약학회지
YAKHAK HOEJI
ISSN 0377-9556 (PRINT)
ISSN 2383-9457 (ONLINE)

Table. 5.

Table. 5.

Area of Focus in U.S. and Europe

Report Area of Focus
FDA (2011) Advancing Regulatory Science at FDA 1. Modernize Toxicology to Enhance Product Safety
2. Stimulate Innovation in Clinical Evaluations and Personalized Medicine to Improve Product Development and Patient Outcomes
3. Support New Approaches to Improve Product Manufacturing and Quality
4. Ensure FDA Readiness to Evaluate Innovative Emerging Technologies
5. Harness Diverse Data through Information Sciences to Improve Health Outcomes
6. Implement a New Prevention-Focused Food Safety System to Protect Public Health
7. Facilitate Development of Medical Countermeasures to Protect Against Threats to U.S. and Global Health and Security
8. Strengthen Social and Behavioral Science to Help Consumers and Professionals Make Informed Decisions about Regulated Product

FDA (2021) Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science (FARS) 1. Public Health Preparedness and Response
2. Increasing Choice and Competition through Innovation
3. Unleashing the Power of Data
4. Empowering Patients and Consumers

EMA (2020) Regulatory Science to 2025 1. Catalysing the integration of science and technology in medicines development
2. Driving collaborative evidence generation – improving the scientific quality of evaluations
3. Advancing patient-centered access to medicines in partnership with healthcare systems
4. Addressing emerging health threats and availability/therapeutic challenges
5. Enabling and leveraging research and innovation in regulatory science

FDA: Food and Drug Administration, EMA: European Medicines Agency

Yakhak Hoeji 2021;65:335-43 https://doi.org/10.17480/psk.2021.65.5.335
© 2021 Yakhak Hoeji