European Medicines Evaluation Agency EMEA

Fig. 2 Scheme of the tiered approach of the European Medicines Evaluation Agency (EMEA) for environmental risk assessment... 

European Medicines Evaluation Agency (EMEA) home page... 

European Medicines Evaluation Agency (EMEA) (2003), Good Manufacturing Practices, Chapter 4 Building and facilities, EMEA. 

Bioavailability According to the European Medicines Evaluation Agency (EMEA), bioavailability (F%) is the rate and extent to which an active moiety is absorbed from a pharmaceutical form, and becomes available in the systemic circulation. As a parameter, there are two types of bioavailability ... 

The release of a new drug onto the market must be approved by the regulating authority for that country. For example, in Britain this is the Medicines Control Agency (MCA), in the European Union it is the European Medicines Evaluation Agency (EMEA) and in the USA the US Food and Drugs Administration (FDA). These bodies, which are essentially consumer protection agencies, issue a so called product licence or marketing authority (MA) when they are satisfied... 

European Medicines Evaluation Agency (EMEA) Guideline. Production and Quality Control of Monoclonal Antibodies, Directive 75/318/EEC, 1995. http // www.q-one.com/guidance/emea.htm... 

All vaccines European Medicines Evaluation Agency (EMEA) notes for guidance of preclinical pharmacological and toxicological testing of vaccines 1997... 

Committee on Proprietary Medicinal Products (CPMP) A committee, composed of two people from each EU Member State (see European Union (EU) ), that is responsible for the scientific evaluation and assessment of marketing applications for medicinal products in the EU. The CPMP is the major body involved in the harmonization of pharmaceutical regulations within the EU and receives administrative support from the European Medicines Evaluation Agency. See European Medicines Evaluation Agency (EMEA). ... 

Such as the European Medicines Evaluation Agency (EMEA), or the British Medicines Control Agency (MCA) and Committee on Safety of Medicines (CSM), or Italy s Pharmaceutical Commission. Throughout the book, general references to the FDA imply or other international regulatory body. ... 

This is an area of significant advancement for industrial chemical notification and registration where several in vitro techniques have been legislated in favor of animal tests in certain scenarios or take their place in tier-testing strategies. The European Medicines Evaluation Agency (EMEA) has also taken a positive stand on the replacement of animal studies by in vitro methods. 

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