Marketing Authorisation Application (MAA) Submission Guide

Last Updated: November 2026

What is an MAA submission, and how does the Marketing Authorisation Application process work in the EU?

An MAA submission is the formal application a sponsor files to sell a medicine in the European Union. It is an eCTD dossier covering quality, nonclinical, and clinical data, submitted through one of four procedures: centralised (via the EMA), decentralised, mutual recognition, or national. In the centralised procedure, the EMA's CHMP has up to 210 active days to give its opinion, and the European Commission then issues the authorisation.

Table of Contents

• What Is a Marketing Authorisation Application (MAA)?
• When an MAA Is Required
• MAA Submission Procedures in the EU
• The MAA Submission Process, Step by Step
• Structure of the MAA Dossier
• What the EU Pharma Package Changes for MAAs
• Common Challenges in MAA Submissions
• How Sponsors Can Streamline the MAA Process
• Post-Authorisation Responsibilities
• How Regulatory Platforms Compare for MAA Preparation
• FAQ

What Is a Marketing Authorisation Application (MAA)?

A Marketing Authorisation Application (MAA) is the formal request to place a medicinal product on the market in the European Union. It is reviewed either by the European Medicines Agency (EMA) or by national competent authorities, depending on the procedure, and it must show that the product is consistently manufactured, clinically effective, and safe for patients.

The MAA is the EU counterpart of the U.S. New Drug Application (NDA) and Biologics License Application (BLA), but it runs under the EU's shared regulatory model. Sponsors submit data from nonclinical and clinical studies along with detailed descriptions of their manufacturing processes, facilities, and quality management systems.

An approved MAA results in a Marketing Authorisation. Depending on the submission pathway, it covers every EU and EEA member state (centralised procedure) or a specific set of countries (decentralised, mutual recognition, or national procedures). In 2025, the EMA recommended 104 human medicines for marketing authorisation, 38 of which contained a new active substance, according to the agency's 2025 annual report (as reported by PharmTech).

For sponsors, the MAA is both a scientific and a logistical challenge. Every document must be traceable, every dataset consistent, and every version controlled, because the submission becomes the definitive regulatory record of the product.

When an MAA Is Required

An MAA is required whenever a sponsor wants to place a medicinal product on the market in the European Union or European Economic Area. That includes innovative therapies, biosimilars, and generics. MAAs apply across a range of product types:

• New active substances that have never been approved in the EU.
• Generics that reference a previously authorised 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. Every route uses the same core dossier, built in the Common Technical Document (CTD) format.

MAA Submission Procedures in the EU

There are four MAA procedures in the EU: centralised, decentralised (DCP), mutual recognition (MRP), and national. The centralised procedure gives one authorisation valid across the whole EU and EEA and is mandatory for certain product types. The other three are run by national authorities and cover only the member states the sponsor chooses.

The Centralised Procedure in Detail

The centralised procedure provides a single, EU-wide marketing authorisation through one submission and one evaluation. It is coordinated by the EMA and ends in one European Commission decision that is valid across the region.

The procedure is mandatory for:

• Biotechnology-derived medicines produced by recombinant DNA technology, cell hybridisation, or other biotechnological processes.
• Advanced therapy medicinal products (ATMPs), including gene, cell, and tissue-engineered therapies.
• Orphan medicines intended for rare diseases.
• Products containing a new active substance for cancer, diabetes, neurodegenerative disorders, HIV/AIDS, viral diseases, or autoimmune and other immune dysfunctions.

It is optional for other innovative products that represent a significant therapeutic, scientific, or technical innovation, or whose authorisation would be in the interest of public health across the EU.

The Committee for Medicinal Products for Human Use (CHMP) performs the scientific evaluation, with the Pharmacovigilance Risk Assessment Committee (PRAC) assessing the risk management plan and, for ATMPs, input from the Committee for Advanced Therapies (CAT). If the CHMP adopts a positive opinion, the European Commission grants the final authorisation. For a deeper look at managing multi-region filings, see how a RIM system supports global submissions planning.

The MAA Submission Process, Step by Step

For a centralised MAA, the process starts up to 18 months before the dossier is filed and ends with a European Commission decision. These are the main steps and timings set out in the EMA's step-by-step guidance:

1. Eligibility request (18 to 7 months before submission). The sponsor confirms that the product can use the centralised procedure.
2. Notification of intended submission (7 months before). The sponsor tells the EMA when it plans to file.
3. Pre-submission meeting (6 to 7 months before, recommended). The sponsor discusses procedural and regulatory questions with the EMA.
4. Rapporteur appointment. The CHMP and PRAC appoint the (co-)rapporteurs who will lead the scientific assessment.
5. Re-confirmation of the submission date (2 to 3 months before).
6. Submission and validation. The dossier is filed in eCTD format through the eSubmission Gateway or Web Client, and the EMA checks that all essential regulatory elements are present before the assessment starts.
7. Scientific assessment (up to 210 active days). The CHMP evaluates the application. The clock stops whenever the sponsor is answering the committee's questions, so the total elapsed time is longer than 210 calendar days.
8. European Commission decision. After a positive CHMP opinion, the Commission issues the legally binding marketing authorisation.

