Echoing draft guidance posted by the US Food and Drug Administration (FDA) earlier this year, CFDA is proposing to class postapproval changes as “major,” “moderate” or “minor.” The classification of the change is determined by its possible impact on drug safety, efficacy and quality and dictates the level of regulatory scrutiny it will face. CFDA, like its counterpart in the US, wants companies to receive its blessing before making major changes. This precaution reflects the risk such changes will alter the attributes of the drug. The agency is proposing a more relaxed approach to moderate and minor changes. To make a moderate change, a company must make a submission to CFDA. Unless CFDA denies or challenges the change within a certain amount of time, the applicant can go ahead and make the revision. Companies can make minor changes without first contacting CFDA. In some circumstances, CFDA expects manufacturers to submit three batches made after the change for testing by one of its regional outposts. When moving to a new production site, CFDA expects manufacturers to use Quality-by-Design principles to understand their products and manage the relocation. This entails considering the possible effects of moving to a new site on critical quality attributes. CFDA set out its thinking on the subjects in three documents. The agency is accepting feedback on the drafts until 13 November. More Information On RAPS