Guidance on the need for contraception related to use of pharmaceuticals: the Japan Agency for Medical Research and Development Study Group for providing information on the proper use of pharmaceuticals in patients with reproductive potential

• DOI: 10.1007/s10147-022-02149-1
• Publication Date: 2022-03-29T01:03:41Z
• Authors: Nao Suzuki; Yasushi Takai; Masahito Yonemura; Hiromitsu Negoro; Shinya Motonaga; Noriko Fujishiro; Eishin Nakamura; Seido Takae; Saori Yoshida; Koji Uesugi; Takashi Ohira; Aiko Katsura; Michio Fujiwara; Itsuko Horiguchi; Kenjiro Kosaki; Hiroshi Onodera; Hiroyuki Nishiyama
• Keywords: Guideline

Abstract Background The U.S. Food and Drug Administration (FDA) European Medicines Agency (EMA) have published guidelines on the use of cancer treatments in young people reproductive potential. However, no such guideline is available Japan. Therefore, this project aimed to gather relevant data draft a respective guidance paper. Methods From April 2019 March 2021, Study Group for Providing Information Proper Use Pharmaceuticals Patients with Reproductive Potential at Japan Medical Research Development gathered opinions from experts medicine, toxicology, drug safety measures. group considered these opinions, FDA EMA guidelines, Japanese prepared paper, which they sent 19 related organizations comment. Results By November 2020, paper was completed organizations, 17 provided total 156 comments. study finalized 2021. Conclusions “Guidance Need Contraception Related Pharmaceuticals” (The report Potential, Regulatory Science Devices, Development: JP20mk0101139) expected help healthcare professionals provide fertility-related care advice adolescents, adults their families.