New product [Regulatives / Guidelines]

posted by Ohlbe – France, 2020-03-11 14:40  – Posting: # 21249
Views: 1,981

Dear SKM,

» Both the APIs are registered as individual products in market and we are just combining both. Why would you call it as a new product [...]

Because that's what it is. You have to distinguish API and formulation. This will be a new combination of two existing API.

By the way, if I'm not mistaken it would also be considered a "new drug" in India, according to the New Drugs and Clinical Trials Rules, 2019, Chapter 1, § 2 (1) (w) (iii): a fixed dose combination of two or more drugs, approved separately for certain claims and proposed to be combined for the first time in a fixed ratio, or where the ratio of ingredients in an approved combination is proposed to be changed with certain claims including indication, route of administration, dosage and dosage form.

Regards
Ohlbe

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