European Generic Markets: Regulatory Approaches Across the EU in 2025

The European Union’s generic drug market is under major change. In 2025, new rules are reshaping how generic medicines reach patients across 27 countries. These aren’t small tweaks-they’re structural shifts that affect pricing, timing, and who can enter the market. If you’re a manufacturer, pharmacist, or just someone who relies on affordable meds, you need to understand what’s happening.

How Generic Drugs Get Approved in the EU

There’s no single path to get a generic drug approved in Europe. Instead, there are four different systems, and each one changes how fast, how cheaply, and how widely a drug can be sold.

The Centralized Procedure is the fastest way to get EU-wide approval. You submit one application to the European Medicines Agency (EMA), and if approved, your drug can be sold in all 27 EU countries plus Iceland, Liechtenstein, and Norway. But it’s expensive-application fees alone cost around €425,000, and you’ll likely spend another €1.2 to €1.8 million on consultants and studies. Only big players with high-volume products-think drugs expected to sell over €250 million across the EU-can justify this route. Sandoz used this path for its version of Cosentyx and launched across Europe in Q2 2025, 11 months faster than the old methods allowed.

The Mutual Recognition Procedure (MRP) is the most popular. About 42% of generic applications use it. A company gets approval in one country first-the Reference Member State-then asks others to accept it. Sounds simple, right? Not really. Each country can still raise objections. Teva’s generic rosuvastatin got approved in Germany in early 2023, but pricing talks there delayed its launch in the Netherlands and Belgium by over eight months. The average time for MRP approval? 132.7 days, even though the official clock says 90.

The Decentralized Procedure (DCP) lets companies apply to multiple countries at once. No prior approval needed. But this is where things get messy. In 37% of cases, delays hit six months or more. Why? Because countries like Poland, Romania, or Bulgaria interpret quality rules differently than Germany or France. One company’s stability data might be fine in Paris but rejected in Warsaw. The process averages 247 days-way longer than the 210-day target.

The National Procedure is the slowest and most limited. Only 5% of applications use it. You apply to one country only. It takes 180 to 240 days. It’s only worth it if you’re targeting a single high-reimbursement market, like France or Italy. But even then, it’s often slower than MRP for multi-country launches.

What Every Generic Must Prove

No matter which route you take, you must prove your drug is identical to the original. Not just close-identical.

You need the same active ingredients, in the same amounts, in the same form-tablet, injection, inhaler, you name it. And you must prove it works the same way in the body. That’s done through bioequivalence studies. The EMA requires that the test drug’s absorption rate (Cmax) and total exposure (AUC) fall within 80% to 125% of the original drug’s numbers, with 90% confidence. No wiggle room.

But here’s where it gets complicated. Some countries demand extra tests. Germany’s BfArM requires additional pharmacodynamic studies for inhalers. France’s ANSM wants pediatric formulation details even if the original drug wasn’t tested on kids. These aren’t EU-wide rules-they’re national add-ons. A 2025 survey of 47 generic companies found that 68% listed inconsistent national requirements as their biggest headache.

The 2025 Pharma Package: Big Changes Coming

The biggest shift in two decades kicked in on June 4, 2025. The EU Pharma Package overhauled how generics enter the market.

First, data protection is shrinking. Before, a brand-name drug had 10 years of market exclusivity (8 years data protection + 2 years market protection). Now it’s 9 years total (8+1). You can stretch it to 10 years if your drug meets public health goals-like treating rare diseases or reducing hospitalizations. But that’s rare. Most generics will now face competition sooner.

Second, the Bolar exemption got a major boost. Before, generic makers could start negotiating prices and reimbursement just two months before the patent expired. Now, they can start six months early. This is huge. REMAP Consulting estimates this will cut average launch delays by 4.3 months. It also gives payers more power. Hospitals and insurers can now compare prices and demand discounts before the generic even hits shelves. That could lower launch prices by 12-18%.

Third, the obligation to supply rule now forces companies to keep enough stock to meet demand. If a generic drug disappears from shelves, regulators can fine the maker or even force them to license production to another company. This is meant to stop shortages-but it’s being implemented unevenly. Some countries define "sufficient quantities" loosely. Others are strict. Professor Panos Kanavos from LSE Health warns this patchwork could create artificial shortages in smaller markets.

Who’s Winning and Who’s Struggling

The EU generics market was worth €42.7 billion in 2024. Growth is strongest in Central and Eastern Europe-9.8% annually. But who’s making the money?

Indian companies are rising fast. They got 38% of all EU generic approvals in 2024, up from 29% in 2020. Their low-cost manufacturing and aggressive pricing make them hard to beat on simple generics.

European firms like Sandoz and Viatris still hold 52% of the market. But they’re not winning on price. They’re winning on strategy. They use the Centralized Procedure for high-value drugs. They invest in complex formulations-inhaled steroids, injectables, long-acting tablets-that are harder for Indian firms to copy. And they’re adapting to the new rules faster.

Smaller European generics companies are caught in the middle. The new €490 million sales threshold for "Transferable Exclusivity Vouchers"-a bonus incentive for hitting market targets-puts them at a disadvantage. They can’t afford the upfront costs to compete with giants. Many are shifting focus to niche markets or partnering with Indian firms to share costs.

What Manufacturers Need to Do Now

If you’re making generics for Europe, you’re facing a new reality.

First, plan ahead. The EMA now recommends 15-18 months of prep time for Centralized Procedure applications. Six to eight months of that is just for bioequivalence studies-updated to meet the 2025 guidelines.

Second, budget for tech. By 2026, you must submit all product information in XML format (ePI). That means upgrading your IT systems. White & Case estimates this costs €180,000-250,000 per company. No one’s exempt.

Third, understand national quirks. Don’t assume the EMA’s rules are the whole story. Germany wants extra stability data for polymorphic compounds. France needs pediatric documentation. Spain has stricter impurity limits for older reference drugs. You need local legal and regulatory teams in each market you target.

And don’t rely on EMA’s free Q&A portal. A 2025 survey found 58% of companies got conflicting answers from national authorities compared to EMA guidance. You’re better off hiring local consultants.

What This Means for Patients

Here’s the bottom line: patients will get more affordable drugs faster. The EU expects generic prescriptions to rise from 65% to 69.2% by 2028. That’s over 100 million more prescriptions filled with generics each year.

But it’s not all good news. Some complex drugs-like biosimilars for rare conditions-might see slower entry. The 1-year default market protection could make companies think twice about investing in hard-to-copy products. And if supply rules are enforced unevenly, patients in smaller countries could still face shortages.

The real winners? Payers-hospitals, insurers, national health systems. They’ll have more leverage to negotiate lower prices before launch. The real losers? Companies that keep doing things the old way. The era of slow, fragmented approvals is ending.

What’s Next

The next big change hits on July 1, 2026: the revised data protection rules fully kick in. That’s when 78 high-value biologics currently in development will start facing generic competition sooner than expected.

The Critical Medicines Act, passed in March 2025, adds another layer. It requires stockpiling of 200 essential generics. That sounds good-until you realize it adds new quality checks and verification steps. For small manufacturers, that’s another barrier.

And then there’s the US-EU Framework Agreement, effective September 1, 2025. It adjusts tariffs on some pharmaceutical ingredients. No one knows yet if it will lower costs or raise them. But it’s another variable in a system already under pressure.

One thing is clear: the EU’s generic market is no longer a patchwork of national rules. It’s becoming a single, complex, high-stakes game. The rules are changing. The players are shifting. And the clock is ticking.