1. 1) Guidelines for toxicity studies on drugs required for applications for approval to manufacture (or import) a drug (PAB Notification No. 24), 1989.
2. 2) Guidelines for single-dose and repeated-dose toxicity studies (PAB Notification No. 88), 1993.
3. 3) Amendment to a part of guidance for repeated-dose toxicity studies (PMSB Notification No. 655), 1999.
4. 4) Detection of toxicity to reproduction for medicinal products (PAB Notification No. 470), 1994.
5. 5) Toxicity to male fertility an addendum to the ICH tripartite guideline on detection of toxicity to reproduction for medicinal products (PAB Notification No. 316), 1997.