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BIO Comments on International Council for Harmonisation Q12: Implementation Considerations for FDA-Regulated Products

July 21, 2021

BIO appreciates FDA’s commitment to harmonization of regulatory concepts across regional Health Authorities through the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). Harmonization of critical regulatory concepts is an important part of ensuring a consistent and predictable regulatory environment and gives sponsors confidence that their drug development program will be generally accepted within different regions. BIO believes that the concepts in Q12 are important and warrant broad recognition across the globe. Even though implementation of Q12 is voluntary, this Draft Guidance explains FDA’s expectations on implementation of Q12 (e.g., format, eCTD locations for information) if an applicant so chooses to implement Q12 and thus is a helpful document.

In BIO's comments, we requested additional clarity on how the Q12 draft guidance should be utilized by industry in conjunction with previously issued FDA guidances. We also noted the importance of globally aligned requirements for Established Conditions (ECs) and urged the Agency to carefully consider the terminology used throughout the draft guidance. Furthermore, we expressed concern about the potential introduction of new terms which are not internationally aligned. In line with this overarching feedback, a number of specific redline edits were provided.

Download Full Comments Below
BIO Comment Letter on ICH Q12: Implementation Considerations for FDA-Regulated Products
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