PMDAジョイントシンポジウム1：我が国における神経疾患治療薬開発の多面的な展開
適切な医薬品開発推進のためのPMDAにおける最近の取組み
キーワード:
regulatory science,
innovative drug development,
global clinical trial,
electronic data utilization
2018 年 34 巻 4 号 p. 441-443
詳細
2018 年 34 巻 4 号 p. 441-443
Pharmaceuticals and Medical Devices Agency (PMDA) has been working to promote a proper drug development by academia and venture capital through consultation on R&D strategy. To promote an international harmonization in global drug development, PMDA proposed to establish a new international guideline focusing on multi–regional clinical trials and E17 guideline is currently under discussion in ICH. Recently, electronic data have been actively been utilized in review and safety assessment. Further challenges will continue for conducting appropriate review and safety measure of drugs as well as for promoting drug development.
