Reviews and Related Services

Toxicology

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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

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