International Pharmacovigilance: How Global Safety Monitoring Is Being Harmonized

This system is a joke. Big Pharma writes the rules, regulators kiss their rings, and we’re supposed to believe this is about patient safety. The real goal is to cut costs and speed up approvals - not protect lives. If harmonization were truly about equity, why are low-income countries still using paper forms while CEOs get bonuses for hitting quarterly targets? This isn’t progress. It’s corporate theater dressed up in regulatory jargon.

And don’t get me started on AI. Machines can’t feel a patient’s pain. They can’t recognize when a culture of silence in a rural clinic means a death was never reported. You don’t fix systemic neglect with algorithms.

The only thing being harmonized here is the profit margin.

Thank you for this comprehensive overview. As a healthcare professional from Nigeria, I can attest that the challenges described are not theoretical - they are daily realities. Our pharmacovigilance unit operates with limited internet, outdated software, and no dedicated data entry staff. When a patient has an adverse reaction, we often rely on handwritten reports that take weeks to reach the national center.

While I appreciate the advances in E2B(R3) and AI-driven detection, these tools remain inaccessible to most of the world. The WHO’s strategy is a step in the right direction, but without immediate funding and infrastructure support, it risks becoming another well-intentioned document gathering dust on a shelf.

We do not need more guidelines. We need trained personnel, reliable electricity, and digital tools that work offline. Harmonization must include us - not just as data sources, but as equal partners.

I work in clinical trials and this is the most accurate thing I’ve read all year. The paperwork alone is insane. We had a case last month where the same adverse event got flagged in three different systems - EU, US, and Japan - and each one required a different format, even though the patient data was identical.

It’s not that people are lazy. It’s that the systems were never designed to talk to each other. The fact that we’ve gotten this far with E2B(R3) adoption is actually impressive. The real win is that signals are now detected faster - even if the process is still a mess.

Hope the WHO funding comes through. We’re one global pandemic away from another preventable disaster if this doesn’t improve.

Oh wow. So now we’re supposed to be impressed that Big Pharma is finally doing the bare minimum to not kill people? Congratulations, we’ve reached ‘not actively harming patients’ tier. How about we stop calling this ‘harmonization’ and just call it ‘corporate damage control’?

And let’s not pretend AI is some magical fix. Those models are trained on data from rich countries. They don’t know what a rural clinic in Bangladesh looks like. They don’t know that ‘dizziness’ might be reported as ‘feeling like the world is spinning’ - and that’s not in MedDRA.

Also, 76% of companies now require data science skills? Cool. So now pharmacovigilance teams have to be pharmacists, data scientists, and IT specialists - all while being paid less than a Starbucks barista.

Progress? Or just more work for fewer people?

The premise of this article is fundamentally flawed. Harmonization is not a neutral or benevolent force - it is a mechanism of regulatory capture. The ICH is dominated by Western pharmaceutical interests. Their standards reflect their internal processes, not global medical needs.

Why should a Nigerian village clinic adopt E2B(R3) when they lack basic diagnostic tools? Why should India align with U.S. definitions of ‘unexpected’ when their population has different genetic profiles and comorbidities?

This isn’t safety. It’s standardization as a tool of cultural and economic imperialism. The real risk isn’t fragmented systems - it’s forcing one-size-fits-all protocols on diverse populations.

The data shows that 74% of LMIC staff lack resources. That’s not a gap to be filled - it’s a warning that this model is fundamentally incompatible with global equity.

Stop making excuses. This isn’t about funding or infrastructure - it’s about willpower. The U.S. and EU figured out how to make this work. Why can’t Brazil, India, or Nigeria? They have the technology. They have the talent. What they lack is the political courage to prioritize patient safety over bureaucratic inertia.

Every year we delay, people die. Not because of the drugs - because of the systems that refuse to change.

WHO’s $1.8 billion gap? That’s less than what the U.S. spends on military band uniforms in a month. This isn’t a funding problem. It’s a moral failure.

Stop talking about ‘support.’ Start demanding accountability. If you’re not part of the solution, you’re part of the problem.

they told us this was for safety but i think its just a way to control what we can take. why do they need to track every little thing? what if its just a coincidence? i heard from a guy in delhi that the FDA hides side effects to protect big pharma. they dont want us to know how many people die from these pills. the real danger is not the drugs - its the surveillance.

they say ai finds signals faster - but what if the ai is trained to ignore the ones they dont want to see? i think the whole system is a lie. they just want to make us dependent on their drugs and then charge us more.

why dont they just let people decide for themselves? why do we need all this paperwork? its a trap.

I appreciate the depth of this post. As someone working in generic drug manufacturing in India, I’ve seen both sides - the chaos of unharmonized reporting and the slow, steady progress toward standardization.

The E2B(R3) adoption here is patchy, yes - but it’s improving. We’ve trained 12 staff members on digital reporting in the last year. It’s not perfect, but it’s a start.

I agree with the Nigerian commenter - infrastructure matters. But I also believe change starts small. One form at a time. One report. One hospital at a time.

Let’s not dismiss the progress because it’s incomplete. Let’s push harder to make sure the next person who gets a bad reaction doesn’t have to fight the system just to be heard.

Harmonization is American leadership. The U.S. FDA set the standard. Europe followed. Japan adapted. The rest of the world is just catching up. If you can’t meet the standard, that’s not a failure of the system - it’s a failure of your country’s priorities.

Stop asking for handouts. Start building capacity. We didn’t get here by waiting for permission. We got here by demanding excellence.

There is no global safety without American standards. Period.

I think we’re missing the bigger picture. Harmonization isn’t just about reports and AI and deadlines. It’s about dignity.

Every time a patient in Ghana has a reaction and it never makes it to a global database, they’re being told their experience doesn’t matter. Their pain isn’t data. Their voice isn’t worth tracking.

That’s the real cost of the gap - not the deaths, not the delays, but the silence.

So yes, we need funding. We need infrastructure. But we also need to stop treating low-resource countries as problems to be solved - and start treating them as partners with lived experience that could teach us something.

Maybe the next breakthrough in signal detection won’t come from an AI model trained in Boston - but from a nurse in Kampala who noticed a pattern no algorithm could see.

you think this is about safety? think again. this is a globalist plot to control medicine. the same people who made the vaccines also made these rules. they want you to believe that harmonization is good - but its just a way to lock out small manufacturers and force everyone to use their drugs. why do you think they’re pushing AI? so they can erase the truth. if a drug kills someone in india but the ai says its ‘not significant’ - who do you think decides what’s significant?

they’re not protecting you. they’re protecting their profits. and the people who believe this are the ones who will get hurt first.

wake up. this is not progress. this is control.