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Marketing Authorization Application (MAA)

Submitting your MAA or New Drug Application (NDA) / Biologics License Application (BLA) is a significant undertaking and we have supported many successful submissions.

How we can help with your MAA 

  • briefing books and slides for pre-submission interactions with the Food and Drug Administration (FDA), European Medicines Agency (EMA) and rapporteurs,
  • project planning and management of the submission,
  • key messaging, company core data sheet preparation, and regional labelling,
  • planning the data presentation, analysis, and discussion in the dossier,
  • a detailed review of the data shells to ensure the required analysis and outputs are planned,
  • writing Modules 1–5 of the common technical document,
  • publishing and submitting the completed submission,
  • responding to questions from the agency during the evaluation, and
  • providing peer-review of existing NDA / BLA and MAA projects.

We have worked as part of the global filing team for parallel submissions to the FDA, EMA, and other national health authorities.

marketing applications

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.

FAQs

What are the procedures for marketing authorization (MA)?

There are three types of marketing authorization procedures in the EU:

  1. Centralised Procedure.
  2. Decentralised Procedure.
  3. 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.

years of regulatory expertise

clients supported

agency interactions

orphan applications

marketing applications

We have supported 40+ marketing applications