Draft Guidance – Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled “Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.” The guidance, which was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), provides a framework to facilitate the management of post-approval chemistry, manufacturing, and controls (CMC) changes for new and marketed pharmaceutical drug substances and drug products. 

The guidance facilitates innovations in manufacturing by taking a flexible, risk-based approach to regulatory oversight and a more predictable and efficient approach to management of post-approval CMC changes. It is also intended to demonstrate how increased product and process knowledge can contribute to a reduction in the number of regulatory submissions.  These steps will help reduce unnecessary costs and burden for both manufacturers and regulators.

In addition to benefitting industry and regulators, the guidance will continue to assure that patients have access to high quality therapies.  The guidance encourages continual product improvement, which may help reduce product variability, and may mitigate shortages related to manufacturing and quality issues.  The framework in the guidance may also help support the development of breakthrough drugs while ensuring product quality.

FDA publishes ICH guidelines as FDA guidances. This guidance reflects just one element in FDA’s work with regulatory authorities and industry associations from around the world to promote international harmonization of regulatory requirements under the ICH. One of the goals of harmonization is to identify and reduce differences in technical requirements for drug development among regulatory agencies. FDA is committed to seeking scientifically based harmonized technical procedures for the development and manufacture of pharmaceuticals.