Products of major interest for public health and therapeutic innovation can request accelerated assessment, which cuts the CHMP timeframe to 150 days. The EMA asks for that request at least two to three months before the MAA is submitted.

Structure of the MAA Dossier

Every MAA follows the Common Technical Document (CTD), the harmonised structure from the International Council for Harmonisation (ICH), and is submitted electronically as an eCTD. The CTD has five modules:

• Module 1: Administrative and product information. Region-specific forms and proposed product information. In the EU, this includes the summary of product characteristics (SmPC), package leaflet, and labelling mock-ups.
• Module 2: Summaries and overviews. High-level summaries of the quality, nonclinical, and clinical data.
• Module 3: Quality (CMC). Chemistry, manufacturing, and controls for the drug substance and drug product, including specifications, analytical methods, batch and validation data, and stability studies.
• Module 4: Nonclinical study reports. Pharmacology, pharmacokinetic, and toxicology studies.
• Module 5: Clinical study reports. Phase I to III trial data, statistical analyses, and integrated summaries of efficacy and safety.

eCTD v3.2.2 and eCTD v4.0

eCTD is mandatory for all marketing authorisation submissions in all EU procedures, and eCTD v3.2.2 remains the standard format. For new centralised MAAs, the EMA has accepted eCTD v4.0 on an optional basis since 22 December 2025, plans to make it strongly recommended from Q1 2027, and plans to make it mandatory from Q1 2028. Sponsors must contact the EMA's eCTD v4.0 team before filing in v4.0. For background, see everything you need to know about eCTD 4.0 and what eCTD publishing and validation tools should include.

The hardest part for most sponsors is keeping these modules aligned as studies evolve, manufacturing data changes, and documents are revised. Even a small version mismatch can raise questions during validation or assessment.

What the EU Pharma Package Changes for MAAs

The EU pharma package is a new Directive and Regulation that will replace Directive 2001/83/EC and Regulation (EC) No 726/2004. It changes the timelines and incentives that apply to MAAs, but not for applications already in progress. The EU institutions reached political agreement in December 2025 and the Council adopted its position in September 2026. As of mid-October 2026, the European Parliament's final vote and publication in the Official Journal were still pending, and most provisions are expected to apply around late 2028.

The changes most relevant to MAA sponsors, based on the agreed texts:

• The standard EMA scientific assessment shortens from 210 to 180 days.
• Regulatory data protection stays at eight years, while baseline market protection shortens. Additional protection can be earned through conditions such as addressing unmet medical need or running comparative trials.
• An environmental risk assessment becomes mandatory for every MAA, including generics and biosimilars.
• Applications submitted before the new rules apply will continue to be governed by the current rules.

Until the final texts are published, sponsors planning a filing for 2028 or later should confirm which rules will apply to their application.

Common Challenges in MAA Submissions

Most MAA delays come from disconnected information rather than missing science. The most common problems are:

• Fragmented documentation. Regulatory, quality, and clinical teams work in separate systems, so documents are copied or reconciled by hand, which introduces version-control issues across CTD modules.
• Inconsistent data across modules. If an update to clinical data, manufacturing specifications, or nonclinical findings isn't reflected everywhere, assessors question data integrity. Even mismatched lot numbers or assay references can cause delays.
• Late-stage changes and agency questions. Without a structured way to track document dependencies, answering CHMP questions during a clock stop takes longer than it should.
• Weak audit trails. Teams using disconnected tools struggle to show version histories, approvals, and electronic signatures that meet 21 CFR Part 11 and EU Annex 11 expectations.
• Resource bottlenecks. At clinical-stage biotechs, the experts who generate the data often also compile and review the documents, so administrative work pulls them away from strategy and agency engagement.

How Sponsors Can Streamline the MAA Process

Sponsors that treat submission readiness as an ongoing discipline, rather than a final push, are more likely to meet timelines and reduce questions during assessment. Four practices make the biggest difference:

1. Start early with CTD-aligned templates. Organising development documents in CTD structure from the start keeps content consistent as studies progress and makes it easier to adapt materials for other markets.
2. Centralise quality, clinical, and regulatory files. A single validated document management system means an update in one area is reflected across every module, so there is nothing to reconcile at submission time.
3. Keep validation-ready controls in place. Audit trails, electronic signatures, and version histories that meet Part 11 and Annex 11 make it simple to show assessors and inspectors that the record is trustworthy.
4. Track agency correspondence and commitments. Linking every question, response, and commitment to the documents and submissions it affects speeds up answers during clock stops and keeps post-approval obligations visible. See what a connected regulatory submission system needs.

