Latest / DDReg Knowledge Capsule / Indonesia's Pharma Market: BPOM Drug Registration Decoded

Transcript

Indonesia's Pharma Market: BPOM Drug Registration Decoded · DDReg Knowledge Capsule

• 0:00
  Speaker 1: Welcome to the dedrig knowledge capsule. Imagine spending two billion
• 0:05
  Speaker 1: dollars in like ten years developing a life saving.
• 0:07
  Speaker 2: Drug, right, a massive investment exactly.
• 0:10
  Speaker 1: You successfully navigate the clinical trials, you get approvals from
• 0:13
  Speaker 1: the FDA in the US, the EMA in Europe, and
• 0:16
  Speaker 1: you're prepping to launch into this massive new international market,
• 0:21
  Speaker 1: and then you have the entire submission completely rejected, banned
• 0:25
  Speaker 1: from entry because of like a misplaced underscore in a
• 0:29
  Speaker 1: PDF file.
• 0:29
  Speaker 2: Name. Yeah, I mean it sounds totally absurd, but in
• 0:32
  Speaker 2: the realm of global pharma regulation, that level of granular,
• 0:37
  Speaker 2: unforgiving scrutiny, that's just a daily reality.
• 0:39
  Speaker 1: It's wild. You just can't take a standardized corporate blueprint
• 0:42
  Speaker 1: and copy paste it onto a new map.
• 0:44
  Speaker 2: No, absolutely not. That assumption just does not apply here.
• 0:47
  Speaker 1: Right, So today our mission on this deep dies is
• 0:49
  Speaker 1: cracking the code of Southeast Asia's largest pharmaceutical market. We're
• 0:53
  Speaker 1: talking about Indonesia, and the stakes for you listening right
• 0:56
  Speaker 1: now are astronomical huge.
• 0:58
  Speaker 2: I mean, it's a population of over two hundred and
• 1:00
  Speaker 2: seventy million people, over.
• 1:02
  Speaker 1: Two hundred and seventy million plus. There's this rapidly expanding
• 1:06
  Speaker 1: middle class, massive government investment in universal health coverage, and
• 1:12
  Speaker 1: just an unprecedented demand for innovative healthcare.
• 1:15
  Speaker 2: Yeah, it is undeniably one of the most lucrative opportunities
• 1:18
  Speaker 2: on the planet.
• 1:19
  Speaker 1: And this is a big but standing squarely at the
• 1:21
  Speaker 1: gate is Indonesia's National Agency of Drug and Food Control BPOM.
• 1:26
  Speaker 2: Right, BPOM, and they enforce a regulatory landscape that operates
• 1:31
  Speaker 2: with its own completely distinct procedural logic. It's got unique
• 1:35
  Speaker 2: language requirements and well an incredibly strict interpretive framework.
• 1:40
  Speaker 1: And I think it's so easy to look at that
• 1:41
  Speaker 1: strictness and just dismiss it right, like, oh, it's just
• 1:44
  Speaker 1: bureaucratic red tape. But why does BPOM actually operate with
• 1:47
  Speaker 1: this iron fisted approach.
• 1:49
  Speaker 2: Well, it comes down to what they're tesked with protecting.
• 1:51
  Speaker 2: BPOM isn't just creating paperwork to be difficult. I mean
• 1:54
  Speaker 2: they are guarding a massive, highly vulnerable population that's spread
• 1:57
  Speaker 2: across thousands of islands.
• 1:59
  Speaker 1: Islands, multiple time zones, different climates.
• 2:02
  Speaker 2: Exactly. They have to ensure that a drug works just
• 2:04
  Speaker 2: as safely in say a high tech hospital in central
• 2:08
  Speaker 2: Jakarta as it does in a totally remote rural clinic
• 2:11
  Speaker 2: in Sumatra.
• 2:12
  Speaker 1: Wow. Yeah, that's a huge logistical gap.
• 2:15
  Speaker 2: Right. So I always caution people against this really common
• 2:18
  Speaker 2: assumption thinking that an FDA or European approval is some
• 2:22
  Speaker 2: sort of golden.
• 2:22
  Speaker 1: Ticket like a VIP pass.
