Biocompatibility GLP conform tests outside China

Gamula

Involved In Discussions
#1
Dear Folks,

I hope that you are aware of biocompitibility GLP comform tests for registration at our beloved and compeltely predictable CFDA/ SFDA.

Flogging a Dead Horse :deadhorse: describes the work I have because I have numerous different contradictory infromation, thus, I am contacting the experts at the elsmar cove :)

All I know is the CFDA notice, which is two years old from 2015 (No. 247). It says: "Yes, you can do biocompatibility tests outside of China as long as the study report is in line with GLP!"

Nevertheless, I was informed by our agent that this is not completely applicable. We had to conduct one biocompitibility test "Intracutaneous reaction test" at the test center in China.

Additiionally, we were told in a very speculative way that it is tough receiving the respective reports from the testing institute. If we were lucky we could receive a paper version in Chinese.

After some discussions with two GLP certified testing laboratories we were told that it is not needed to do tests in China as long as the GLP certificate certificates the laboratory as applicable for certain / biocompitibility tests. They have sucessfull created study reports according to GLP, which were accepted.

But, the CFDA told our agent to be aware that they did not approve a GLP conform study report outside form China.

What is the actual situation? Does anyone know any information on this weird and tricky situation?

Maybe, I need a magician :magic:

I would appreciate to read posts solving or struggeling with the same issue or shall we just start Flogging a Dead Horse :deadhorse: ??
 
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