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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.
Directive 75/319/EEC, requires marketing authorization requests to be drawn up only by qualified experts; Directive 93/41/EEC, establishes the European Agency for the Evaluation of Medicinal Products; Directive 2001/20/EC, defines rules for the conduct of clinical trials; Directive 2001/83/EC
In most countries, a marketing authorisation is valid for a period of 5 years. After this period, one should apply for renewal of the marketing authorisation, usually by providing minimal data proving that quality, efficacy and safety characteristics are maintained and the risk-benefit ratio of the medicinal product is still favourable.
EMA/199678/2016: Reflection paper on extrapolation of efficacy and safety in paediatric medicine development. [8] EMA/189724/2018: Reflection paper on the use of extrapolation in the development of medicines for paediatrics. [9] EMA/129698/2012: Concept paper on extrapolation of efficacy and safety in medicine development. [10]
The European Commission granted European market authorization on August 30, 2012 for the medicinal product teduglutide (trade name in Europe: Revestive ®) as a once-daily treatment for adult ...
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 ).
Expanded access or compassionate use is the use of an unapproved drug or medical device under special forms of investigational new drug applications (IND) or IDE application for devices, outside of a clinical trial, by people with serious or life-threatening conditions who do not meet the enrollment criteria for the clinical trial in progress.
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.