New stability - Yes or No - Similar product but for different intended use

[ortal]

Hi everyone,

I have a product that finished it's stability, biocompatability and registrationin the US and in EU.

Now, we want to register a similar product but for different intended use.
The differences between the products are that one of the ingredients was raised from 5% to 15% and another ingredient was decreased from 10% to 5%.

2 questions:
1. Do i need to perform new biocompatability tests?
2. Do i need to perform new stability?

Thanks!

 

[v9991]

it could help to have certain more details to respond more specifically,
to get started,
from drug product stand point, :- Answer for both would be '"YES".
this falls under SUPAC Level-1 changes; (EMEA ref)(depending upon the nature of those ingredients, it could even be level-2, but requires ) Depending upon specific product category/nature, require to apply relevant requirements.

from device stand point :- Answer would depend upon certain more details specific to the product. class of device, role/function of ingredient, etc Experts here could comment on specific reference for same. (I haven;t seen any specific reference to it)
but in general, i would like to think that the answer would be again an "YES" for both.
something to start with...@ European Medicines Agency - Post-authorisation procedural Q&A - Classification of changes: questions and answers