A Study on the Current Regulations of Statistics for Pharmaceutical Products in Taiwan
Date Issued
2009
Date
2009
Author(s)
Chen, Jin-Nan
Abstract
In registration of medicine, if there is no adequate and feasible statistical principles in the regulation requirements, the pharmaceutical industry will be in a maze and the people health will not be safeguarded. For this reason, it is essential to establish a statistical principles for medicine to ensure that the criteria of quality, safety, and efficacy are met for the new treatments for the patients in need. Therefore, this thesis surveyed the structure and regulations about statistical principles in the jurisdiction for the Bureau of Pharmaceutical Affairs, Department of Health, Taiwan for registration of a drug. The comparative law approach was adopted in the methodology. By examining the ICH and the regulatory agencies of Europe, Japan and the USA, we concluded that it is essential in our government to establish an adequate unit, draw up feasible legislations and technical requirements, and recruit biostatistical experts. Finally, we attempted to provide suggestions about the possible improvement of regulations in applications of statistics to registration of pharmaceutical products.
Subjects
statistics
medicine product
ICH
CDER
PMDA
EMEA
Type
thesis
File(s)![Thumbnail Image]()
Loading...
Name
ntu-98-R94621207-1.pdf
Size
23.32 KB
Format
Adobe PDF
Checksum
(MD5):8aeeca3bec73e75ff5c214e26b4407a5