new drug product
- Guideline or reference source
- ICHQ6A Specifications: new chemical drug substances and products
- Definition
- A pharmaceutical product type, for example, tablet, capsule, solution, cream, etc., which has not previously been registered in a region or Member State, and which contains a drug ingredient generally, but not necessarily, in association with excipients.
- Related Term
- new drug substance
- new molecular entity
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