I'm getting the impression the EMA got into the non-clinical data. How did the TGA get away with saying they didn't need to look at it, nor assess quality? From the TGA's pfizer AusPAR
"Quality : There was no requirement for a quality evaluation in a submission of this type."
"Nonclinical : There was no requirement for a nonclinical evaluation in a submission of this type"
Here is my old article
https://geoffpain.substack.com/p/production-of-the-pfizer-biontech
Quite horrific. Still going.
I'm getting the impression the EMA got into the non-clinical data. How did the TGA get away with saying they didn't need to look at it, nor assess quality? From the TGA's pfizer AusPAR
"Quality : There was no requirement for a quality evaluation in a submission of this type."
"Nonclinical : There was no requirement for a nonclinical evaluation in a submission of this type"
"Emergency"