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

Conditional Marketing Autorisation

The approval of a medicine that address unmet medical needs of patients on the basis of less comprehensive data than normally required.

Compassionate Use

The use of an unauthorised medicine outside a clinical study in individual patients under strictly controlled conditions. This helps to make medicines that are still under development available to patients.

Notified Body

An accredited body that conducts conformity assessments for medical devices.

Affordability

Affordability is the capability to allocate financial funds to an individual or societal need.

Real World Evidence (RWE)

Real World Evidence (RWE) is the evidence derived from the analysis and/or synthesis of real-world data (RWD).

Real World Data (RWD)

An umbrella term for data regarding the effects of health interventions (e.g. safety, effectiveness, resource use, etc) that are not collected in the context of highly-controlled RCT's.

Patient Reported Outcome (PRO)

A measurement based on a report that comes directly from the patient (i.e., study subject) about the status of a patient’s health condition without amendment or interpretation of the patient’s response by a clinician or anyone else.

Patent

An official document securing the exclusive right to make, use, or sell an invention to its inventor for a defined period.

Indication

A medical condition that a medicine is used for. This can include the treatment, prevention and diagnosis of a disease.

Health Technology Assessment

HTA is a multidisciplinary process that summarises information about the medical, social, economic, and ethical issues related to the use of health technology in a systematic, transparent, unbiased, robust manner.

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