China’s Center for Drug Evaluation (CDE) has issued a notice outlining the “Detailed Rules for Adding Pediatric Medication Information to the Labeling of Listed Drugs.” The notice provides clarity on the procedural steps for updating pediatric labeling information on drugs.<\/p>\n\n\n\n
Under the new guidelines, originator companies are permitted to directly submit supplementary applications to amend drug instructions to include pediatric medication data. Generic drug manufacturers, prior to submitting their applications, must ensure that their products are either approved as generics to the same standards as the reference formulation or have passed the generic quality consistency evaluation (GQCE). Marketing Authorization Holders (MAHs) can propose revisions to drug instructions concurrent with their GQCE application, referencing published information to add pediatric content.<\/p>\n\n\n\n