pharmaceutical law
C21773
concept
Pharmaceutical law is the body of legal rules and regulations governing the research, development, approval, manufacturing, marketing, distribution, and use of drugs and medical products to ensure their safety, efficacy, and ethical oversight.
Observed surface forms (5)
- orphan medicinal products legislation ×2
- pharmaceutical regulatory standard ×2
- Hatch-Waxman certification ×1
- drug regulation law ×1
- medicines legislation ×1
Instances (11)
- Drug Price Competition and Patent Term Restoration Act of 1984
- Norwegian Medicines Act via concept surface "medicines legislation"
- Regulation (EC) No 141/2000 on orphan medicinal products via concept surface "orphan medicinal products legislation"
- Regulation (EC) No 141/2000 via concept surface "orphan medicinal products legislation"
- ICH CTD via concept surface "pharmaceutical regulatory standard"
- Common Technical Document via concept surface "pharmaceutical regulatory standard"
- Regulation (EC) No 1394/2007
- Paragraph I certification via concept surface "Hatch-Waxman certification"
- FDAMA
- Public Law 98-417
- FDAAA via concept surface "drug regulation law"