JAPAN APPROVALS DATABASE (JAD)
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Regulatory Class assigned when the Marketing Approval is granted


Class

Definition
1 Medicines with new active ingredients
2 New combination medicines excluding medicines Class 7-2 and trivial combinations
3 Medicines with new route of administration
4 Medicines with new indications
5 Medicines with new dosage forms
6 Medicines with new doses
7 Medicines with additional dosage forms: excluding the medicines Class 5
7-2 Medicines with similar formulations
8 Miscellaneous



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