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

Paediatric Investigation Plan (PIP)

A paediatric investigation plan (PIP) is a development plan aimed at ensuring that the necessary data are obtained through studies in children, to support the authorisation of a medicine for children in Europe.

Substantial Amendment (SA)

A substantial amendment (SA) is a change to the conduct of the clinical trial that has a significant impact on the safety of the subjects or the scientific value of the study.

Standard of Care

Care delivered by a healthcare provider for a specific patient which should correspond to the care that an averagely competent physician in the same field would provide under similar circumstances.

Scientific Advice

Advice given by a regulatory/ reimbursement authority to a manufacturer on appropriate tests and studies to be performed during product development/ application for product reimbursement, in order to avoid major objections being raised during evaluation of the marketing authorisation application/

Non-substantial Amendment

A non-substantial amendment is a change to the conduct of the clinical trial that does not have a significant impact on the safety of the subjects or the scientific value of the study.

Real World Study (RWS)

Studies investigating health interventions whose design does not follow the design of a highly-controlled RCT and aims to reflect health intervention effectiveness in routine clinical practice.

Market/patient Access

Market access is the definition and achievement of a strategy aiming that all patients included in a target population will receive a fast, secured and long-term access to a health tech product in development and at the right price, both for the manufacturer and the payer considering th

Environment Scanning

Identification of the stakeholders which are likely to use, benefit or assess the health tech product in development and which opinions, publications and priorities should be identified and considered.

Patient Centricity for Biotechs

Priority given to offering an optimal quality of life to patients along all the steps to real access of a health tech product in development with a continuous dialogue with stakeholders in which patient expertise matters, while accurate and intelligible information is delivered to patients and fa