Once a biopharmaceutical product has been marketed, any chemistry, manufacturing and controls (CMC) changes must undergo regulatory review. The timelines for regulatory submissions vary per country, approval may take up to 24 months and the regulatory procedures can be complex and costly.
The ICH Q12 guideline was developed to provide a framework for the management of post-approval changes, enhance the transparency between the industry and the regulatory authorities and strengthen quality assurance and reliable supply of product.
This poster illustrates how the ICH Q12 guideline can be implemented to reduce unnecessary cost and time burdens on industry and regulators.
Download the poster to learn more.