Pediatric Formulations Study Group Outputs Dosage Form Classification and Nomenclature for Mini-Tablets
The Formulation Research Subcommittee established the Pediatric Formulations Study Group with the aim of organizing the dosage forms, names, and quality control concepts related to mini-tablets, which are currently being developed as pediatric formulations (activities are conducted in collaboration with the Pediatric Formulations Focus Group of the Japanese Society of Pharmaceutical Sciences and JPMA).
In recent years, small granular tablets (commonly known as “mini-tablets”), developed to improve ease of administration for children (including infants and toddlers), have been developed and marketed overseas and are beginning to gain popularity in Japan as well. While mini-tablets are sometimes treated the same as standard tablets, depending on their dosage and administration instructions, they may be treated similarly to granules.Furthermore, in Japan, there are various notations used for the product names of mini-tablets, and there is currently no document outlining the principles for naming them or clarifying the relationship between their names and dosage form classifications. For this reason, it is considered important to establish a common understanding regarding the handling and quality control of mini-tablets not only among pharmaceutical companies but also among stakeholders, including healthcare professionals.Against this backdrop, the Pediatric Formulations Focus Group of the Pharmaceutical Society of Japan (a public interest incorporated association), the Japan Pharmaceutical Manufacturers Association (to be reorganized as a general incorporated association in October 2026), Quality & Technology Committee’s Pharmaceutical Formulation Research Subcommittee’s Pediatric Formulations Review Group, and the Pharmaceutical Formulation Research Group of the JPMA have been working to clarify the approach to the dosage form classification and naming of mini-tablets, with the aim of fostering a common understanding among pharmaceutical companies and stakeholders, including healthcare professionals.In August 2025, they submitted the “Request Regarding the Dosage Form Classification and Naming of Mini-Tablets” to the Formulation Committee of the Japanese Pharmacopoeia Draft Review Committee at the Pharmaceuticals and Medical Devices Agency (PMDA).
We are pleased to inform you that we have received a response regarding dosage form classification from the Formulation Committee of the Japanese Pharmacopoeia Draft Review Committee, and both the request and the response have been posted on the Pharmaceuticals and Medical Devices Agency (PMDA) website (under “Technical Information (Background of Amendments, etc.),” Section 4: “Other Matters”).We hope that the results of this initiative will assist pharmaceutical companies in the development of mini-tablet products.
Regarding the method for assigning names, we are currently seeking input from the Pharmaceutical Evaluation and Management Division and the Pharmaceutical Safety Measures Division of the Ministry of Health, Labor and Welfare, which are the authorities responsible for approving drug trade names. We will provide further updates as developments occur.