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

Table. 1.

Table. 1.

Definition of Regulatory Science

Institute Definition of Regulatory Science
FDA The science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products.

PMDA12) The science aimed at the optimal introduction into society of new products of science, such as discovered substances and new scientific tools and technologies as well as knowledge and information.

EMA The range of scientific disciplines that are applied to the quality, safety and efficacy assessment of medicinal products and that inform regulatory decision making throughout the lifecycle of a medicine

MEB13) The science of developing and validating new standards and tools to evaluate and assess the benefit/risk of medicinal products, facilitating sound and transparent regulatory decision making.

CORS14) The science that informs, facilitates and/or evaluates regulatory decision making.

FDA; Food and Drug Administration, PMDA: Pharmaceuticalas and Medical Devices Agency

EMA: European MEdicines Agency, MEB: Medicines Evaluation Board

CORS: Copenhagen Centre for Regulatory Science

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