Thursday, 28 May 2020

EMA publishes ICH guideline Q12

This guideline provides a framework to facilitate the management of post-approval CMC changes in a more predictable and efficient manner. A harmonised approach regarding technical and regulatory considerations for lifecycle management will benefit patients, industry, and regulatory authorities by promoting innovation and continual improvement in the pharmaceutical sector, strengthening quality assurance and improving supply of medicinal products.

The concepts outlined in prior ICH Quality Guidelines (ICH Q8(R2), Q9, Q10 and Q11) provide opportunities for science-and risk based approaches for use in drug development and regulatory decisions. These guidelines are valuable in the assessment of Chemistry, Manufacturing and Controls (CMC) changes across the product lifecycle. ICH Q8(R2) and Q11 guidelines focus mostly on early stage aspects of the product lifecycle (i.e., product development, registration and launch). This guideline addresses the commercial phase of the product lifecycle (as described in ICH Q10); and it both complements and adds to the flexible regulatory approaches to post-approval CMC changes described in ICH Q8(R2) and Q10 Annex 1.

For details, see:

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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