• 2:24
  Speaker 2: Exactly, BPOM doesn't care about your VIP status in other countries.
• 2:28
  Speaker 2: You have to prove yourself entirely on their terms.
• 2:31
  Speaker 1: Okay, So let's figure out how to actually do that,
• 2:33
  Speaker 1: starting with the very first hurdle, because before a company
• 2:36
  Speaker 1: even compiles a single page of clinical data, there's a
• 2:40
  Speaker 1: fundamental legal firewall they have to breach.
• 2:42
  Speaker 2: The local anchor, Yes, who.
• 2:44
  Speaker 1: Is actually allowed to own the drugs registration in Indonesia this.
• 2:48
  Speaker 2: Is the foundation of everything. So under Indonesia's government regulation
• 2:52
  Speaker 2: number five of twenty twenty one, this is on risk
• 2:54
  Speaker 2: based business licensing. To legally sell a drug, you need
• 2:57
  Speaker 2: a marketing authorization.
• 2:59
  Speaker 1: Which locally is now is the NIE right right?
• 3:01
  Speaker 2: The NIE or no more eiesen Edar. And the absolute
• 3:04
  Speaker 2: deal breaker here is that a foreign manufacturer cannot hold
• 3:07
  Speaker 2: an NIE.
• 3:08
  Speaker 1: In their own name, right really?
• 3:10
  Speaker 2: Yeah, you cannot simply operate this out of a global
• 3:13
  Speaker 2: headquarters in like Switzerland or New Jersey.
• 3:17
  Speaker 1: So the NIE must be held by an Indonesian legal entity.
• 3:20
  Speaker 1: You need a local legal anchor basically someone with boots
• 3:24
  Speaker 1: on the ground in the country whose name is physically
• 3:27
  Speaker 1: on the dotted line.
• 3:28
  Speaker 2: Correct, And not just any local entity either. It has
• 3:31
  Speaker 2: to be an organization that holds a valid BPOM issued
• 3:36
  Speaker 2: pharmaceutical import license.
• 3:38
  Speaker 1: Ah. So you can't just use a shell company.
• 3:40
  Speaker 2: Definitely not. You have to establish a subsidiary or partner
• 3:43
  Speaker 2: with a qualified local registration holder before you even think
• 3:47
  Speaker 2: about initiating a submission.
• 3:48
  Speaker 1: Okay, but let me play Devil's advocate here. If I'm
• 3:51
  Speaker 1: a global pharma CEO, why can't I just hand this
• 3:53
  Speaker 1: off to my local delivery distributor. May they already have
• 3:56
  Speaker 1: the refrigerated trucks, they own the warehouses, they know the
• 3:59
  Speaker 1: local delivery. That's sure, they have the logistics, right, So
• 4:01
  Speaker 1: why wouldn't I just pay them to hold the NIE
• 4:04
  Speaker 1: and call it a day.
• 4:05
  Speaker 2: Because that is precisely how multimillion dollar supply chains collapse. Oh, seriously,
• 4:11
  Speaker 2: you cannot confuse logistical distribution reach with regulatory competence. The
• 4:16
  Speaker 2: local registration holder isn't just acting as a mailbox to
• 4:20
  Speaker 2: forward BPOMS letters to your headquarters.
• 4:22
  Speaker 1: They're actually on the hook.
• 4:23
  Speaker 2: They bear the ultimate legal liability for that product in Indonesia.
• 4:28
  Speaker 1: Meaning they're legally responsible if something goes wrong.
• 4:31
  Speaker 2: Exactly, they're accountable for the product's ongoing quality and for
• 4:35
  Speaker 2: a highly critical process called pharmacovigilance.
• 4:38
  Speaker 1: And for those unfamiliar, pharmacovigilance is basically the continuous, rigorous
• 4:43
  Speaker 1: scientific monitoring of a drug safety once it hits the public,
• 4:47
  Speaker 1: right tracking adverse reaction, side effects, long term data.
• 4:51
  Speaker 2: You got it. So a logistics distributor might be fantastic
• 4:55
  Speaker 2: at moving palettes from point A to point B. But
• 4:58
  Speaker 2: if BPM suddenly demands a highly technical periodic safety update report,
• 5:03
  Speaker 2: or say you need to file a complex variation application
• 5:06
  Speaker 2: because you changed an ingredient supplier in Germany, that distributor
• 5:10
  Speaker 2: is going to completely freeze.
