Are you ready for a little regulatory rollercoaster. So, here’s the scoop – a CEO from a pharmaceutical company just knocked on my door (figuratively, of course) with a regulatory head-scratcher that’s too good not to share.
Picture this: they’ve got this licensed product, a golden goose of sorts, but there’s a little snag. The license insists on tamper-evident, but the manufacturer for the upcoming batch can’t lay hands on the magical tamper-evident material. Cue the dramatic gasp.
Now, here’s the plot twist – the regulatory authority once suggested turning this medicinal product into a medical device. The regulatory authority wanted to wait until the medical device regulations were as clear as a London fog, and member states’ dance was sorted in terms of medical device regulations.
Now, the CEO is caught in a bit of a conundrum. To submit the BSV (Batch Specific Variation) or not? It sounds like a simple yes or no, right? Well, hold your horses, because the CEO dropped the bomb that the commercial value of this batch is significant. Money talks, my friend.
I threw the million-dollar question at him: What if the regulatory authority decides to throw a curveball and tells you to convert this product into a medical device? His response? They don’t have the infrastructure to handle the medical device gig, so for now, it’s a hard pass.
Oh, and when will they get their hands on that elusive tamper-evident supply? March 2024. Yeah, it’s a bit like waiting for the next season of your favourite show.
My response was a classic case of risk assessment. The risk of a BSV is low since the product is a solid ‘P’ and tamper-evident isn’t mandatory. But (and there’s always a but), they need to tell the world about the tamper-evident hiccup.
Now, here’s the kicker – if the regulatory authority decides to make this a medical device marathon, you’re looking at a product shortage in the long run. So, do you risk one batch or jeopardize the long-term supply? Tough call.
The CEO took this nugget of wisdom back to the team for a pow-wow. It’s not just about making a decision; it’s about doing a tightrope walk of risk assessment to figure out what you can juggle and what you need to dodge.
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Best regards,
Aziz