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Review the role and functions of the European Medicines agency (EMA) in the context of biotechnology drugs - Essay Example

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The EMA has adopted the decentralized system of organization and corporation with other regulatory bodies. Their main concern is protecting…
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Review the role and functions of the European Medicines agency (EMA) in the context of biotechnology drugs
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"Review the role and functions of the European Medicines agency (EMA) in the context of biotechnology drugs"

Download file to see previous pages These include herbal medicine, biologics and advanced therapies in relation to human and veterinary therapies (European Medicines Agency. 13 September 2011).
The agency is made up of a Secretariat (ca. 600 staff), a board of management, a total of 6 scientific committees (human, herbal and veterinary products, orphan drugs, pediatrics and advanced therapies) and a number of scientific working parties (European Medicines Agency. 13 September 2011).The organization is well structured into five units which are mutually related to each other in terms of operation and services. The EMA derives its resources from over forty National Competent Authorities and over 4500 experts from all over European Union countries(European Medicines Agency. 13 September 2011).
Although the Community pharmaceutical legislation is based essentially on the Single Market provisions of the EU Treaty, the primary stakeholders obviously include patients and healthcare professionals who operate in quit different healthcare delivery systems (HMA Strategy Paper, 2007). While maintaining regular checks on the manufacturing of biotechnological products, the EMA agency provides for relevant advice to the pharmaceutical companies and caters for the public interest. The field of medicine is very sensitive area since it embodies the life of an individual and animals as well. Therefore, there has been a need to provide quality assessment in the medicinal field in order to ascertain safety, efficiency and quality in the process of manufacturing pharmaceuticals(HMA Strategy Paper, 2007).
These requires detailed assessment by external body (EMA) which acts as autonomous body capable of carrying out its activities without the influence or engagement of political entities. Medicines are meant to improve quality of life; any deviation to the expected standards of requirement has devastating effect on the human and animal health. The European Medicine Agency therefore takes ...Download file to see next pagesRead More
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