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A policy to promote the use of generic medicines was initiated by the Japanese government in the early 2000s. Several bioequivalence and related guidelines have been published by the Evaluation and Licensing Division of the Pharmaceutical Safety and Environmental Health Bureau of The Japanese Ministry of Health, Labour, and Welfare (MHLW). The Guideline for Generic products covers all types of medicinal products and describe the procedures for a BE study. This “Fundamental Guideline” procedures are divided into two parts, dissolution testing and the in vivo BE study. Since publication of the previous chapter, the following changes have been made: A fed BE study has been required for solubility-enhanced IR and enteric coated formulations where, previously, a fasted study only was necessary. However, if the administration of the product requires it to be taken fasting, then a fed study is not required. If there is a significant difference in dissolution rate between the reference and test products, or if ethnic differences in gastrointestinal physiology including the level of gastric acidity are thought to affect the evaluation of BE due to formulation characteristics, a BE study in Japanese subjects is required. A further new requirement involves setting separate dissolution test conditions for solubility-enhanced IR formulations. For different strengths, the dissolution medium volume for the lower strength can be adjusted in the range 450–900 mL to achieve the same content per unit volume (the same dissolved concentration). A further change involves the statistical analysis relating to the adaption of additional data acquisition where the probability of a type 1 error is controlled instead of the previous method using the sum of data obtained in the pivotal study and an add-on subject study conducted separately from the pivotal study or a pilot study. It is noted that the recent ICH M13 guideline recommendations (“ICH Guidance: M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms, draft version, endorsed on December 20, 2022” [Online]. Available: https://www.fda.gov/media/165049/download . [Accessed 15 February 2024]) have not been considered for inclusion in the revised current Japanese BE study guideline issued in 2020.

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Japan

  • 章节

  • 发表日期：

    2025年

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  • Noriyuki Muranushi,
  • Juichi Riku

摘要

A policy to promote the use of generic medicines was initiated by the Japanese government in the early 2000s. Several bioequivalence and related guidelines have been published by the Evaluation and Licensing Division of the Pharmaceutical Safety and Environmental Health Bureau of The Japanese Ministry of Health, Labour, and Welfare (MHLW). The Guideline for Generic products covers all types of medicinal products and describe the procedures for a BE study. This “Fundamental Guideline” procedures are divided into two parts, dissolution testing and the in vivo BE study. Since publication of the previous chapter, the following changes have been made: A fed BE study has been required for solubility-enhanced IR and enteric coated formulations where, previously, a fasted study only was necessary. However, if the administration of the product requires it to be taken fasting, then a fed study is not required. If there is a significant difference in dissolution rate between the reference and test products, or if ethnic differences in gastrointestinal physiology including the level of gastric acidity are thought to affect the evaluation of BE due to formulation characteristics, a BE study in Japanese subjects is required. A further new requirement involves setting separate dissolution test conditions for solubility-enhanced IR formulations. For different strengths, the dissolution medium volume for the lower strength can be adjusted in the range 450–900 mL to achieve the same content per unit volume (the same dissolved concentration). A further change involves the statistical analysis relating to the adaption of additional data acquisition where the probability of a type 1 error is controlled instead of the previous method using the sum of data obtained in the pivotal study and an add-on subject study conducted separately from the pivotal study or a pilot study. It is noted that the recent ICH M13 guideline recommendations (“ICH Guidance: M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms, draft version, endorsed on December 20, 2022” [Online]. Available: https://www.fda.gov/media/165049/download . [Accessed 15 February 2024]) have not been considered for inclusion in the revised current Japanese BE study guideline issued in 2020.