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 think it’s just a cheaper version of the brand-name drug. But behind that simple label lies one of the most complex regulatory systems in the world. In 2025, the European Union’s approach to generic medicines is changing faster than ever-reshaping how drugs reach patients, how companies compete, and how quickly prices drop. The system isn’t broken, but it’s far from simple. And if you’re trying to bring a generic drug to market in Europe, you’re not just dealing with one set of rules. You’re navigating four different pathways, 27 national bureaucracies, and a major overhaul that just took effect.

Four Ways to Get a Generic Drug Approved in the EU

There’s no single path to launch a generic medicine in the EU. Instead, manufacturers must choose from four approval routes, each with different costs, timelines, and risks. The choice isn’t just logistical-it’s strategic.

The Centralized Procedure is the fastest route to EU-wide access. 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. