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<p>The JPMA conducted a survey among its member companies regarding the use of Established Conditions (ECs) under ICH Q12. ECs can be set by companies that develop new drugs using the Quality by Design (QbD) approach defined in ICH Q8 and have an effective Pharmaceutical Quality System (PQS) as per ICH Q10. The survey revealed that while the use of QbD has increased, surpassing 70% in Japan since 2021, the adoption of ECs in New Drug Application (NDA) submissions remains low due to a lack of legal framework and internal understanding. More companies were using ECs in post-approval changes (PACs) compared to NDA submissions. The survey also found that companies prefer the existing systems in each region when determining the change category during change initiation. While Europe and the US believe that risk assessment of changes and ECs are consistent with an effective PQS, Japan perceives a mismatch between change assessment and predetermined change categories at the time of approval. This results in Japan willing to have an option applying the risk assessment at change control to reporting category evaluation. Considering these circumstances, it is anticipated that the use of ECs will gradually expand, primarily in PACs. The discrepancies in change procedures among countries may hinder a stable supply, so Japan should consider introducing change guidelines similar to those in Europe and the US to facilitate a hybrid approach to approvals that can accommodate the expanded use of ECs.</p>

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Implementation of Established Conditions and Use of Quality by Design Principles during Drug Development: Status in the US, EU, and Japan. Data from a Survey Conducted by the Japan Pharmaceutical Manufacturers Association (JPMA)

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  • 出版模式：

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  • 发表日期：

    2025年8月21日

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  • Yoshio Nakayama,
  • Sonoko Yamauchi,
  • Kozue Shimizume,
  • Akinobu Nakanishi,
  • Maki Masuyama,
  • Yasuyo Ozaki,
  • Koji Nakamura,
  • Makoto Fujikawa,
  • Masatsugu Kobayashi,
  • Yuji Kashitani

摘要

The JPMA conducted a survey among its member companies regarding the use of Established Conditions (ECs) under ICH Q12. ECs can be set by companies that develop new drugs using the Quality by Design (QbD) approach defined in ICH Q8 and have an effective Pharmaceutical Quality System (PQS) as per ICH Q10. The survey revealed that while the use of QbD has increased, surpassing 70% in Japan since 2021, the adoption of ECs in New Drug Application (NDA) submissions remains low due to a lack of legal framework and internal understanding. More companies were using ECs in post-approval changes (PACs) compared to NDA submissions. The survey also found that companies prefer the existing systems in each region when determining the change category during change initiation. While Europe and the US believe that risk assessment of changes and ECs are consistent with an effective PQS, Japan perceives a mismatch between change assessment and predetermined change categories at the time of approval. This results in Japan willing to have an option applying the risk assessment at change control to reporting category evaluation. Considering these circumstances, it is anticipated that the use of ECs will gradually expand, primarily in PACs. The discrepancies in change procedures among countries may hinder a stable supply, so Japan should consider introducing change guidelines similar to those in Europe and the US to facilitate a hybrid approach to approvals that can accommodate the expanded use of ECs.