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The European Medicines Agency (EMA) operates as a decentralised scientific agency (as opposed to a regulatory authority) of the European Union (EU) and its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. [8]
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.
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efficacy and safety criteria), and also the circumstances where a marketing authorisation already granted may be withdrawn, suspended or revoked.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]
As Canadians, Britons and Americans begin getting immunized with a German-developed vaccine against coronavirus, pressure is building on the European Medicines Agency to approve the shot made by ...
Marketing Authorisation Application (MAA) is an application submitted by a drug manufacturer seeking marketing authorisation, that is permission to bring a medicinal product (for example, a new medicine or generic medicine) to the market.
Bringing Drugs to Market One of the primary roles of a pharmaceutical physician is to shepherd new drugs through the clinical trial process, from initial concept to market. This involves several phases of clinical testing to demonstrate a drug's safety and efficacy before it can be submitted for regulatory approval.
The FDA will review the nasal spray again and is expected to decide on its approval by Oct. 2. William Blair analyst Tim Lugo said the EU recommendation bodes well for a FDA approval.
The European Committee on Cosmetics and Consumer Health (CD-P-COS) [34] is tasked with responding to emerging risks for health arising from the use of cosmetics. By promoting the principles laid down in Council of Europe Resolution ResAP(2008)1 on requirements and criteria for the safety of tattoos and permanent make-up, [ 35 ] the committee ...