• 5:11
  Speaker 1: Because they don't have the scientific personnel exactly.
• 5:14
  Speaker 2: They lack the scientific chops and when they fail to comply,
• 5:17
  Speaker 2: EPOM pulls your drug from the market.
• 5:20
  Speaker 1: Wow. So relying on a delivery guide to do a
• 5:22
  Speaker 1: scientist's job will literally get you evicted from.
• 5:26
  Speaker 2: The market one hundred percent. You need a dedicated, highly
• 5:28
  Speaker 2: competent regulatory affairs partner.
• 5:31
  Speaker 1: Okay, So once you have that local anchor secured to
• 5:34
  Speaker 1: take on the liability, how do you actually package your
• 5:36
  Speaker 1: science to meet Indonesian standards.
• 5:39
  Speaker 2: Well, you have to determine your registration pathway first. BPOM
• 5:43
  Speaker 2: generally divides these into three lanes free lanes, got it.
• 5:46
  Speaker 2: The first is for new drugs, so innovative medicines, new
• 5:49
  Speaker 2: chemical entities, biologicals. This requires a massive, comprehensive dossier submitted
• 5:55
  Speaker 2: in what's called the ACTD format.
• 5:56
  Speaker 1: The ACTD that stands for the as in Common Technical Dossier.
• 6:00
  Speaker 2: Yes, it's a standardized structure used across Southeast Asian nations
• 6:04
  Speaker 2: to organize quality non clinical and clinical data.
• 6:07
  Speaker 1: So there is at least an attempt at regional standardization.
• 6:10
  Speaker 1: That's good. What about the other lanes?
• 6:12
  Speaker 2: The second pathway is for generic drugs. The critical requirement
• 6:16
  Speaker 2: here is proving bioequivalents.
• 6:18
  Speaker 1: Meaning you have to scientifically demonstrate that your generic version
• 6:22
  Speaker 1: acts in the human bloodstream identically to the original brand
• 6:26
  Speaker 1: name drug exactly.
• 6:27
  Speaker 2: But here's the catch. BPOM doesn't just trust any lab data.
• 6:32
  Speaker 2: Those bioequivalent studies must be conducted at facilities that BPMN
• 6:36
  Speaker 2: itself has it credited.
• 6:37
  Speaker 1: Wait, so you can't just run the test at your
• 6:39
  Speaker 1: preferred lab in say India or Europe and just send
• 6:42
  Speaker 1: them the results.
• 6:43
  Speaker 2: No, absolutely not. Data integrity is so crucial to them
• 6:47
  Speaker 2: that they demand home field oversight.
• 6:49
  Speaker 1: That is intense, okay.
• 6:50
  Speaker 2: And the third length, the third pathway is the reference
• 6:53
  Speaker 2: country based registration. This is an option if your drug
• 6:56
  Speaker 2: is already approved in one of BPM's designated highly read
• 7:00
  Speaker 2: regulated reference countries.
• 7:01
  Speaker 1: So places like the US, EU Member States, Japan, Australia, Canada, or.
• 7:05
  Speaker 2: The UK exactly.
• 7:07
  Speaker 1: Okay, hold on, if I have that reference country approval,
• 7:09
  Speaker 1: doesn't that mean I get to skip to the front
• 7:11
  Speaker 1: of the line, like I just show them my FDA
• 7:13
  Speaker 1: approval and bypass the headache approving the drug works all
• 7:16
  Speaker 1: over again.
• 7:17
  Speaker 2: I have to offer a very strict reality check on
• 7:19
  Speaker 2: that assumption.
• 7:20
  Speaker 1: Let's hear it.
• 7:20
  Speaker 2: The reference pathway is incredibly valuable, don't get me wrong,
• 7:23
  Speaker 2: because it drastically reduces the clinical evidence burden.
• 7:26
  Speaker 1: Right because you're relying on the reference country's clinical assessment exactly.
• 7:31
  Speaker 2: But it absolutely does not eliminate the local administrative, labeling
• 7:36
  Speaker 2: or manufacturing compliance requirements.
