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In order to encourage the innovative research and development of children's medicines, optimize the communication and acceptance review efficiency of children's medicines, and improve the records and statistics of children's medicines, the remarks of children's medicines related to the declared varieties are now standardized.
When submitting clinical trial applications and marketing applications, the applicant should make a note under the "Other Matters" item in the drug registration application form (multiple notes can be noted): apply for children's specific drugs, apply for new children's applications (indications and usage and dosage) , This product belongs to the list of children's drugs that are encouraged to research and develop (indicate the batch and number)
When submitting a supplementary application, the applicant shall make a remark under the item of "Supplementary Application Content" in the drug registration application form (multiple notes can be noted): application for new children's application (indications and usage and dosage), application for revision of children's application (adaptation) Symptoms, usage and dosage), apply for the addition of special specifications for children, apply for revision of children’s application information in the manual, and apply for other matters related to children’s application
It will come into force on the date of the announcement
Hereby inform
Drug Evaluation Center of the State Drug Administration
July 9 2021