Possibly the highest level of medicine-like health claim that can be made on a non-drug product. It describes the propensity for the product or dietary ingredient to aid in the reduction of the risk factors associated with particular diseases.
Marketing Authorization Application (MAA)
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
The European network for Health Technology Assessment is a network of government-appointed organizations from European Union Member States, the European Economic Area and accession countries as well as a large number of relevant regional agencies and non-for-profit organizations that produce or c
A harmonized application form is used for clinical trial applications across the European Union.
The submission of data on medicines by marketing-authorisation holders into the EVMPD is a legal requirement from the 2010 pharmacovigilance legislation.
Electronic or paper filing system which must contains all study documents and at least essential documents as described in ICH E6.
Clinical trial sponsors are required to notify regulatory authorities and ethics committees when their clinical trials have ended.
As defined in ICH E6 “A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are accurate, and that the rights, integrity, and confidentiality of trial subjects ar
A logical mathematical framework demonstrating the quantitative relationship between a defined set of variables (e.g. cost, effectiveness, net benefit) based upon an explicit set of parameters and assumptions.
Comprehensive integrated analysis of the effectiveness of a study drug, recommended to be submitted to fulfil FDA requirements for an NDA or BLA in the US.
A medicine that contains an active substance or combination of active substances that has not been authorised before.