The Center for Drug Evaluation (CDE) has released the “Work Procedures for Adding Children’s Drug Information to the Listed Drugs’ Package Insert (Trial),” which is effective immediately. This document is designed to provide a framework for qualified pediatric-related medical institutions, societies, and industry associations to propose the inclusion of children’s medication information in the medication package inserts of listed chemical drugs and therapeutic biological products, excluding cell gene therapy products and blood products.
Eligibility and Requirements for Pediatric Medication Information Addition
The document outlines that entities wishing to add children’s medication information to marketed medication package inserts must submit written suggestions to the CDE. The drugs intended for the addition of pediatric information should meet the following criteria:
- The active ingredient formulation has been listed in China, including both originators and generic drugs approved according to the quality and efficacy consistency evaluation standards, with clear safety and effectiveness, and the dosage form and specifications can meet the basic conditions for children’s use.
- Preparations of the same active ingredient with the same route of administration have been marketed overseas (major member countries of ICH) and have been approved for children’s indications, with sufficient research evidence, and the use and dosage of children in the medication package insert are clear.
- In clinical practice in China, this variety has been widely used in pediatric patients, with indications, usage, and dosage basically consistent with the recommended pediatric treatment plan in China’s clinical diagnosis and treatment guidelines (or other widely recognized and accepted clinical documents). The clinical medication situation is clear, and clinical medication data can be checked. The treatment plan for children recommended in China’s clinical diagnosis and treatment guidelines (or other documents with broad consensus and acceptance in clinical practice) is basically consistent with the drug information for children approved in the medication package insert of overseas preparations with the same active ingredient (the same route of administration).-Fineline Info & Tech
