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RegisterEU Transdermal Patch: Generic Submission [Design Issues]
Hi All
One of the clients with whom I am working is developing a generic transdermal patch for UK/EU submission.
They are asking us to do the PK study, Adhesion study and skin senstization study in either EU/UK or in USA due to simialr climatic condition.
My question is, can these studies be done in India or any other countries? Does MHRA/EMA accepts transdermal studies done in the geographies which has a different climatic conditions?
TIA...
Edit: Category changed; see also this post #1. Are you really located in Japan?
[Helmut]
Shhhhh
One of the clients with whom I am working is developing a generic transdermal patch for UK/EU submission.
They are asking us to do the PK study, Adhesion study and skin senstization study in either EU/UK or in USA due to simialr climatic condition.
My question is, can these studies be done in India or any other countries? Does MHRA/EMA accepts transdermal studies done in the geographies which has a different climatic conditions?
TIA...
Edit: Category changed; see also this post #1. Are you really located in Japan?
[Helmut] ShhhhhComplete thread:
- EU Transdermal Patch: Generic SubmissionHallaGulla 2023-03-08 08:58 [Design Issues]
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Ing. Helmut Schütz