International Comparison of Contraceptive Informationin the Package Insert

Abstract

Regulations on drug package inserts in Japan, Europe, and the United States are controlled by the regulatory authorities of each country. The equivalent of drug package inserts in Japan is treated as SmPC in Europe and Labeling in the United States. Regarding the content of information on contraception in this package insert, it was found that there are differences in the content in Japan, Europe and the United States. It was also found that even if there is a specific description of the contraceptive period in the overseas package insert, there is a poorly specific description of “contraception for a certain period” in the domestic package insert. In the United States, “Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations Guidance for Industry” was issued in May 2019, calling attention to specific contraceptive periods based on the half-life of blood levels for each drug. It is considered necessary to describe the specific period in the description of the contraceptive period in the package insert in Japan.