임신⋅수유 중 약물 표기 규정의 변화

Changes of Labelling Regulation in Pregnancy and Lactation

Objectives: To examine drug labelling policy changes in pregnancy and breastfeeding is helpful to promote Korean drug policy. Methods: Historical analysis and investigation was selected for show changes of drug labelling. And new changes of FDA in 2015 should be described in contents and meanings of proposition. Results & Discussions: Reproduction toxicity test became necessary to submit the data in drug development process. Drug information in Pregnancy and lactation based on various case and clinical research, reproductive toxicity test data, and safety information can be formed. Pharmaceutical Safety labelling during pregnancy and lactation is helpful when choosing their medicines and medical personnel. New guide from US FDA in 2015 can tell clinical meaning above 5 grades classification and explain scientific data more in detail. Conclusions: To manage confusion of drug labelling, international efforts to improve prenatal medicine should be continued to reflect in policies.