A PHARMACOEPIDEMIOLOGICAL STUDY OF NEW DRUG APPROVAL PATTERN OF JAPAN

Objectives: The objective of the study was to study the drug development and drug approval pattern of a developed Asian country: Japan. Methods: Data available on official website of Japan government health authority was compiled for the duration of January 2017–December 2021. The new approved drugs were classified based on different parameters such as active ingredient, drug approval date, review category, new approval or partial change, Indication of drugs, and WHO anatomic thoracic classification. The descriptive analysis of data was done using LibreOffice Calc. Results: Out of 545 drugs approved, 46% were anti-neoplastic and immunomodulating agent, 10% were anti-infective and 9% were Nervous system category. Furthermore, among all approved drugs, 51.38% were new approved drugs while 48.62% of drugs were approved with partial change in dosage, route, or indications. Conclusion: This study showed new drug development and approval was done significantly for anti-cancer agents and agents for non-communicable diseases.