Post-Authorisation Responsibilities

A Marketing Authorisation starts a new set of obligations. Once the product is approved, sponsors have to keep showing that it remains safe, effective, and well made:

• Pharmacovigilance and safety reporting. Sponsors run a pharmacovigilance system that complies with Good Pharmacovigilance Practices (GVP) and submit Periodic Safety Update Reports (PSURs) at defined intervals.
• Variations. Changes to manufacturing, specifications, or labelling require formal variation submissions. Type IA and IB variations can often be implemented quickly, while Type II variations, which can affect quality, safety, or efficacy, need prior approval.
• Renewal. Under the current rules, an EU marketing authorisation is valid for five years and then needs one renewal. After that, it is generally valid indefinitely unless the authority requires another five-year renewal for pharmacovigilance reasons.
• Post-authorisation studies. Regulators may require Post-Authorisation Safety Studies (PASS) or Post-Authorisation Efficacy Studies (PAES), which must be tracked and reported within the same quality framework as the MAA.
• Record retention and inspection readiness. Documentation for the MAA and every later change must be kept for the product's lifecycle and produced on request.

Managing pre- and post-authorisation records in the same validated environment keeps the line from initial approval to later lifecycle activity unbroken. For teams handling several indications, see what a RIM system needs to manage multiple indications.

How Regulatory Platforms Compare for MAA Preparation

Many sponsors move MAA preparation onto a dedicated regulatory platform once spreadsheets and shared drives stop scaling. The options below are a starting point, not an independent ranking. This table does not assess implementation quality, market share, or fit for any particular organisation, so validate every option against your own requirements.

For more options, see three Veeva RIM alternatives for growing regulatory teams.

How Kivo Helps

Kivo connects regulatory, quality, and clinical teams in one validated environment, so the documents behind every CTD module come from the same controlled source. Teams build their MAA in pre-built submission structures aligned to agency guidelines, with each document linked back to the DMS. When the content is ready, Kivo prepares a submission-ready package with automatic change tracking for handoff to the team's chosen internal or external eCTD publisher. Submitted eCTDs stay viewable in Kivo, linked to their source documents.

After the MAA goes in, Kivo's correspondence and commitment tracking keeps CHMP questions, responses, and post-authorisation commitments tied to the right documents and submissions. Variations, renewals, and safety documentation then continue in the same system. Kivo RIM is rated 4.9/5 on G2, and more than 200 sponsor, consultant, and CRO teams run their regulatory, clinical, and quality work on Kivo. Explore Kivo RIM.

Frequently Asked Questions

What is an MAA submission?

An MAA submission is the application a sponsor files to market a medicine in the European Union. It is an eCTD dossier, structured in the five CTD modules, that presents the product's quality, nonclinical, and clinical data. It is reviewed by the EMA in the centralised procedure, or by national authorities in the decentralised, mutual recognition, and national procedures.

How long does the EMA take to review an MAA?

In the centralised procedure, the CHMP has up to 210 active days to adopt its opinion, not counting clock stops while the sponsor answers questions. The European Commission then issues the decision. Accelerated assessment cuts the CHMP timeframe to 150 days for products of major public health interest.

What is the difference between the centralised and decentralised procedures?

The centralised procedure gives one EU-wide authorisation after a single EMA assessment, and it is mandatory for products such as biotech medicines, ATMPs, and orphan drugs. The decentralised procedure is run by national authorities: one Reference Member State assesses the dossier and the other selected countries adopt its conclusion.

Is eCTD v4.0 required for an MAA?

Not yet. eCTD v3.2.2 remains accepted. For new centralised MAAs, the EMA has allowed eCTD v4.0 on an optional basis since December 2025, plans to make it strongly recommended from Q1 2027, and plans to make it mandatory from Q1 2028.

What is the difference between an MAA and an NDA?

Both ask a regulator for permission to market a medicine and both use the CTD structure. An NDA (or BLA, for biologics) is filed with the U.S. FDA. An MAA is filed in the EU, either centrally with the EMA or through national procedures, and its Module 1 follows EU-specific requirements such as the SmPC and package leaflet.

Summary

The Marketing Authorisation Application is the milestone that brings a therapy to patients in the European Union. Choosing the right procedure early, planning the centralised pre-submission steps up to 18 months ahead, and keeping every CTD module consistent are what keep an MAA on schedule. With eCTD v4.0 and the EU pharma package both arriving over the next few years, sponsors that manage regulatory, quality, and clinical content in one validated system will find those transitions easier.

Schedule a demo to see how Kivo helps your team move from development to approval with clarity and control.