pharmaceutical regulatory guideline
C46327
concept
A pharmaceutical regulatory guideline is an authoritative document that defines the standards, requirements, and procedures that pharmaceutical products must meet to be developed, tested, approved, manufactured, and monitored to ensure their quality, safety, and efficacy.
Observed surface forms (2)
- U.S. generic drug regulatory concept ×1
- drug approval process ×1
Instances (3)
- ICH Q3A Impurities in New Drug Substances
- Abbreviated New Drug Application process via concept surface "drug approval process"
- Paragraph I certification via concept surface "U.S. generic drug regulatory concept"