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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.
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 ).
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efficacy and safety criteria), and also the circumstances where a marketing authorisation already granted may be withdrawn, suspended or revoked.
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 ...
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate and partial agreement of the Council of Europe that traces its origins and statutes to the Convention on the Elaboration of a European Pharmacopoeia (an international treaty adopted by the Council of Europe in 1964: ETS 50, [2] Protocol [3]).
BioMarin Pharmaceutical Inc. (BMRN), a global biotechnology company received the European Medicines Agency (EMA) approval for accelerated assessment of valoctocogene roxaparvovec. BioMarin’s ...
Once the U.S. has a process in place, it could open a market worth $10 billion in the next decade, according to IMS Health. The FDA has no deadline for coming up with its own approval pathways.
EudraGMP is the database of the European Community of manufacturing authorisations and of certificates of good manufacturing practice.The EudraGMP system was launched in April 2007, for use by European Medicines Regulators.