The National Medical Products Administration (NMPA) has released the “Procedures for Adding Children’s Medication Information to the Package Inserts of Marketed Drugs,” which are effective immediately. The new procedures aim to enhance the information on children’s medication in the instructions of marketed drugs, ensuring safe medication practices for children.
Applicability and Eligibility
The document applies to eligible pediatric medical institutions, academics, and industry associations that request the addition of medication information for children in the drug instructions of listed chemical drugs and therapeutic biological products. It excludes cell gene therapy products and blood products from its scope.
Conditions for Adding Children’s Medication Information
The varieties intended to be added to children’s medication information must meet the following conditions:
- The active ingredient formulation has been marketed in China, including both the originator and/or a generic drug approved according to the quality and efficacy consistency evaluation (GQCE) standards of generic drugs, with clear safety and effectiveness, and the dosage form and specifications can meet the basic conditions for children’s use.
- The same active ingredient formulations with the same route of administration have been marketed overseas (major member countries of ICH) and have been approved for pediatric indications. There must be sufficient research evidence, and the dosage and usage for children are clearly stated in the drug instructions.
- In clinical practice in China, this variety has been widely used in pediatric patients, with indications, usage, and dosage basically consistent with the pediatric treatment plan recommended by the consensus in China’s clinical diagnosis and treatment guidelines. The clinical medication situation is clear, and clinical medication data is available. The recommended protocol for consensus in the guidelines should be basically consistent with the approved pediatric medication information in the drug instructions of overseas formulations with the same active ingredient (same route of administration).-Fineline Info & Tech
