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

Monitoring Plan

Describes the monitoring methods, responsibilities, and requirements for the trial. It includes a brief description of the study, its objectives, and the critical data and study procedures.

The plan describes the reference policies and procedures to follow.

Project Management Plan

The purpose of this document is to define the scope of activities, outline responsibilities (define task and roles) and provide guidance on a specific project.

EUDAMED

Is the European Databank on Medical Devices. It’s a secure, web-based portal that acts as a central hive for the exchange of information between national competent authorities and the European Commission.

ISO14155

International standard addressing good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.

Redaction

In relation to Policy 70, the process of permanently obscuring CCI or PPD in the clinical documentation submitted to EMA by the applicant/MAH before the documents are published. Tthe redaction should appear as a light blue box with a black 'PPD' label or as a black box with a red 'CCI' label.

Informed Consent Form (ICF)

Patients, and/or in specific circumstances their legally designated representative(s), are requested to give written consent before participating in a clinical trial.

Anonymization Report (AR)

Part of the Policy 70 submission package. It should describe the methodology of the anonymisation applied in the submitted clinical reports, and how the risk of re-identification has been addressed.

Anonymization

The process of rendering data into a form which does not identify individuals and where identification is not likely to take place, for example to comply with the requirements of Policy 70. 

In Silico

Named after the silica, main component of computer parts. In silico technologies encompass a large number of approaches that may assist in the prediction of toxicity and fate of new and existing chemicals.

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