Toxicology

Links to major regulatory information of Toxicology.
 

Regulations and Notifications

Clinical Trial Notification Review

• Points to Consider for nonclinical safety matters when submitting the initial clinical trial notification (Early Consideration) [97KB]

　 March 25, 2025 Office of Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency
 

Reviews and Consultations

• Thoughts on the Use of Weight of Evidence Approach in Nonclinical Safety Evaluation(Early Consideration) [199KB]

　 October 24, 2025 Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency
 

• Use of the Weight of Evidence approach as an alternative to nonhuman primate developmental and reproductive toxicity testing for biopharmaceuticals(Early Consideration) [288KB]

　October 24, 2025 Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency
 

• Points to consider for the discussion with PMDA using the ICH S1B (R1) guideline and in the approval application (Early Consideration) [115KB]

　 March 24, 2025 Office of Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency

 

Oligonucleotide therapeutics

• Guideline for preclinical safety assessment of oligonucleotide therapeutics[291.92KB]

March 30, 2020 PSEHB/PED Notification No. 0330-1

 

Cancer Immunotherapy

• Guidelines on Cancer Immunotherapy Development[901.47KB]

March 8, 2019 PSEHB/PED Notification No. 0308-1　PSEHB/MDED Notification No.0308-1

 

Gene Therapy Products

• Guidelines on ensuring quality and safety of gene therapy products

 

Related Links

Vaccines and Blood Products

• Vaccines Against the Novel Coronavirus SARS-CoV-2

First in Human Studies

• First in Human Studies

Nanomedicines

• Nanomedicine