Bioequivalence and Bioavailability Forum • New product

New product [Regulatives / Guidelines]

posted by Ohlbe – France, 2020-03-11 15:40 (1111 d 06:09 ago) – Posting: # 21249
Views: 3,975

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

Complete thread:

Immediate release fixed dose combination product ping4santosh 2020-03-06 09:21 [Regulatives / Guidelines]
- Immediate release fixed dose combination product Ohlbe 2020-03-06 10:35
  - Immediate release fixed dose combination product ping4santosh 2020-03-09 11:50
    - Immediate release fixed dose combination product ping4santosh 2020-03-11 12:22
      - Immediate release fixed dose combination product Ohlbe 2020-03-11 14:24
- Immediate release fixed dose combination product ElMaestro 2020-03-09 13:50
  - Immediate release fixed dose combination product Dr_Dan 2020-03-11 11:47
    - Immediate release fixed dose combination product ping4santosh 2020-03-11 12:21
      - Immediate release fixed dose combination product Dr_Dan 2020-03-11 13:44
        
        Immediate release fixed dose combination product ping4santosh 2020-03-11 14:22
        
        New productOhlbe 2020-03-11 14:40
        
        New product ping4santosh 2020-03-11 16:34
        
        New product Ohlbe 2020-03-11 17:54
        
        New product ping4santosh 2020-03-11 20:52
  - Immediate release fixed dose combination product ping4santosh 2020-03-11 12:18