Pharmaceutical Regulation
Pharmaceutical regulation is a system of laws and standards that governs the development, approval, manufacturing, and distribution of pharmaceutical products to ensure their safety, efficacy, and quality.
5.1K
Publications
215.1K
Citations
12.2K
Authors
3.7K
Institutions
Publications per year
2017–2026
1.3K
5.1K
THE UNITED STATES PHARMACOPEIAL CONVENTION
A. D. Hirschfelder · JAMA · 1930 · 1K citations
The United States Pharmacopeial Convention
New England Journal of Medicine · 1910 · 916 citations
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12.2K
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London School of Economics and Political Science, United Kingdom
28 publications · 2.1K citations
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3.7K
Harvard University
Cambridge, United States
46 h-index
229 publications
12.2K citations
United States Food and Drug Administration
Silver Spring, United States
40 h-index
277 publications
18.1K citations
Center for Drug Evaluation and Research
Silver Spring, United States
35 h-index
230 publications
15.4K citations

Brigham and Women's Hospital
Boston, United States
35 h-index
180 publications
8.8K citations
London School of Economics and Political Science
London, United Kingdom
34 h-index
99 publications
5.3K citations
Yale University
New Haven, United States
30 h-index
90 publications
5.3K citations
Duke University
Durham, United States
29 h-index
75 publications
4.7K citations
KU Leuven
Leuven, Belgium
28 h-index
99 publications
7.4K citations
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Repository · 310 publications · 10.9K citations
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NEJM · 107 publications · 7.5K citations
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83 publications · 4.5K citations
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82 publications · 5.5K citations
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77 publications · 2.9K citations
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See also Pharmaceutical Regulation | |
|---|---|
Approval Pathways | Breakthrough Therapy Strategy Priority Review Regenerative Medicine Expanded Access Use Premarket Approval |
Safety Monitoring | Pharmacovigilance Adverse Drug Reaction Reporting Signal Detection Risk Assessment Post-market Surveillance Passive Pharmacovigilance |
Manufacturing Standards | Good Manufacturing Practice Computerized System Validation Equipment Qualification Deviation Management Corrective Action Critical Quality Attributes Critical Process Parameters Process Analytical Technology Pharmaceutical Quality Assurance |
Clinical Evidence | Good Clinical Practice Investigational Device Exemptions In Vitro Diagnostic Regulation Audit Trails Trial Registries |
Labeling Control | |