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The European Union Drugs Agency (EUDA), known until 2024 as the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA), is an agency of the European Union headquartered in Lisbon, Portugal, and established in 1993. In June 2022, [4] the Council of the European Union approved a reform of the organization which lead to an extension of ...
Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. It repealed Directive 93/42/EEC on Medical Devices (MDD), and Directive 90/385/EEC, which concerns active implantable medical device. The regulation was published on 5 April 2017 and came into force on 25 May ...
v. t. e. The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA). [4][5] The EMA was set up in 1995, with funding ...
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 European regulatory authorities update the database continuously and expect it to grow extensively over the next few years as more “GMP certificates are imported each year.” [2] The database serves as a quick reference for checking the good manufacturing practice (GMP) of a potential contract manufacturer.
The CTD is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries. It was developed by the European Medicines Agency (EMA, Europe), the Food and Drug Administration and the Ministry of Health, Labour and Welfare (Japan ...
EudraCT. EudraCT (E uropean U nion D rug R egulating A uthorities C linical T rials) is the European clinical trials database of all clinical trials of investigational medicinal products with at least one site in the European Union commencing 1 May 2004 or later. The EudraCT database has been established in accordance with Directive 2001/20/EC.
EudraLex consists of 10 volumes: Concerning Medicinal Products for Human use: Volume 1 - Pharmaceutical Legislation. Volume 2 - Notice to Applicants. Volume 2A deals with procedures for marketing authorisation. Volume 2B deals with the presentation and content of the application dossier. Volume 2C deals with Guidelines.