• 7:38
  Speaker 1: Ah, So you still have to play by bpom's notoriously
• 7:42
  Speaker 1: strict local rules for everything outside the clinical trial data.
• 7:46
  Speaker 2: You do, which brings us to the administrative gauntlet of
• 7:49
  Speaker 2: the act D dossier, specifically Part one.
• 7:52
  Speaker 1: The Administrative and Product Information section. This seems to be
• 7:55
  Speaker 1: where the most agonizing local demands live. I like to
• 7:58
  Speaker 1: call this the translation.
• 8:00
  Speaker 2: The translation trap. That is the perfect way to frame.
• 8:02
  Speaker 1: It, because a foreign manufacturer might assume, right that they
• 8:05
  Speaker 1: can just take their FDA approved package insert, hand it
• 8:09
  Speaker 1: to a commercial translation agency to convert it into Bahasa
• 8:11
  Speaker 1: Indonesia and just hit submit.
• 8:13
  Speaker 2: Right, But doing that practically guarantees a rejection. Wow, just
• 8:17
  Speaker 2: an automatic rejection absolutely, because BPOM requires a highly specific,
• 8:22
  Speaker 2: structurally unique document called the RKAP, the.
• 8:26
  Speaker 1: Ring casan characteristic product right.
• 8:28
  Speaker 2: It is not a direct translation of an FDA label.
• 8:31
  Speaker 2: It is a completely distinct document drafted using bpom's exact
• 8:36
  Speaker 2: prescribed content structure, and crucially, they're approved pharmaceutical lexicon.
• 8:41
  Speaker 1: Let's explain why they are so militant about this. I mean,
• 8:44
  Speaker 1: Indonesia is a massive archipelago with hundreds of distinct local dialects. Yes,
• 8:50
  Speaker 1: so if a translation agency translates in English medical instruction
• 8:54
  Speaker 1: like take on an empty stomach using a colloquial phrase.
• 8:58
  Speaker 1: A doctor in a remote province, I'd interpret it totally
• 9:01
  Speaker 1: differently than a doctor.
• 9:02
  Speaker 2: In the capital, exactly, and that ambiguity could literally lead
• 9:05
  Speaker 2: to a fatal medical error.
• 9:07
  Speaker 1: So BPOM forces everyone to use one standardized, rigid medical vocabulary, exactly.
• 9:13
  Speaker 2: It's entirely about eliminating interpretive risk. If you don't use
• 9:15
  Speaker 2: their exact terminology on your primary packaging, your secondary packaging,
• 9:19
  Speaker 2: and your patient inserts, you fail the review.
• 9:22
  Speaker 1: And that's just the language piece. The administrative demands cascade
• 9:25
  Speaker 1: into international legal documentation too, like you must provide CPPs right.
• 9:29
  Speaker 2: Yes, certificates a pharmaceutical product issued by your national health authority,
• 9:34
  Speaker 2: but BPOM demands that these be apostled.
• 9:38
  Speaker 1: And for those not living and breathing international regulatory law,
• 9:41
  Speaker 1: an apostle is essentially an internationally recognized notorization. It's this
• 9:46
  Speaker 1: highly specialized legal seal proving the document isn't a forgery, right.
• 9:52
  Speaker 2: And obtaining that seal takes real time. BPOM has rejected
• 9:55
  Speaker 2: entire submissions just because of formatting quirks on an.
• 9:59
  Speaker 1: Apostle seriously just formatting, yeah, or.
• 10:02
  Speaker 2: Because the certificate didn't explicitly detail the exact scope of
• 10:05
  Speaker 2: the manufacturing site. And speaking of manufacturing, BPOM requires valid
• 10:10
  Speaker 2: Good Manufacturing Practice GMP certificates for every single facility involved
• 10:15
  Speaker 2: in the drugs creation.
• 10:16
  Speaker 1: Okay, let's visualize that supply chain for a second. Imagine
• 10:19
  Speaker 1: a company synthesizes the active chemical ingredient in lab in India,
• 10:23
  Speaker 1: ships it to Italy to be manufactured into a pill,
• 10:26
  Speaker 1: and then ships those pills to the UK to be
• 10:28
  Speaker 1: placed into blister packs.
