ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management

On 4 March 2020 the EMA published the Step 5 for 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.

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