New Drugs（based on the review categories）

Links to major regulatory information of new drugs by review category.
 

Regulations and Notifications

New Drugs（based on the review categories）

(Note) Click the category below to move to the relevant item.

Category 1：Gastrointestinal drugs, dermatologic drugs, immunosuppressive drugs, and others (not classified as other categories)

Category 2：Cardiovascular drugs, antiparkinsonian drugs, anti-Alzheimer's drugs

Category 3-1：Central/peripheral nervous system drugs (excluding anesthetic drugs)

Category 4：Antibacterial drugs, antiviral drugs (excluding AIDS drugs), antifungal drugs, antiprotozoal drugs, anthelmintic drugs

Category 6-1：Respiratory tract drugs, anti-allergy drugs (excluding dermatologic drugs), sensory organ drugs for inflammatory diseases

Category 6-2：Hormone drugs, drugs for metabolic disorders(including diabetes mellitus, osteoporosis, gout, and inborn errors of metabolism)

Radiopharmaceuticals：Radiopharmaceuticals

Oncology drugs： Antineoplastic drugs

Category 1

[Inflammatory Bowel Disease]

• Points to Consider in Developing Drugs for Pediatric Inflammatory Bowel Disease (Early Consideration)[63KB]

March 24, 2025 Office of New Drug I, Pharmaceuticals and Medical Devices Agency

Category 2

[Pulmonary Arterial Hypertension]

• Consideration in the development of drugs for pulmonary arterial hypertension (Early Consideration)[168KB]

January 7, 2025 Office of New Drug II, Pharmaceuticals and Medical Devices Agency

[Cardiac Amyloidosis]

• Points to consider in the clinical development of drugs for transthyretin amyloid cardiomyopathy (Early Consideration)[98.4KB]

December 26, 2024 Office of New Drug II, Pharmaceuticals and Medical Devices Agency

Category 3-1

[Psychotropic Drugs]

• Points to Consider for the Design of Clinical Trials to Assess the Effects of Psychotropic Drugs on Driving Performance (Early consideration)[175KB]

August 15, 2024 Office of New Drug Ⅲ, Pharmaceuticals and Medical Devices Agency

 

Category 4

[Antibacterial Drugs]

• Guideline for Clinical Evaluation of Antibacterial Drugs[906.39KB]

October 23, 2017 PSEHB/PED Notification No. 1023-3

Category 6-1

[Palmoplantar Pustulosis]

• Points to Consider for Clinical Efficacy Evaluation of Drugs for Palmoplantar Pustulosis (Early consideration)[178KB]

January 23, 2025 Office of New Drug IV, Pharmaceuticals and Medical Devices Agency

Category 6-2

[Oral Hypoglycemic Agents]

• On Release of the Guideline for Clinical Evaluation of Oral Hypoglycemic Agents[156.49KB]

July 9, 2010 PFSB/ELD Notification No. 0709-1

 

• On Release of Questions and Answers (Q&As) regarding the Guideline for Clinical Evaluation of Oral Hypoglycemic Agents[73.82KB]

July 9, 2010 PFSB/ELD Administrative Notice

Radiopharmaceuticals

[Diagnostic Radiopharmaceuticals]

• Considerations for Non-Clinical Studies in the Development of Diagnostic Radiopharmaceuticals (Early Consideration [126.12KB]

March 26, 2025 Office of New Drug II, Pharmaceuticals and Medical Devices Agency

• Guideline for Clinical Evaluation of Diagnostic Radiopharmaceuticals[286.37KB]

June 11, 2012 PFSB/ELD Notification No. 0611-1

Oncology Drugs

[Antineoplastic Drugs]

• Check List for 30-day-Clinical Trial Notification Review on an Initial Clinical Trial Notification (Oncology Drugs)[241KB]

December 10, 2024

 

• Statistical Considerations When Planning Phase I Clinical Trials in Oncology - From the Safety Perspective (Early consideration) [197KB]

December 4, 2024 Office of Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency

[Cancer Immunotherapy]

• Guidelines on development of cancer immunotherapy