European Generic Markets: Regulatory Approaches Across the EU in 2025

When you pick up a generic pill at the pharmacy in Berlin, Rome, or Warsaw, you might assume it’s the same as the brand-name version. But behind that simple assumption is one of the most complex regulatory systems in the world. The European Union doesn’t have one single way to approve generic medicines-it has four, each with different rules, timelines, and costs. And in 2025, those rules are changing faster than ever before.

The Four Paths to Market: How Generics Get Approved in the EU

There’s no single route for a generic drug to reach patients across the EU. Instead, manufacturers must choose from four distinct approval pathways, each shaped by geography, cost, and strategy.

The Centralized Procedure is the fastest route to EU-wide access. A single application goes to the European Medicines Agency (EMA), and if approved, the drug can be sold in all 27 EU countries plus Iceland, Liechtenstein, and Norway. It’s used for about 15% of generic applications. The assessment used to take 210 days-now, under the 2025 Pharma Package, it’s cut to 180 days. But it’s expensive: application fees alone start at €425,000, with total costs often hitting €1.2-1.8 million. That’s only worth it for high-volume products expected to earn over €250 million annually. Sandoz used this route for its version of Cosentyx, launching across the entire EU in Q2 2025-11 months faster than traditional methods.

The Mutual Recognition Procedure (MRP) is the most popular, used in 42% of cases. A company gets approval in one country (the Reference Member State), then asks others to recognize it. Sounds simple, right? Not quite. Even though the process is supposed to take 90 days, delays push the average to 132.7 days. Why? Because countries still add their own requirements. Teva’s generic rosuvastatin got approved in Germany but waited 8.2 months to launch in the Netherlands and Belgium due to pricing negotiations-something that has nothing to do with science, but everything to do with national budgets.

The Decentralized Procedure (DCP) lets companies apply to multiple countries at once, without prior approval anywhere. It’s meant to be a middle ground, but it’s the most frustrating. Thirty-seven percent of DCP applications face delays longer than six months, mostly because Eastern European regulators interpret quality standards differently. One company reported that a single objection from a national authority resets the entire 180-day clock. That’s not efficiency-that’s chaos.

The National Procedure is the slowest and most limited. Only 5% of applications use it, because it only works in one country. It takes 180-240 days, and even then, you’re stuck with a single market. But for some, it’s strategic. If you only care about France’s high reimbursement rates, going national might make sense-even if it means missing out on the rest of Europe.

What Makes a Generic ‘Generic’? The Science Behind Approval

Before any of these pathways even start, the drug must prove it’s identical to the original. That means matching the active ingredient down to the last molecule. No more, no less. The pharmaceutical form-tablet, capsule, injection-must be the same. And most critically, it must be bioequivalent.

Bioequivalence isn’t just a buzzword. It’s a strict scientific test. The generic must deliver the same amount of medicine into the bloodstream at the same rate as the brand version. That’s measured using two metrics: Cmax (peak concentration) and AUC (total exposure). The acceptable range? 80.00% to 125.00%. If your generic falls outside that, it’s rejected. No exceptions.

And it’s not just about blood levels. For complex generics-like inhalers or injectables-some countries demand extra studies. Germany’s BfArM requires pharmacodynamic data for certain inhalers. France’s ANSM needs pediatric formulation details. These aren’t EU-wide rules. They’re national add-ons that turn a standardized process into a patchwork.

The 2025 Pharma Package: What’s Changing?

For the first time in 20 years, the EU is overhauling how generics enter the market. The new Pharma Package, finalized on June 4, 2025, introduces three major shifts.

First, Regulatory Data Protection is shrinking. Previously, originator companies enjoyed 10 years of protection-8 years of data exclusivity plus 2 years of market exclusivity. Now, it’s 8 years plus 1 year, with a possible 1-year extension if the drug meets public health goals. That means generics can enter sooner. For 78 high-value biologics in development, this could mean launches up to a year earlier.

Second, the Bolar Exemption has been expanded. Before, companies could start pricing and reimbursement talks only two months before a patent expired. Now, they can start six months before. That’s a game-changer. It lets generics negotiate with payers while the brand is still on the market, creating early competition. REMAP Consulting predicts this will cut generic launch delays by 4.3 months on average-and push prices down 12-18% due to earlier pressure from multiple suppliers.

Third, the Obligation to Supply is now legally binding. Companies must ensure there’s enough stock of essential generics to prevent shortages. But here’s the catch: each country decides what “sufficient quantities” means. Professor Panos Kanavos warns this could lead to artificial shortages in smaller markets if national authorities interpret the rule too narrowly.

Who’s Winning? The Players Behind the Numbers

The EU generic market was worth €42.7 billion in 2024, growing at 6.2%. But the winners aren’t evenly spread.

Indian manufacturers now control 38% of all EU generic approvals-up from 29% in 2020. Their low-cost production and aggressive pricing have made them dominant in volume-driven markets. But they often struggle with the complexity of the EU system. Many rely on the National Procedure or DCP, which slows their entry.

European firms like Sandoz and Viatris hold 52% of the market-not because they’re cheaper, but because they play the long game. They use the Centralized Procedure to lock in EU-wide access. They invest in regulatory teams that understand both EMA standards and national quirks. They don’t just submit applications-they build relationships with authorities.

And then there’s the new kid on the block: the Joint HTA Regulation, which went live on January 1, 2025. It means health technology assessments (HTA) for generics will now be coordinated across the EU. That should reduce duplication. But it also means companies must prepare for a single, tougher evaluation that could delay market access if they don’t get it right the first time.

Real-World Pain Points: What Generic Companies Actually Deal With

Behind every approval is a team of regulatory professionals working overtime.

A 2025 survey of 47 generic companies by the ABPI found that 68% listed inconsistent national bioequivalence requirements as their biggest headache. One company spent 11 months just resolving a dispute over impurity levels in an older generic-because the reference product’s impurity profile had never been properly documented.

Then there’s the paperwork. By 2026, all product information must be submitted in XML format as electronic product information (ePI). That means companies need new IT systems. Estimates put the cost at €180,000-250,000 per firm. For small generics, that’s a major barrier.

And don’t forget the clock. If a national authority objects to a DCP or MRP application, the 180-day assessment timer resets. One manufacturer reported that a single objection from Poland delayed their launch by 217 days. That’s not a delay-it’s a disaster for supply chains.

What’s Next? The Road to 2028

The 2025 reforms are just the beginning. By 2028, the EU expects generic prescriptions to rise from 65% to 69.2% of all prescriptions. That’s a big jump, but it’s not automatic.

Success depends on whether countries actually harmonize their practices. Right now, you can get approved in Belgium and still be blocked in Hungary over a minor documentation difference. The EU’s goal is to reduce the average gap between U.S. and EU generic launches-from 22.4 months to something closer to Canada’s 8.7 months.

The Critical Medicines Act of March 2025 adds another layer: mandatory stockpiles for 200 essential generics. That’s good for patients. But it also means new quality checks, new audits, and new costs. Smaller companies might not survive.

The real test will be whether the system becomes simpler-or just more bureaucratic. The tools are there: faster approvals, earlier negotiations, binding supply rules. But if national authorities keep adding their own rules, the system will still feel broken.

For now, the message is clear: if you want to succeed in the EU generic market, you need more than a good product. You need a strategy, deep expertise, and the patience to navigate a system that’s still trying to catch up with itself.