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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
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 ...
Eudralex,The Rules Governing Medicinal Products in the European Union, European Communities Commission. Directorate-General for Industry, Pharmaceuticals and Cosmetics. Vol. 1: Pharmaceutical legislation: medicinal products for human use.
The European Network for Health Technology Assessment (EUnetHTA) supports collaboration between several European HTA organizations. EUnetHTA Guidelines have been developed to help the assessors of evidence to process, analyse and interpret the data. EUnetHTA: Endpoints used for Relative Effectiveness Assessment Clinical Endpoints. [42]
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 ...
The single submission process for approval to conduct research in all EU member states is facilitated by the Clinical Trials Information System (CTIS). [3] CTIS is an online portal which enables interactions between clinical trial sponsors (that is, the organization responsible for the conduct of the clinical trial), and the regulatory ...
Official Medicines Control Laboratory (OMCL) is the term coined in Europe for a public institute in charge of controlling the quality of medicines and, depending on the country, other similar products (for example, medical devices). They are part of or report to national competent authorities (NCAs).
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.