I would to ask a question. In my Plant we would manufacture a product via fermentation. The steps of process are: fermentation step, the first and purification step, the second one. The final product contain an API recognized from Authority (FDA and EMA), but this process of manufacturing will be different from that one validated. Moreover the product will be used for toxicological tests.
At what point we are as regarding on point of regulation view? I would like to know…what is this product? (pre- IND?; IMP?; one process one product?)
What is the regulations that I must follow?
We need authorization (FDA and EMA) in this phase or not?
Please may anyone resolve this question because I don’t have a clear idea
thanks in advance
This looks clearly like Investigational Medical Product. (IMP).
Here is the EU guidance.
You can get most of details here.
Thank you very much, Durga, for the answers you always give immeditely. However I want to transcribe what I read on " VOLUME 10 - GUIDANCE… TO CLINICAL TRIALS …(IMPS) AND …(NIMPS) (REV. 1, MARCH 2011) from your link.
Directive 2001/20/EC defines in Article 2 (d) an IMP as “a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial,including products already with a marketing authorization but used or assembled (formulated or packaged) in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form.”
I would like to focus attention on term “pharmaceutical form” …. but the product we will manufacture, is an API and not pharmaceutical form, so I think that it isn’t a IMP, don’t you agree?
So, I can read again and try if it looks a NIMPs.
Howerver I want to ask you, do you think that for this “product” it is necessary to have a particular or specific manufacturing authorization?