New product [Regulatives / Guidelines]

posted by Ohlbe – France, 2020-03-11 13:40 (362 d 02:34 ago) – Posting: # 21249
Views: 3,294

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.


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