Administering an investigational drug to humans is subject to prior approval from regulatory authorities.
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
Regulators’ review of a Clinical Trial Application (CTA) is, for a part, based on information about the investigational medicinal product(s) (IMP) provided by
The structure and format of applications to be submitted to regulatory authorities in the USA, Europe, and Japan has been defined within the International Conference o
It refers to the parallel consultation between European Network for Health Technology Assessment (EUnetHTA) and the European Medicines Agency (
Individual Parallel Consultations are supported by the EUnetHTA ED Secretariat, thereby benefiting from HTA scientific and administrative coordination with centralised HTA recruitment, consolidated HTA comments and List of Issues, albeit with individual HTA written reports as the final product.
Regional and national HTA bodies provide recommendations on medicines and other health technologies that can be financed or reimbursed by the healthcare system in a particular Member State or region.
The Early Dialogues Working Party (EDWP) is a standing committee established by EUnetHTA to ensure robust high-quality HTA outputs. All EDWP members will participate in procedures selected for Consolidated Parallel Consultation.
The Early Dialogue Committee (EDC) is constituted for a specific product and the members will fluctuate to a degree for each Consultation. In the case of Consolidated Parallel Consultations, all EDWP members and a maximum of 3 other HTA members (from EUnetHTA WP5) will participate.
Products selected for this pathway will have an EDC composed of the EDWP members and up to 3 additional HTABs. Once the decision to proceed with a Consolidated Parallel Consultation has been taken, the EUnetHTA ED Secretariat begins the process of recruiting additional HTABs to compose the EDC.
A "medical device software”, refers to a computer application that meets the legal definition of a medical device and is not a part of any distinct product.