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The disarray in the regulatory approval process for introducing new medicines to patients around the world
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Mazahreh, Saman. The disarray in the regulatory approval process for introducing new medicines to patients around the world. Retrieved from https://doi.org/doi:10.7282/T30V8B2S

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TitleThe disarray in the regulatory approval process for introducing new medicines to patients around the world
NameMazahreh, Saman (author); Seiglie, Carlos (chair); Coate, Douglas (internal member); Spatareanu, Mariana (internal member); Sultzbaugh, Susan (outside member); Rutgers University; Graduate School - Newark
Date Created2014
Other Date2014-05 (degree)
SubjectGlobal Affairs, Drug approval, Drugs--Law and legislation
Extentxv, 148 p. : ill.
DescriptionThe pharmaceutical regulatory framework is a complex system requiring great diligence when requesting approval for a new medicine in different countries around the world. The hypothesis was that cost of an application for a new drug approval would play a major role in the country’s ability to review and approve a new drug. A study of the history of regulation, current gaps in the system, and regional harmonization efforts was conducted. Research and data collection on 129 countries was completed. Data included economic, development, political, and health indicators. Statistical analysis was conducted and some results confirmed part of the hypothesis while other results indicated that further study is needed. Stability of a government was confirmed to be a key factor in the drug approval process. The more stable the government, the more educated the population, the higher life expectancy because of increased access to medicine. As part of the research that led to the results above, it’s important to understand which governance structure is in place or needs to be installed? What are the next steps moving forward in gathering additional data from other companies, governments, and conducting a bigger research project that can confirm the results of this study? The World Health Organization, World Bank, International Monetary Fund, and other technical cooperative groups serve as forums that are collaborating to achieve better faster results. The term global affairs suggests that there are multiple subjects being discussed. The results of this paper imply and confirm that a multidisciplinary approach must be taken in order to enhance the current global pharmaceutical regulatory process.
NotePh.D.
NoteIncludes bibliographical references
NoteIncludes vita
Noteby Saman Mazahreh
Genretheses, ETD doctoral
Persistent URLhttps://doi.org/doi:10.7282/T30V8B2S
Languageeng
CollectionGraduate School - Newark Electronic Theses and Dissertations
Organization NameRutgers, The State University of New Jersey
RightsThe author owns the copyright to this work.
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