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Jordan Joins PICS Pharmaceutical Inspection Scheme · DDReg Knowledge Capsule

• 0:00
  Speaker 1: Welcome to Deeter reg knowledge capsule. So imagine you're a
• 0:03
  Speaker 1: pharma company, right, and you're trying to sell some life
• 0:06
  Speaker 1: saving medicine in I don't know, twenty different countries, yeah.
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  Speaker 2: Which is usually a total logistical nightmare.
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  Speaker 1: Exactly a complete nightmare, because historically that meant twenty different
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  Speaker 1: sets of international regulators flying out to inspect your factory,
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  Speaker 1: asking for twenty slightly different variations of the exact.
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  Speaker 2: Same paperwork, right, and that redundancy costs millions of dollars,
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  Speaker 2: not to mention, causing these massive supply chain bottlenecks. Right.
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  Speaker 1: So today's deep dive explores a huge strategic shift designed
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  Speaker 1: to solve that exact problem. Because on January first, twenty
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  Speaker 1: twenty six, the Jordan Food and Drug Administration, the JFDA,
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  Speaker 1: officially join PICS. That's the Pharmaceutical Inspection Cooperation Scheme.
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  Speaker 2: It is a massive deal. Jordan is now the fifty
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  Speaker 2: seventh participating authority globally, and notably, they are only the
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  Speaker 2: second Arab nation to gain full membership.
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  Speaker 1: Wow. Really just the second, yeah.
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  Speaker 2: Just the second. The final approval came through at this
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  Speaker 2: November twenty twenty five meeting in Hong Kong, where Kathleen
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  Speaker 2: Senager of the USFDA also took over as the organization's chair.
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  Speaker 1: Okay, let's unpack this a bit, because joining PICS it
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  Speaker 1: feels a lot like earning this highly coveted, globally recognized
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  Speaker 1: like verified blue check mark for pharmaceutical manufacturing.
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  Speaker 2: That is actually a great analogy.
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  Speaker 1: Right, But besides the obvious regional bragging rights, we need
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  Speaker 1: to look at what this regulatory alignment actually changes on
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  Speaker 1: the factory floor, like in a man for example, what
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  Speaker 1: actually changes.
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  Speaker 2: Well, the core purpose here is getting global regulators to
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  Speaker 2: execute the exact same good Manufacturing Practice or GMP playbook.
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  Speaker 2: I mean it fundamentally overhauls how oversight functions.
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  Speaker 1: Okay, so less about just ticking boxes exactly.
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  Speaker 2: Instead of a culture where inspectors just you verify that
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  Speaker 2: standard operating procedures are written down in a binder somewhere,
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  Speaker 2: PICS demands evidence based risk managed quality systems.
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  Speaker 1: So instead of a factory just showing an inspector and
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  Speaker 1: manual that says, hey, look we clean our machines, the
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  Speaker 1: facility has to actively prove their systems are engineered to
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  Speaker 1: catch contamination.
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  Speaker 2: Right before a single pill is even compromised. That is
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  Speaker 2: a massive shift from reactive checking to proactive monitoring, which.
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  Speaker 1: Brings up a really critical question. I think for anyone
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  Speaker 1: looking at global supply chain logistics. If Jordan now holds
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  Speaker 1: this global blue check mark, does that mean a factory
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  Speaker 1: there can just automatically ship and sell its products in
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  Speaker 1: the US or Europe tomorrow. I mean it sounds like
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  Speaker 1: an all access pass.
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  Speaker 2: It is so tempting to view it that way, but no,
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  Speaker 2: PICS membership absolutely does not grant automatic market access. You
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  Speaker 2: just cannot bypass individual country registrations. Oh interesting, Yeah, regulators
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  Speaker 2: in the US or Europe they're still going to require
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  Speaker 2: full dossier reviews, meaning they will still scrutinize the mountain
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  Speaker 2: of clinical and technical data specific to a particular drug
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  Speaker 2: before it can legally be sold in their borders.
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  Speaker 1: I get it. The check mark proves the industrial kitchen
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  Speaker 1: is clean, but you still have to to get your
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  Speaker 1: specific recipe approved by the local food critic.
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  Speaker 2: Yes, perfect way to phrase it. What this membership actually
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  Speaker 2: accomplishes is broadcasting a massive signal of assurance. You know,
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  Speaker 2: multinational pharma companies are constantly looking for contract manufacturing organizations
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  Speaker 2: to outsource their production.
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  Speaker 1: Too, and I imagine a PICS A line facility jumps
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  Speaker 1: straight to the top of that list.
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  Speaker 2: Exactly. They jump to the top of a very short,
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  Speaker 2: highly trusted list of global partners because buyers know the
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  Speaker 2: oversight there meets strict international standards.
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  Speaker 1: But getting on that trusted list is one thing, and
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  Speaker 1: staying on it is another. For investors or supply chain managers.
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  Speaker 1: What do these companies in Jordan actually have to do
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  Speaker 1: to keep up because the new hurdles seem to basically
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  Speaker 1: remove human hope from the equation totally.
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  Speaker 2: Looking at the framework, there are six critical compliance areas
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  Speaker 2: they have to nail. First, upgrading their pharmaceutical quality systems
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  Speaker 2: and implementing really strict quality risk.
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  Speaker 1: Management okay, systems and risk management. What else?
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  Speaker 2: They have to ensure bulletproof data integrity, rigorously validate all
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  Speaker 2: their equipment, fix root causes through CAPIA which is corrective
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  Speaker 2: and preventive action, and heavily audit their raw material suppliers.
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  Speaker 1: That is intense. Taking just the equipment validation part, I
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  Speaker 1: mean a facility can no longer just buy a brand
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  Speaker 1: new expensive machine, read the spec sheet and assume it
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  Speaker 1: produces perfect medicine.
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  Speaker 2: Not at all, it's the difference between buying a high
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  Speaker 2: end oven and actually baking a test cake in it
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  Speaker 2: fifty times to prove it never burns the edges, you
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  Speaker 2: have to prove this sustained physical outcome, not just trust
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  Speaker 2: the equipment tag.
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  Speaker 1: Right, which feeds directly into the capia protocol you mentioned.
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  Speaker 1: If a pipe is leaking, you don't just slap a
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  Speaker 1: bandiate on it.
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  Speaker 2: An auditor expects you to tear down the wall, find
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  Speaker 2: the root cause, fix the plumbing at the source, and
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  Speaker 2: update the facility protocol so no pipe ever leaks the
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  Speaker 2: same way again.
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  Speaker 1: Wow, So what does this all mean for you listening? Basically,
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  Speaker 1: if you are tracking the Mana Regions pharmaceutical landscape, this
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  Speaker 1: deep dive highlights why Jordan just significantly leveled up its credibility.
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  Speaker 2: Yeah. By elevating their practices from reactive paperwork to proactive
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  Speaker 2: bulletproof systems, they're cementing themselves as a highly reliable manufacturing help.
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  Speaker 1: But it does make you wonder about the ripple effects right. Oh?
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  Speaker 2: Absolutely, And that's really the final thought I'd leave you with.
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  Speaker 2: As global supply chains grow more complex and countries like
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  Speaker 2: Jordan drastically raise their standards to meet these PICS expectations.
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  Speaker 2: Is this going to create a domino.
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  Speaker 1: Effect like forcing neighboring non member nations to overhaul their own.
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  Speaker 2: Regulations exactly just to stay competitive, Because in a global
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  Speaker 2: pharma market that increasingly prioritizes standardized trust, operating without that
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  Speaker 2: level of alignment might eventually just cost you your seat
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  Speaker 2: at the table.