Remarkably indeed, there were no real indications that a data-driven risk assessment allows escaping the systematic testing obligation, also no indications that feeding toxicological data in the risk assessment to escape CPCA cat. 1-2 could allow no systematic testing.
Of note, Swissmedic also said a few times that their interpret FDA is de facto aligned with their approach:
“We discussed our strategy with EMA and FDA to attempt to get harmonization on the obligation for CPCA cat. 1-2 NDSRI testing. The FDA re-evaluation request is not so different in our opinion though (although giving more time we feel the position of FDA is quite similar).”
- Q: FDA does not request systematic testing linked to cat. 1-2 CPCA independent of risk assessment?
- A: That is correct, but we think our approach is reasonable based on the in house testing and experience gained by Swissmedic and the conclusion that for a big % the risk was missed. In many cases we already asked companies to test where we tested, but this exercise is still going on. Just risk assessment alone is not enough for cat. 1-2 CPCA.
Swissmedic September 2023.pdf (5.0 MB)