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The Common Technical Document (CTD) is a set of specifications for an application dossier for the registration of medicine, designed for use across Europe, Japan, the United States, and beyond. [ 1 ] Major Synopsis
Such submission is a mandatory part of the registration process. Under certain circumstances the performance of a chemical safety assessment (CSA) is mandatory and a chemical safety report (CSR) assuring the safe use of the substance has to be submitted with the dossier. Dossier submission is done using the web-based software REACH-IT.
Duration of the examination varies according to the complexity and the clarity of the dossier. Committees however have the obligation to deliver their first opinion on the dossier 10 months after its submission at the latest. The dossier with the Committee's opinion is then sent to the Commission. The whole process can take up to 2 years.
On May 5, 2015, the U.S. Food & Drug Administration published a final, binding guidance document [7] requiring certain submissions in electronic (eCTD) format within 24 months. The projected date for mandatory electronic submissions is May 5, 2017 for New Drug Applications (NDAs), Biologic License Applications (BLAs), Abbreviated New Drug ...
Volume 2B deals with the presentation and content of the application dossier. Volume 2C deals with Guidelines. ... News on Pharmaceuticals, (European Union) EudraLex;
The application dossier for marketing authorisation is called a New Drug Application (NDA) in the USA or Marketing Authorisation Application (MAA) in the European Union and other countries, or simply registration dossier. This contains data proving that the drug has quality, efficacy and safety properties suitable for the intended use ...
A centralised marketing authorisation, issued by the European Commission, allows the holder to market a medicinal product throughout the European Economic Area (EEA), which comprises the EU Member States, Iceland, Norway and Liechtenstein. [2] In the United States, the equivalent process is called New Drug Application.
The Guidelines for Examination in the European Patent Office (or, for short, the EPO Guidelines) are general instructions, for the examiners working at the European Patent Office (EPO) as well as for the parties interacting with the EPO, [notes 1] on the practice and procedure at the EPO in the various aspects of the prosecution of European patent applications and European patents.