• 10:29
  Speaker 2: In that scenario, BPOM requires a recognized, valid GMP certificate
• 10:33
  Speaker 2: for the site in India, the site in Italy, and
• 10:36
  Speaker 2: the site in the UK.
• 10:37
  Speaker 1: Every single node.
• 10:38
  Speaker 2: Every single node in the global supply chain must be
• 10:41
  Speaker 2: documented and proven compliant to their standards. If even one
• 10:46
  Speaker 2: secondary packaging site lacks the proper paperwork, the entire registration halts.
• 10:51
  Speaker 1: So you managed to get your paperwork apostled, you translated
• 10:54
  Speaker 1: it into the perfect RKP terminology, and you've mapped out
• 10:58
  Speaker 1: the GMP certificates for you your entire supply chain.
• 11:01
  Speaker 2: You're doing great so far.
• 11:02
  Speaker 1: Right, But surviving that administrative gauntlet doesn't mean your actual
• 11:06
  Speaker 1: physical product will survive the Indonesian environment exactly, which brings
• 11:10
  Speaker 1: us to part two of the dossier, and this is
• 11:13
  Speaker 1: arguably the most fascinating geographic reality check in the entire process.
• 11:18
  Speaker 1: I'm talking about the climate catch ah.
• 11:20
  Speaker 2: Yes, the Zone ivive stability requirement. This is where global
• 11:25
  Speaker 2: pharmaceutical science aggressively collides with the reality of tropical geography.
• 11:29
  Speaker 1: It's geographical reality checking clinical science. It's essentially like trying
• 11:33
  Speaker 1: to sell a winter coat in the desert. Right. If
• 11:35
  Speaker 1: a massive global pharma company develops a new drug in
• 11:39
  Speaker 1: say northern Europe or the northern US, they physically tested
• 11:43
  Speaker 1: that pill's stability, how long it lasts on a shelf
• 11:46
  Speaker 1: based on their own local weather. Correct.
• 11:48
  Speaker 2: The pharmaceutical world is divided into climatic zones to standardize
• 11:52
  Speaker 2: this testing, So markets in the European Union in North
• 11:55
  Speaker 2: America generally fall under Zone IBA or Zone three conditions.
• 11:59
  Speaker 1: Okay, And in practical terms, what does that mean?
• 12:01
  Speaker 2: That means the manufacturer tested the drugs shelf life in
• 12:04
  Speaker 2: environmental chambers set to around thirty degrees celsius and sixty
• 12:08
  Speaker 2: five percent relative humidity.
• 12:10
  Speaker 1: But Indonesia sits right on the equator. I mean it
• 12:12
  Speaker 1: is a tropical archipelago.
• 12:14
  Speaker 2: Right, which places it firmly in climatic Zone IVB. So
• 12:17
  Speaker 2: BPOM mandates that you provide physical stability data generated under
• 12:22
  Speaker 2: Zone IV conditions, which are what that means proving your
• 12:24
  Speaker 2: drug remains safe and effective after sitting in an environment
• 12:27
  Speaker 2: of forty degrees celsius and seventy five percent relative humidity
• 12:31
  Speaker 2: for months.
• 12:32
  Speaker 1: Just think about the physical mechanics of that intense, relentless
• 12:35
  Speaker 1: heat and suffocating moisture at forty degrees celsius in high humidity.
• 12:39
  Speaker 1: Chemical compounds degrade much faster.
• 12:41
  Speaker 2: They absolutely do.
• 12:43
  Speaker 1: The active pharmaceutical ingredient could break down and become toxic,
• 12:46
  Speaker 1: or I don't know, the binders holding a tablet together
• 12:50
  Speaker 1: could literally melt and crumble.
• 12:52
  Speaker 2: That is the exact hazard BPOM is guarding against. If
• 12:55
  Speaker 2: a manufacturer simply submits their European Zone IVA stability data,
• 13:00
  Speaker 2: BPOM outright rejects it.
• 13:02
  Speaker 1: Because it doesn't prove anything for their climate.
