Biocompatibility study conducted in the GLP lab outside Japan

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flyjly

#1
Hi all,

We are going to do the product registration in Japan.

Does anyone know if the biocompatibility studies such as cytoxicity, irritation or systemic study can only be done in Japan certificated GLP lab?

Or we can do all these test in the foreign countries outside Japan and MHLW/PMDA will accept it??

Any advice/comment will be much appreciated.

Eric
 
#3
Would you be able to check with the Japanese agency if they would accept those tests done outside Japan? I don't see why not to inquire & get feedback from the agency prior to arranging the tests. Just say, would you accept these test from X, Y & Z labs/sites?
:cfingers:Good luck!
 
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