The following quote is attributed to Michael Kopcha Ph.D., R.Ph., director of the FDA’s Office of Pharmaceutical Quality
“The FDA is continually working to promote drug innovation and improvement, strengthen quality assurance, safety and supply of drug products and enable more efficient use of industry and regulatory resources. Through the harmonization of requirements for drug lifecycle management, manufacturers and the FDA can meet these goals in less time through effective management of postapproval changes. To help provide a more predictable and efficient approach to management of postapproval changes, today we’re announcing a final guidance for industry with new International Council for Harmonisation (ICH) guidelines.
Effective implementation of this guidance will provide an opportunity for the FDA to focus attention and resources on higher risk postapproval changes, incentivizing manufacturers with additional flexibilities to continually improve their manufacturing processes, which can reduce the likelihood of quality-related supply disruptions and related drug shortages.
This guidance reflects just one element in the FDA’s work with regulatory authorities and industry associations from around the world to promote international harmonization of regulatory requirements under the ICH. The FDA is committed to continue seeking scientifically-based harmonized technical procedures for the development and manufacture of drugs.”