International – FDA issues ICH Q12 guidance and others on clinical trials, safety testing and biowaivers

The US Food and Drug Administration (FDA) on 11 May made available an International Council for Harmonisation’s (ICH) guideline on postapproval changes for drug products and issued four other final ICH documents and one draft guidance.
 
The ICH Q12 guideline aims to facilitate the management of postapproval chemistry, manufacturing and controls (CMC) changes for new and marketed pharmaceuticals and drug substances and is the same as the version endorsed by ICH as a step 4 document in November 2019.
 
“Effective implementation of this guidance will provide an opportunity for the FDA to focus attention and resources on higher risk postapproval changes, incentivizing manufactures with additional flexibilities to continually improve their manufacturing processes, which can reduce the likelihood of quality-related supply disruptions and related drug shortages,” Michael Kopcha, director of the Office of Pharmaceutical Quality said in a statement…