The marketing of medicinal products is conditioned by regulators’ approval, in order to ensure that therapeutic benefits outweigh risks.

Marketing Authorization Application

A Marketing Authorization Application provides comprehensive information about a drug, enabling regulatory agencies to assess Quality, Safety and Efficacy, and evaluate the ability of the future Marketing Authorization Holder (MAH) to ensure and monitor a sustainable benefit/risk ratio.

MAA in the European Union

Medicinal products may only be placed on the European Economic Area (EEA) marketplace once marketing has been authorized by regulatory authorities. Depending on the registration route – National Procedure, Decentralized Procedure, Mutual Recognition Procedure, or Centralized Procedure – Marketing Authorization Applications are submitted for assessment to national regulatory agencies, or to the Committee of Human Medicinal Products (CHMP) of the European Medicinal Agency (EMA). National marketing authorizations are granted by Member States, while ‘Union authorizations’ are issued by the European Commission (EC) for the entire Union.

The content of MAAs is dependent upon the applicable legal basis – legal bases are set out in Directive 2001/83/EC, and in Regulation (EC) No 726/2004. Consequently, dossiers can be full stand-alone or various types of abridged applications, for innovative, generic, hybrid, biosimilar, well-established, herbal or fixed combination medicinal products (non-exhaustive list).

MAA dossiers follow the structure and format of the Common Technical Document (CTD).

Latest Glossary Definitions

Efficacy-Effectiveness Gap

The observed discrepancy between effects of a health intervention in routine clinical practice as compared with the effects demonstrated in randomised controlled clinical trials.

Briefing Book (or briefing materials)

Documentation submitted to facilitate an Agency meeting, for example to request scientific advice in relation to a proposed drug development pathway. It should contain company questions, justifications or company positions, and appropriate summary information.

Clinical Impact

The effect that something is likely to have on the treatment of a particular group of people, or on the results of treating that group.

Commercially Confidential Information (CCI)

In relation to Policy 70, CCI shall mean any information contained in the clinical reports submitted to EMA by the applicant/MAH which is not in the public domain or publicly available and where disclosure may undermine the legitimate economic interest of the applicant/MAH.

Clinical Evaluation Report (CER)

Required under the new MEDDEV 2.7.1 Rev. 3 guidelines. Document containing information and results generated in conducting an evaluation of the clinical safety and performance of a medical device.

CE-Marking Technical File

A CE Technical File is a comprehensive collection of documents providing medical device composition, specifications, manufacturing process, rationale for qualification and classification, non-clinical testing results and clinical evaluations, risk analysis and instructions for use/Labeling.

Comparative Effectiveness Research (CER)

The conduct and/or synthesis of research comparing different benefits and harms of alternative interventions and strategies to prevent, diagnose, treat, and monitor health conditions in routine clinical practice (i.e. the real-world setting).

Core Value Dossier

Core value dossiers are used in the frame of reimbursement negotiations and to support HTA submissions, as well as national and local payers.

Core Reimbursement Dossier

A core reimbursement dossier is submitted during the late stage of development of a product, in order to be considered for reimbursement.

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