• 13:04
  Speaker 2: Exactly, that data does not prove the drug will survive
• 13:08
  Speaker 2: sitting in a non air conditioned warehouse in Jakarta or
• 13:11
  Speaker 2: in a patient's human bathroom cabinet in Bali.
• 13:14
  Speaker 1: So what do foreign manufacturers have to do?
• 13:16
  Speaker 2: They are forced to conduct specific Zone IVB bridging studies,
• 13:20
  Speaker 2: and I have to say this is one of the
• 13:22
  Speaker 2: most chronically underestimated technical requirements in the entire process.
• 13:26
  Speaker 1: I can imagine you can't fake time.
• 13:28
  Speaker 2: Right, you cannot speed up time. Generating six months or
• 13:31
  Speaker 2: twelve months of new physical stability data takes exactly six
• 13:34
  Speaker 2: or twelve months. If you don't factor that into your
• 13:37
  Speaker 2: global launch strategy, your timeline is instantly destroyed.
• 13:41
  Speaker 1: Okay, so let's say a company actually did the homework.
• 13:43
  Speaker 1: They have the competent local partner, they conquered the translation trap,
• 13:46
  Speaker 1: they possess the apostleed certificates for every manufacturing node, and
• 13:50
  Speaker 1: they spent the time generating that punishing Zone IV climate data.
• 13:55
  Speaker 2: They've done everything right.
• 13:56
  Speaker 1: They compile the dossier, they hit submit. You'd think the
• 13:59
  Speaker 1: heart part is over, but the waiting game they enter
• 14:02
  Speaker 1: is incredibly deceptive very.
• 14:05
  Speaker 2: The submission process happens entirely through bpom's erege portal, and
• 14:10
  Speaker 2: the required level of fastidiousness here.
• 14:12
  Speaker 1: Is ruthless, ruthless how well.
• 14:15
  Speaker 2: You upload your dossier as a series of PDF documents.
• 14:18
  Speaker 2: BPOM enforces exact character specific file naming conventions.
• 14:24
  Speaker 1: We mentioned this earlier.
• 14:25
  Speaker 2: Character specific Yes, if you upload a file with a
• 14:27
  Speaker 2: misplaced underscore or a title that deviates slightly from their manual.
• 14:31
  Speaker 2: The system flags it. Your submission can be rejected during
• 14:34
  Speaker 2: the initial ten day administrative screening period.
• 14:37
  Speaker 1: Just let that sync in. A multi billion dollar drug
• 14:40
  Speaker 1: backed by thousands of pages of groundbreaking clinical science, rejected
• 14:45
  Speaker 1: before a human scientist even glances at it all because
• 14:49
  Speaker 1: of a typo and a file name.
• 14:50
  Speaker 2: It is a purely binary system. At that stage, you
• 14:53
  Speaker 2: either comply perfectly or you are out unreal.
• 14:56
  Speaker 1: But okay, let's assume you survive the administrative screening and
• 15:00
  Speaker 1: enter the substantive scientific review.
• 15:02
  Speaker 2: Right, and BPOM is transparent. Here they publish parget timelines
• 15:06
  Speaker 2: for these reviews. For new drugs, the published target is
• 15:09
  Speaker 2: three hundred working days. For generics it's one hundred working days,
• 15:13
  Speaker 2: and for reference country submissions it's one hundred and fifty
• 15:16
  Speaker 2: working days.
• 15:17
  Speaker 1: Wait, let's see the map on that three hundred working
• 15:19
  Speaker 1: days is just over a calendar year. That is a
• 15:22
  Speaker 1: completely manageable timeframe. You can build a one year regulatory
• 15:26
  Speaker 1: review into a corporate launch calendar, you'd think, so, so,
• 15:29
  Speaker 1: why are global companies constantly complaining that Indonesian registrations actually
• 15:33
  Speaker 1: take twenty four to thirty six months. Where are those
• 15:36
  Speaker 1: missing years coming from?
• 15:37
  Speaker 2: Those missing years come from a bureaucratic mechanism known as
• 15:40
  Speaker 2: the stock clock. The stock clock, Yes, officially, this is
• 15:44
  Speaker 2: triggered by the syrup permantown tombihand data that translates to
• 15:48
  Speaker 2: the formal request for additional data.
