Regulatory agencies European Medicines Agency

It was through this series of, now codified, Directives that a Europe-wide Committee for Proprietary Medicinal Products was created, now known as the Committee for Medicinal Products for Human Use (CHMP). Its role is significant. In conjunction with the European Medicines Agency (EMEA) established in February 1995, which it advises, it is responsible for overseeing the procedures established for the regulatory harmonization of pharmaceutical products throughout Europe, namely ... 

The Committee was informed by the European Medicines Agency (EMEA) of a proposed approach to facilitate inspections and to avoid duplication of inspections. A GMP database was being established in the European Union by Member States that would provide information on and outcome of inspections. The database was expected to be released in 2006. Access rights were being discussed with WHO, the Pharmaceutical Inspection Cooperation Scheme (PIC/S), the European Directorate for the Quality of Medicines (EDQM) and other organizations. Different levels of access will exist including one for public access and others for national medicine regulatory authorities, WHO and PIC/S. 

Approval by the regulatory authorities, such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA), as having clinical advantages over current treatments and a suitable safety prohle. 

S., Patel, Hasmukh B., Powers, Roslyn F., and Yu, Lawrence, Pharmaceutical impurities regulatory perspective for abbreviated new drug apphcations. Advanced Drug Delivery Reviews, 59, 64—72, 2007. Guidance issued by the EMEA (European Medicines Agency, Evaluation of Medicines for Human Use, London, June 23, 2004. See also Reference 6. 

The European Medicines Agency (EMEA) is a decentralized body of the European Union created with the objective to harmonize regulatory activities in Europe. EMEA began its activities in 1995, when the European system for authorizing medicinal products was introduced, providing for a centralized and a mutual recognition procedure. 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. 

European Medicines Agency. Benefit-risk methodology project work package 2 report applicabUity of current tools and processes for regulatory benefit-risk... 

European Medicines Agency. Human regulatory. Herbal products. http //www.ema.europa.eu. Accessed 7 Jul 2014... 

QRD Recommendations on the expression of strength in the name of centrally authorised human medicines. European Medicines Agency, London. htttp //www.ema.europa.eu/docs/en GB/docu ment library/Regulatory and procedural guideline/2010/01/ WC500056428.pdf. Accessed 16 Mar 2013... 

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