Marketing Authorisation Application (MAA)
We can take you through the marketing authorisation application process - from early phase scientific advice and regulatory strategy to compiling the common technical document for MAA submission.
The Marketing Authorisation Application (MAA) is the sum of years of development. We have worked as part of the global filing team for parallel submissions to the FDA, EMA, and other national health authorities.
Optimise Your Project Plan
We provide project planning and management of your submission, from phase 1 through to compiling your MAA dossier.
Crystalise Key Messaging
We can help with key messaging, company core data sheet preparation, and regional labelling.
Address Issues Effectively
We attend regulatory meetings with authorities to help you address Day-120 questions and Day-180 outstanding issues.
Download our free guide
This guide explains—at a high level—the different considerations in the planning and submission of the MAA and new drug/biologics licence application.
What are the key MAA pre-submission steps?
MAA pre-submission steps include determining the legal basis for the MAA and confirming eligibility for evaluation under the centralised procedure. Understanding the data requirements specific to each legal basis is critical to building the dossier.
A key step is submitting an eligibility request and letter of intent, which are essential for access to the centralised procedure, and assigning rapporteurs for evaluation.
Product naming is another important consideration, as any product name for a centralised procedure must be approved by the Naming Review Group (NRG).
Building your MAA dossier is also a critical part of the overall MAA process.
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How Somerville Development Partners can help you
We have taken many clients through the marketing authorisation application process, from early phase scientific advice and regulatory strategy, to compiling the common technical document for MAA submission. We have attended many regulatory meetings with authorities to help clients address the Day 120 list of questions and Day 180 list of outstanding issues, all the way to approval.
What is the Common Technical Document?
The common technical document (CTD) is the structured format for submitting new medicine applications to regulatory authorities, including the European Medicines Agency (EMA) and the Food and Drug Administration (FDA). It is comprised of five modules which correspond to different aspects of a medicinal product's development, including quality, non-clinical and clinical aspects.
What are the five modules of the CTD?
Module two of the CTD includes overview and summary documentation related to quality, non-clinical and clinical development of a medicinal product. Modules three to five include the detailed quality, non-clinical and clinical documents and evidence about a medicine's development, respectively.
Module 1 is not part of the formal CTD and contains region-specific information. It is the module that comprises a substantial number of documents, with administrative and product-specific information. It’s worth noting that Module 1 is part of an initial MAA under the centralised procedure. In the European Union (EU), the Module 1 key components are (the list is not exhaustive).
Understanding the key regulatory deliverables in the lead up to submitting an MAA and compiling the most comprehensive marketing authorisation application is imperative to pass validation and reduce the number of questions and potential objections from regulatory authorities during MAA evaluation.
What are the procedures for marketing authorization (MA)?
There are three types of marketing authorization procedures in the EU:
- Centralised Procedure.
- Decentralised Procedure.
- Mutual Recognition Procedure.
What is the difference between a full MA and a conditional marketing authorization (CMA)?
A full MA is granted—based on complete safety and efficacy data—in the assigned indication for a medicine. A CMA is granted when a regulatory authority considers the benefit of the medicinal product being immediately available to patients outweighs the risks from the sponsor not yet having collected the most comprehensive safety and efficacy data.
What is a conditional marketing authorization?
A CMA is granted under specific circumstances, for instance, due to a great public health need or for orphan and life-threatening diseases. This means that often, CMAs are granted at a stage in development when you may not have the most comprehensive safety and efficacy data available. Therefore, approval is granted with stipulations that you complete ongoing studies and conduct/potentially conduct new studies to collect comprehensive data.
Who can be a marketing authorisation holder (MAH)?
In Europe, an MAH is an individual or company that is legally allowed to commercialise, market and distribute a medicine after being granted an MA by the competent authority or the EMA.
What is the difference between an NDA, BLA and an MAA?
An MAA is an application for medicine approval in Europe. An NDA is an application for medicine approval in the USA. A BLA is an application for biologics approval in the USA.
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We have supported 40+ marketing applications