• 15:49
  Speaker 1: Okay, so how exactly does the stop clock work.
• 15:52
  Speaker 2: So whenever bpom's scientific evaluators are reviewing EARD dossier and
• 15:58
  Speaker 2: they find a gap, maybe an inconsistent and see in
• 16:00
  Speaker 2: your RKP terminology or a missing GMP certificate from that
• 16:05
  Speaker 2: secondary packaging site in the UK we mentioned earlier.
• 16:08
  Speaker 1: Or a flaw in your Zone IVB climate data.
• 16:10
  Speaker 2: Exactly if they find any of that, they issue a
• 16:12
  Speaker 2: formal request and the very second that request is issued,
• 16:16
  Speaker 2: your three hundred day countdown clock pauses, it completely.
• 16:21
  Speaker 1: Freezes, and the manufacturer is suddenly on the defensive.
• 16:23
  Speaker 2: Yes, you are given a strict sixty working day window
• 16:26
  Speaker 2: to respond and rectify the issue, which sounds like enough time,
• 16:29
  Speaker 2: But think about the complexity of the issues BPM raises
• 16:33
  Speaker 2: if they demand a new physical stability test or require
• 16:37
  Speaker 2: you to source a newly apostled legal document from a
• 16:39
  Speaker 2: European health ministry. You often cannot achieve that within sixty.
• 16:43
  Speaker 1: Days, oh man. So manufacturers have to beg for extensions.
• 16:46
  Speaker 2: They do, and VPLM doesn't just issue one of these requests.
• 16:49
  Speaker 2: They can issue multiple rounds of them.
• 16:51
  Speaker 1: So let me get this straight. Every time they find
• 16:53
  Speaker 1: a discrepancy, the clock stops. He's been three months fixing it.
• 16:56
  Speaker 1: The clock starts again. They find another issue, The clock
• 16:58
  Speaker 1: stops again. The pattern that cascading delay is how a
• 17:02
  Speaker 1: highly predictable three hundred day target mutates into a grueling,
• 17:07
  Speaker 1: unpredictable three year nightmare.
• 17:09
  Speaker 2: Precisely, the stop clock is the ultimate test of how
• 17:12
  Speaker 2: well you prepared your dossier before hitting submit. If your
• 17:15
  Speaker 2: local partner isn't meticulously managing that process, the delays become infinite.
• 17:20
  Speaker 1: Okay, let's look at the best case scenario. A company
• 17:23
  Speaker 1: endures the stop clocks, they satisfy every single scientific inquiry,
• 17:27
  Speaker 1: and BPOM finally grants the local partner that golden tunnet,
• 17:31
  Speaker 1: the NIE marketing authorization.
• 17:33
  Speaker 2: The holy grail.
• 17:35
  Speaker 1: The drug is legally approved for sale in Indonesia, but
• 17:38
  Speaker 1: the regulatory burden doesn't evaporate the moment the product hits
• 17:41
  Speaker 1: the pharmacy shelves.
• 17:42
  Speaker 2: Does it not at all? The post market reality in
• 17:44
  Speaker 2: Indonesia is just as rigorous as the pre market submission.
• 17:47
  Speaker 2: BPOM maintains intense surveillance overprooved products.
• 17:51
  Speaker 1: Like the pharmacovigilance we talked about earlier.
• 17:53
  Speaker 2: Exactly if a serious adverse drug reaction occurs once the
• 17:57
  Speaker 2: drug is out in the public, your local registration holder
• 18:00
  Speaker 2: must report it to BPOM within fifteen calendar.
• 18:02
  Speaker 1: Days with calendar days not working days.
• 18:05
  Speaker 2: Calendar days. That requires an always on, highly responsive safety
• 18:09
  Speaker 2: monitoring system.
• 18:10
  Speaker 1: Okay, And what if the company wants to tweak the
• 18:12
  Speaker 1: product later, say they redesign the cardboard box it comes in,
• 18:17
  Speaker 1: or they add a new manufacturing facility in a different
• 18:19
  Speaker 1: country just to keep up with demand.
• 18:21
  Speaker 2: You cannot simply implement those changes. Even for minor administrative
• 18:25
  Speaker 2: tweaks to the labeling or adding a new manufacturing site.
