy) require prior approval. Periodic renewals, typically every five years, also demand complete traceability of data and processes since the last authorization.
In some cases, the EMA may request additional clinical or nonclinical studies to further evaluate long-term safety or performance. These Post-Authorisation Safety Studies (PASS) and Post-Authorisation Efficacy Studies (PAES) must be tracked, reported, and documented within the same quality framework that governed the MAA.
Sponsors are required to retain documentation related to the MAA and subsequent changes for the product’s entire lifecycle. Auditors and inspectors may request access to records at any time. Maintaining these materials in a validated system with complete audit trails simplifies inspection preparation and reduces the risk of findings related to data integrity.
A unified document management system is the foundation for meeting these ongoing obligations. By managing pre- and post-authorization records in the same validated environment, sponsors can ensure continuity between initial approval and future lifecycle activities.
Kivo’s integrated platform supports this full lifecycle approach. Once an MAA is approved, sponsors can continue managing variations, renewals, and safety documentation without revalidating or duplicating files across systems. This continuity reduces compliance risk and allows teams to focus on what matters most: maintaining safe, effective therapies for patients.
The Marketing Authorisation Application is the defining milestone in bringing a therapy to market in the European Union. It represents years of work across research, manufacturing, and regulatory functions, all converging into one complete submission that must withstand the highest level of scrutiny.
Achieving approval requires more than regulatory expertise. It depends on data integrity, version control, and cross-functional collaboration. Every part of the Common Technical Document must tell a consistent story, from manufacturing to clinical results. When sponsors manage these pieces in disconnected systems, they risk inconsistencies that delay review and raise compliance concerns.
Centralizing documentation within a validated environment changes that dynamic. Teams gain visibility across the full submission lifecycle, from early data generation to post-authorization updates. Regulatory questions can be answered quickly, audit trails are automatically maintained, and duplicate validation work is eliminated.
Kivo enables this unified approach. By combining regulatory, quality, and clinical document management in one compliant system, sponsors can prepare, submit, and maintain their MAAs with confidence. It’s how emerging biotechs scale operations, how mid-sized pharma teams stay inspection-ready, and how global sponsors bring therapies to patients faster without compromising compliance.
Schedule a demo to see how Kivo simplifies the MAA process and helps your team move from development to approval with speed, clarity, and control.