ICH Q12: Implementation Considerations for FDA-Regulated Products

On 19 May 2021 the FDA published this draft guidance on the International Council for Harmonization (ICH) Q12 for industry.

The ICH guidance for industry Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management and its Annexes (ICH Q12, May 2021) provides a framework to facilitate the management of postapproval chemistry, manufacturing, and controls (CMC) changes in a more predictable and efficient manner. ICH Q12 includes regulatory tools and enablers with associated guiding principles that should enhance industry’s ability to manage postapproval changes and increase transparency between industry and regulatory authorities, supporting innovation and continual improvement.

This guidance should be read in conjunction with ICH Q12, which this guidance complements by clarifying how the ICH Q12 tools and enablers can be implemented within the U.S. regulatory system. These guidances apply to drug substances and drug products that are the subject of new drug applications (NDAs), biologics license applications (BLAs), abbreviated new drug applications (ANDAs), and supplements to these applications regulated by the Center for Drug 30 Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).

They also apply to combination products with device constituent parts that are the subject of NDAs, BLAs, ANDAs, and supplements to these applications regulated by CDER and CBER.

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