An MAA (Marketing Authorisation Application) and a BLA (Biologics License Application) are two distinct regulatory submission pathways that differ primarily by geography and governing authority. An MAA is submitted to the European Medicines Agency or a national competent authority within the EU, while a BLA is submitted to the U.S. Food and Drug Administration. The key distinction is not just procedural – each pathway follows its own legal framework, dossier format, and review timeline. The sections below break down the most important differences companies need to understand before planning their regulatory submissions.
Which regulatory authority reviews an MAA versus a BLA?
An MAA is reviewed by the European Medicines Agency (EMA) through the centralized procedure, or by national competent authorities in EU member states through decentralized or mutual recognition procedures. A BLA is reviewed exclusively by the U.S. Food and Drug Administration (FDA), specifically by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER), depending on the product type.
The centralized procedure at the EMA results in a single marketing authorization valid across all EU member states, which makes it the preferred route for most biologics and advanced therapies. In contrast, a BLA approval grants authorization to market a product in the United States only. Companies seeking access to both markets must engage with both authorities independently, as there is no formal joint review mechanism between the EMA and FDA, although parallel scientific advice is available to help align development programs early. Learn more about how we support these processes on our services page.
What types of products require a BLA instead of an MAA?
A BLA is required in the United States for biological products, including monoclonal antibodies, recombinant proteins, vaccines, blood and blood components, gene therapies, and cellular therapies. Small molecule drugs, by contrast, are typically approved via a New Drug Application (NDA) in the U.S. In Europe, the MAA covers both small molecules and biologics under the same application framework, meaning there is no separate “BLA equivalent” in EU terminology.
This is an important distinction for companies developing biologic products. In the EU, a biologic medicine follows the MAA pathway regardless of whether it is a monoclonal antibody, a vaccine, or a recombinant protein. The EMA’s Committee for Medicinal Products for Human Use (CHMP) assesses all of these under a unified process. In the U.S., the BLA pathway is specifically reserved for biological products as defined under the Public Health Service Act, and the regulatory requirements reflect the additional complexity of manufacturing and characterizing these products.
How does the MAA review process differ from the BLA review process?
The MAA centralized procedure at the EMA follows a 210-day active review timeline, with clock stops that allow applicants to respond to questions from the CHMP. The BLA review at the FDA operates on a standard 12-month review clock from the date of acceptance, or a 6-month priority review for products that address serious conditions with unmet medical need. Both processes include formal rounds of questions, but the structure and terminology differ significantly.
The EMA process involves a rapporteur and co-rapporteur system, where two member state experts lead the scientific assessment on behalf of the CHMP. The FDA process is managed internally by review divisions within CDER or CBER, with a single primary reviewer and discipline-specific reviewers for chemistry, clinical pharmacology, and other areas. Both agencies conduct pre-submission meetings, but the FDA’s pre-BLA meeting is a more formalized milestone that many companies use to align on submission readiness before filing.
What dossier format is required for each submission?
Both the MAA and the BLA use the Common Technical Document (CTD) format, which is the internationally harmonized structure developed through the International Council for Harmonisation (ICH). The CTD is organized into five modules covering administrative information, summaries, quality, nonclinical, and clinical data. Despite sharing the same framework, the specific content requirements and regional administrative modules differ between the two submissions.
Module 1 regional requirements for an MAA
For an MAA, Module 1 contains EU-specific administrative and prescribing information, including the product information documents (Summary of Product Characteristics, labeling, and package leaflet), application forms, and proof of payment. The EMA has detailed guidance on what must be included, and compliance with the EU format is strictly enforced during the validation step before formal review begins.
Module 1 regional requirements for a BLA
For a BLA, Module 1 contains FDA-specific content, including the U.S. prescribing information (package insert), FDA application forms, and patent and exclusivity certifications. The FDA also requires electronic submissions through its Electronic Submissions Gateway, and the BLA must be compiled in accordance with FDA’s eCTD technical specifications. Errors in the electronic submission format are a common reason for refuse-to-file decisions.
Can a company submit an MAA and a BLA at the same time?
Yes, a company can submit an MAA and a BLA simultaneously. Running parallel submissions to the EMA and FDA is a common strategy for companies seeking global market access, particularly for biologics with significant commercial potential. There is no regulatory rule preventing concurrent filings, and many sponsors choose to submit within weeks of each other to minimize the time gap between EU and U.S. approvals.
Successful parallel submissions require careful planning because the two dossiers, while sharing the same CTD core data, must be tailored to meet the specific requirements of each authority. Clinical data packages, labeling conventions, and risk management documentation all differ between the EU and U.S. contexts. Companies pursuing this strategy often use the EMA-FDA parallel scientific advice program earlier in development to identify potential divergences and address them before submission, reducing the risk of major objections from either agency. Our experienced team has guided numerous clients through exactly this kind of complex, dual-track submission process.
What are the most common reasons MAA or BLA submissions fail?
The most common reasons regulatory submissions fail include insufficient clinical evidence to demonstrate efficacy or safety, unresolved chemistry, manufacturing, and controls (CMC) issues, and incomplete or inconsistent data packages. Procedural failures such as dossier formatting errors, missing administrative documents, or non-compliance with electronic submission requirements can also result in a refusal to validate or a refuse-to-file decision before the scientific review even begins.
Beyond technical deficiencies, strategic missteps contribute significantly to submission failures. These include:
- Inadequate pre-submission engagement with the regulatory authority, leading to misaligned expectations on the evidence required
- Poorly defined regulatory strategy that fails to anticipate questions on benefit-risk balance
- CMC data gaps, particularly around comparability studies for biologics or process validation for complex manufacturing
- Inconsistencies across modules, where clinical summaries contradict data presented in the study reports
- Labeling disagreements that delay approval even after the scientific review is complete
For biologics specifically, manufacturing complexity means that CMC-related objections are disproportionately common in both MAA and BLA reviews. Regulators expect thorough characterization of the product, robust analytical methods, and clear demonstration that the manufacturing process consistently produces a product of defined quality. Addressing these areas proactively – ideally through pre-submission meetings and scientific advice – significantly improves the likelihood of a successful outcome.
How Starodub supports MAA and BLA submissions
Navigating parallel regulatory submissions across the EU and U.S. requires more than familiarity with the CTD format. It demands a deep understanding of each authority’s expectations, the ability to anticipate scientific objections, and the experience to build a dossier that holds up under scrutiny. At Starodub, we support biopharmaceutical companies at every stage of the regulatory submissions process, from early strategy through to approval.
Our team works with clients on both MAA and BLA submissions, offering:
- Regulatory strategy development and pathway selection for biologics, small molecules, and advanced therapies
- CMC regulatory support, including dossier preparation, gap analysis, and responses to regulatory questions
- Coordination of pre-submission meetings and scientific advice with the EMA and FDA
- Full CTD dossier compilation, review, and quality checking for both EU and U.S. submissions
- Lifecycle management support following initial approval
With over 400 completed projects and more than 300 clients supported, we bring practical, hands-on experience to every submission. If you are planning an MAA, a BLA, or a parallel submission strategy, contact us today to discuss how we can help you build a strong, complete dossier and move efficiently toward market approval.
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