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

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

研究成果: Article査読

抄録

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 Results: By November 2020, the draft guidance paper was completed and sent to the related organizations, 17 of which provided a total of 156 comments.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

本文言語English
ページ(範囲)829-839
ページ数11
ジャーナルInternational Journal of Clinical Oncology
27
5
DOI
出版ステータスPublished - 2022 5月

ASJC Scopus subject areas

  • 外科
  • 血液学
  • 腫瘍学

フィンガープリント

「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」の研究トピックを掘り下げます。これらがまとまってユニークなフィンガープリントを構成します。

引用スタイル