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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 ).
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.
Like ordinary EMA marketing authorisations, a PUMA approval is valid in all countries of the European Economic Area (the European Union as well as Iceland, Liechtenstein, and Norway). The PUMA process was established to make it more profitable for pharmaceutical companies to market drugs for children.
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Biovest Conducts Meeting with EMA Advancing Process to Seek EU Approval for Cancer Vaccine Key Contributor to Human Genome Project Joins Scientific Advisory Board TAMPA, Fla. & MINNEAPOLIS ...
BioMarin Pharmaceutical Inc. (BMRN), a global biotechnology company received the European Medicines Agency (EMA) approval for accelerated assessment of valoctocogene roxaparvovec. BioMarin’s ...
This process is performed within a legal framework defining the requirements necessary for successful application to the regulatory authority, details on the assessment procedure (based on quality, efficacy and safety criteria), and also the circumstances where a marketing authorisation already granted may be withdrawn, suspended or revoked. [1]
The public database allows the general public access to information regarding manufacturing inspections completed by regulatory authorities from all European Economic Area (EEA) countries. Prior to the enactment of the EudraGMP database, information only came from a limited number of European countries.