"Points to consider" regarding safety assessment of biotechnology-derived pharmaceuticals in non-clinical studies (English translation).

Regulatory and industrial scientists collaborated to publish a points to consider document regarding the safety assessment of biotechnology-derived pharmaceuticals in non-clinical studies in 2002 (Pharmaceutical Non-clinical Investigation Group, 2002). The collaboration team intended to clarify the interpretation of ICH-S6 guideline and furthermore share recent Japanese practices on this matter. However, the document was written in Japanese. Thus, we share here an English translation of the document so that non-native Japanese correctly understand the contents.