On May 31, 2023, China National Medical Products Administration (NMPA) released the Work Procedures for Adding Pediatric Information to Medication Package Inserts of Authorized Drugs (Trial) with immediate effect.
Applicable Scope
The regulation only allows qualified pediatric-related medical institutions, academic societies, and industry associations to propose the addition of the pediatric medication information.
Product Qualification
Not all drugs’ medication package inserts are permitted to contain pediatric medication information. Eligibility entails all the following conditions:
1) The product should be a chemical drug or a biological product (except cell & gene therapy and blood products) that has received marketing authorization in China.
2) The product with its active ingredient should have marketing authorization in China. The product can be an original drug or a generic drug that have passed the quality and therapeutic equivalence evaluation. The product should be proved to be safe and effective based on clear data. Its dosage form and strength should meet the basic conditions for pediatric use.
3) The proposed product should have a counterpart with the same active ingredient and the same route of administration. The counterpart should be authorized overseas (in major ICH members), and approved for the pediatric indication supported by fairly sufficient research, whose usage and dosage for pediatric patients are specified in the medication package inserts.
4) In the clinical practice, the drug has been widely used in pediatric patients in China. The proposed product’s indication, usage, and dosage are basically consistent with those in China’s clinical diagnosis & treatment guidance (or other documents widely recognized in clinical practice). The drug should have clear clinical medication history and traceable clinical medication data. The therapeutic protocol for children recommended by China's clinical diagnosis & treatment guidance (or other documents widely recognized in clinical practice) is basically aligned with the pediatric medication information of foreign drugs with the same active ingredient and the same route of administration.
Procedure
NMPA outlines the procedures for the addition of pediatric medication information to authorized products. NMPA’s Center for Drug Evaluation (CDE) will issue the specific procedures in the future.
Phase 1: Qualified medical institutions, academic societies, or industry associations submit a written proposal to CDE.
Phase 2: CDE conducts technical review and calls on a panel to evaluate the proposed information.
Phase 3: CDE publicizes the list of drugs proposed for medication package insert revision. If there is no objection during the publicity period, the listed drugs will finally be announced by NMPA for granted revision. If there is objection, the challenged drug will enter the reevaluation process, which will include panel investigation & evaluation when necessary.
Phase 4: After NMPA releases the revision advice, the marketing authorization holder (MAH) can submit the supplemental application for adding the pediatric information, which should comply with NMPA’s advice.
Legal Basis
CDE will review the application according to the regulations:
- ICH E11 (R1) Guideline on Clinical Investigation of Medicinal Products in the Pediatric Population;
- Technical Guidelines on Drug Clinical Trials in Pediatric Population;
- Technical Guidelines on Extrapolation of Adult Medication Data to Pediatric Population.
- etc.
Ask BaiPharm if you’d like to know more about post-marketing changes to authorized drugs.
