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Paper Topic:

Worldwide Regulatory Agencies

Running head : REGULATION OF DRUG DEVELOPMENT

World Wide Regulatory Agencies on Drug Development

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Abstract

The World Health Organization and the US Food and Drug Administration are some of the worldwide regulatory agencies responsible for the regulation of drug manufacture , distribution and production . Various laws mandate Clinical Resource Outsourcing in to monitor the ever growing and complicating pharmaceutical industry . Examples of such laws include HYPERLINK "http /www .archive .official-documents .co .uk /document /hoc /321 /321-xa .htm " \t "_blank " Animals (Scientific Procedures ) Act of 1986

, HYPERLINK "http /www .fda .gov /cder /guidance /GMP 20Phase1IND61608 .pdf " Guidance for Industry on CGMP for Phase 1 Investigational Drugs and Federal Food , Drug and Cosmetic Act to name a few

World Wide Regulatory Agencies on Drug Development

The field of pharmacology has grown complicated in the past years Pharmaceutical companies have become larger , procedural processes are more complex and clinical trials have become more decentralized and outsourced . To govern and regulate this field in health care , there are several worldwide and local agencies that exist as regulating bodies Examples of such organizations include the World Health Organization (WHO , the U .S . Food and Drug Administration (FDA ) and the U .K Medicines and Healthcare Products Regulatory Agency (MHRA ) to name a few

The main goal of these agencies is to promote public health by ensuring the quality , safety and efficacy of medicines available in the market This is accomplished through dissemination of information necessary for rational use of medicines monitoring of...

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