From my translation from Russian:

The following safety information that may suggest changes in the benefit-risk ratio of the drug product is subject to expedited reporting to the regulatory bodies within 15 calendar days:

  1. imposition of restrictions on the drug product’s distribution; market withdrawal; non-renewal, revocation or suspension of marketing authorization in the territory of other countries for safety- or efficacy-related reasons;

  2. exceedance of the expected frequency of serious adverse reactions;

I feel that exceedance is stylistically wrong, it's a rare quaint word. What could be the alternative phrasing of this item in the list?

I thought of exceesive frequency but where to put the word expected, which is present in the Russian original?

So is there an alternative to the word "exceedance", a word or phrase with a noun function that has the same approximate meaning?

Maybe "violation of the upper limit of the expected frequency of serious adverse reactions?"

  • Does "overshooting" work? – AIQ Apr 16 '20 at 4:06

Maybe "exceeding the expected frequency of serious reactions."

But it still has a problem, as it doesn't specify a threshold to trigger the requirement. Maybe that's true of the original in Russian.

Maybe "frequency of serious reactions [exceeding/higher than] the expected level by []"

  • "frequency of serious reactions exceeding the expected level by []" - is spot-on, thank you! – CowperKettle Apr 16 '20 at 4:06

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