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

The measurement of a medicine's desired effect as compared to another healthcare intervention under ideal conditions, such as in a clinical trial.

Effectiveness

The achievement of desired results under the usual circumstances of health care practice.

Environmental Risk Assessment (ERA)

In accordance with Article 8(3) of Directive 2001/83/EC, as amended, the evaluation of the potential environmental risks posed by medicinal products should be submitted, their environmental impact should be assessed and, on a case-by-case basis, specific arrangements to limit the impact should be

Committee for Advanced Therapy (CAT)

The Committee for Advanced Therapies (CAT) is the European Medicines Agency's (EMA) committee responsible for assessing the quality, safety and efficacy of advanced therapy medicinal products (ATMPs) and following scientific developments in the field.

Somatic-Cell Therapy medicinal Products (sCTP)

These contain cells or tissues that have been manipulated to change their biological characteristics or cells or tissues not intended to be used for the same essential functions in the body. They can be used to cure, diagnose or prevent diseases.

Tissue Engineered Product (TEP)

A human tissue-engineered product (hTEP) means any autologous or allogeneic product which:

 • contains, consists of, or results in engineered human cells or tissues; and

Value Proposition

The value proposition is composed of a common understanding of patient flow to identify where value is being lost, where new value can be created and how the company can best capture that value.

Health Economics and Outcomes Research (HEOR)

Health Economics and Outcomes Research (HEOR) is the most common label given to the function within pharmaceutical and life science companies with the responsibility for generating evidence of value of new interventions for reimbursement agencies

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