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.
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.
For a drug to undergo technical evaluation for pediatric use, it must meet the following criteria: ① The active ingredient in its formulated version must be marketed in China, including both originator and generic drugs approved under GQCE standards, with a proven safety and efficacy profile, and its dosage form and specifications must be suitable for pediatric use. ② The same active ingredient in the same dosage form must be marketed internationally (in major ICH member countries) with approved pediatric indications, backed by substantial research evidence, and have clear pediatric dosage instructions in the drug labeling. ③ The drug must have a track record of widespread use in pediatric patients in China, with indications, usage, and dosage aligning with recommended treatment protocols in China’s clinical guidelines (or other widely recognized clinical documents). The clinical medication data must be verifiable, and the recommended pediatric treatment protocols in China’s clinical guidelines (or other widely recognized clinical documents) should be fundamentally consistent with the approved pediatric medication information in the labeling of overseas formulations with the same active ingredient and administration route.- Flcube.com