• 18:29
  Speaker 2: You must submit a formal variation application to BPOM.
• 18:33
  Speaker 1: So more waiting a lot more.
• 18:35
  Speaker 2: You have to wait for them to officially approve the
• 18:38
  Speaker 2: variation before you can physically ship the newly packaged or
• 18:41
  Speaker 2: newly manufactured drug into the country.
• 18:43
  Speaker 1: Wow.
• 18:44
  Speaker 2: Furthermore, for many new drugs. BPOM attaches Phase four post
• 18:48
  Speaker 2: market safety study commitments to the NIE, so you are
• 18:52
  Speaker 2: legally bound to conduct ongoing clinical observations in the Indonesian
• 18:55
  Speaker 2: population and submit those reports on strict deadlines.
• 18:59
  Speaker 1: So synthesizing all these layers for you listening, Succeeding in
• 19:02
  Speaker 1: Indonesia's massive pharmaceutical market requires nothing short of radical localization.
• 19:07
  Speaker 2: That's the perfect term for it.
• 19:09
  Speaker 1: You absolutely cannot recycle your global data translated on the
• 19:13
  Speaker 1: cheap and expect it to fly. You need a highly competent,
• 19:17
  Speaker 1: scientifically fluent local partner who absorbs your legal liability. You
• 19:22
  Speaker 1: need culturally and structurally perfect.
• 19:24
  Speaker 2: Labeling yep unbrick and chain of international manufacturing documentation exactly.
• 19:29
  Speaker 1: And you need the physical zone IVB science to prove
• 19:33
  Speaker 1: your drug can survive the reality of the equatorial climate.
• 19:36
  Speaker 2: Investing deeply in that localized depth upfront is literally the
• 19:40
  Speaker 2: only way to prevent the stop clock from destroying your
• 19:42
  Speaker 2: launch timeline. Right But even after you achieve all of that,
• 19:45
  Speaker 2: there is one final detail regarding the NIE that dictates
• 19:48
  Speaker 2: long term strategy. The marketing authorization you fought years to obtain.
• 19:52
  Speaker 2: It is only valid for five years.
• 19:54
  Speaker 1: Only five years. So it's not a permanent deed to
• 19:56
  Speaker 1: a house. It's a five year lease exactly.
• 19:59
  Speaker 2: And renewal is absolutely not automatic. You have to proactively
• 20:02
  Speaker 2: compile and submit renewal paperwork well before that five year
• 20:06
  Speaker 2: term expires. And if you miss it, if you miss
• 20:08
  Speaker 2: that deadline and the NIE lapses, BPOM effectively evicts you
• 20:12
  Speaker 2: from the market. You cannot simply pay a late fee
• 20:15
  Speaker 2: and reactivate it. Oh my god, you.
• 20:17
  Speaker 1: Have to start the entire multi year grueling registration process
• 20:22
  Speaker 1: completely from scratch. Wow.
• 20:24
  Speaker 2: Just let the gravity that sink in for a moment.
• 20:26
  Speaker 2: Think about the scale of global business. How many multimillion
• 20:31
  Speaker 2: dollar pharmaceutical supply chains, how many massive corporate expansions into
• 20:36
  Speaker 2: Southeast Asia are currently hanging.
• 20:38
  Speaker 1: By a thread too many?
• 20:40
  Speaker 2: All of that infrastructure, all of that projected revenue is
• 20:43
  Speaker 2: entirely dependent on one local partner sitting in an office
• 20:47
  Speaker 2: in Jakarta remembering to hit submit on a single administrative
• 20:50
  Speaker 2: calendar deadline before the clock strikes zero.
• 20:53
  Speaker 1: It is the ultimate proof that in the global health sector,
• 20:56
  Speaker 1: local context isn't just a detail. It is the only
• 20:59
  Speaker 1: thing that matters.
• 21:00
  Speaker 2: It really is. I mean, a missing PDF underscore or
• 21:02
  Speaker 2: a forgotten calendar date can undo decades of brilliant science.
• 21:06
  Speaker 2: Thanks for joining us in the Knowledge Capsule. Until next time,
• 21:08
  Speaker 2: keep digging deeper.