Sourcing · Regulatory · continued

Enforcement priorities versus written rules — does this still hold? posts 31–41

Sourcing › Regulatory EMA MHRA compounding FDA Solved Under review

This is a continuation of a long topic, addressed by post number rather than by page. Start at post 1 · go to the accepted answer.

r.mensahTL227 Aug 2025#31

f.amankwah, post #21: Picking up post #18: that is the part I would want checked first. Small correction to my own earlier position on Enforcement priorities. I had the units the wrong way round, which changes the conclusion by an order of magnitude and therefore changes it entirely. Go to post

Post #28 and I disagree about the size of the effect, not about the direction.

An honest declaration on Enforcement priorities: I have a prior here and it is strong enough that you should weight what I say downward. Stating it rather than hiding it.

0 likes in reply to #21 11mo

y.mensahTL3Wiki editor27 Aug 2025#32

Ridgeway, post #15: The documentation on Enforcement priorities is better than this thread and I say that as someone who has posted in the thread. Go to post

Taking post #31 at face value and following it one step further.

Import rules for personal quantities differ from commercial import rules and both differ by country. Establishing your own position is not something a forum can do for you.

The reasoning is more useful than the number, which is why I have shown it.

29 likes in reply to #15 11mo

v.rautioTL228 Aug 2025#33

Where I would push back on the Enforcement priorities consensus is the confidence, not the direction. The direction looks right. The confidence is borrowed.

9 likes 11mo

b.jankowiakTL3Regular28 Aug 2025#34

Small methodological point on Enforcement priorities: repeating a measurement is cheap and resolves most of what is being argued about here at no cost to anyone.

2 likes 11mo

s.vukovicTL229 Aug 2025 · edited#35

v.kjaer, post #20: Confirming post #17 from a second method, which matters more than confirming it from a second person. Import rules for personal quantities differ from commercial import rules and both differ by country. Establishing your own position is not something a forum can do for you. Worth one more sentence than it usually gets. Go to post

Where a claim about legality is made here, the useful follow-up is which instrument it rests on. Most such claims turn out to rest on a forum post.

0 likes in reply to #20 11mo

steady_stateTL3Regular29 Aug 2025#36

This follows post #35 rather than contradicting it.

I would keep Enforcement priorities and the decision it usually gets used for separate in this thread. They are related and they are not the same question, and merging them is why the last one went badly.

21 likes 11mo

c.castellanosTL230 Aug 2025#37

Coming back to post #35, because the follow-up matters more than the original answer.

Anything written here about regulatory status should be assumed stale after twelve months, which is why the documentation pages carry review dates.

That is what the documentation says. What happens in practice is usually close.

5 likes 11mo

n.ekstromTL2Regular31 Aug 2025#38

Generic or biosimilar entry depends on patent and exclusivity positions that are jurisdiction-specific and are frequently misreported.

Marking that as an opinion rather than a finding.

1 like 11mo

ar.kravchenkoTL231 Aug 2025#39

s.vukovic, post #35: Where a claim about legality is made here, the useful follow-up is which instrument it rests on. Most such claims turn out to rest on a forum post. Go to post

Two questions I would want answered before drawing anything from the Enforcement priorities data above: how were the cases selected, and what happened to the ones that dropped out.

30 likes in reply to #35 11mo

s.grahameTL2Member1 Sep 2025#40

Careful with the language on Enforcement priorities. "Not detected" and "not present" are different findings and the first is a statement about the method.

15 likes 11mo

j.hartmannTL21 Sep 2025#41

r.mensah, post #31: Post #28 and I disagree about the size of the effect, not about the direction. An honest declaration on Enforcement priorities: I have a prior here and it is strong enough that you should weight what I say downward. Stating it rather than hiding it. Go to post

If you can confirm or contradict a position for your own region, please date the answer. An undated regional claim is the least useful thing in this category.

I have no interest in any supplier named above.

0 likes in reply to #31 11mo

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