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]
March 24, 2025 Office of New Drug I, Pharmaceuticals and Medical Devices Agency
Category 2
[Pulmonary Arterial Hypertension]
January 7, 2025 Office of New Drug II, Pharmaceuticals and Medical Devices Agency
[Cardiac Amyloidosis]
December 26, 2024 Office of New Drug II, Pharmaceuticals and Medical Devices Agency
Category 3-1
[Psychotropic Drugs]
August 15, 2024 Office of New Drug Ⅲ, Pharmaceuticals and Medical Devices Agency
Category 4
[Antibacterial Drugs]
October 23, 2017 PSEHB/PED Notification No. 1023-3
Category 6-1
[Palmoplantar Pustulosis]January 23, 2025 Office of New Drug IV, Pharmaceuticals and Medical Devices Agency
Category 6-2
[Oral Hypoglycemic Agents]
July 9, 2010 PFSB/ELD Notification No. 0709-1
July 9, 2010 PFSB/ELD Administrative Notice
Radiopharmaceuticals
[Diagnostic Radiopharmaceuticals]
June 11, 2012
Oncology Drugs
[Antineoplastic Drugs]
December 10, 2024
December 4, 2024 Office of Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency
[Cancer Immunotherapy]