pISSN 1226-6051
eISSN 2508-786X

Table. 4.

Table. 4.

Main services of the regulatory science center

Main task Example of outcomes
1. Providing services on cutting-edge technology
- Science Board*, Horizon scanning
• Theme of Science Board (4th ~March, 2020) :
- Subcommittee of Genome Editing: The risk assessment of genome edited products36)
• Horisozn scanning : PMDA led the international project Under ICMR37)
2. Promoting use of submission data/real-world data(RWD)
- Analysis of Clinical Data Interchange Standards Consortium(CDISC) Data Submitted with New Drug Application
- Assessment of benefit/risk of drugs based on real world data (RWD)
• Case example of analysis with e-data
- PopPK analysis using Japanese population and non-Japanese population data38)
• RWD : Clinical Innovation Network(CIN),39), The Medical Information Database Network(MID-NET)40)
3. Human resource development
- Exchange of expertise between academia and PMDA staff
• Collaborative graduate school program
• Comprehensive cooperation agreement

ICMRA, International Coalition of Medicines Regulatory Authorities; PopPK, Population Pharmacokinetic

*Science Board: high-level consultative body which discusses scientific aspects of pharmaceuticals, medical devices and regenerative medical products review in PMDA

Korean J Clin Pharm 2021;31:257-67 https://doi.org/10.24304/kjcp.2021.31.4.257
© 2021 Korean J Clin Pharm