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BIO Comments on ICH Q12 Draft Guideline

December 12, 2018

BIO submitted comments on the Food and Drug Administration (FDA) Draft Guideline, Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.

BIO appreciates FDA’s commitment to harmonization of regulatory concepts across regional Health Authorities through the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Harmonization of critical regulatory concepts is important to ensuring a consistent and predictable regulatory environment and gives sponsors confidence 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.

BIO is encouraged by the work of the ICH Q12 working group but has concerns about implementation. BIO provides general and specific comments to strengthen and clarify the guideline. The comments cover topics including regional variability in implementation, Established Conditions (ECs), Post-Approval Change Management Protocol (PACMP), Product Lifecycle Management (PLCM), and more.

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2018-12-15 BIO Comments On ICH Q12 FINAL
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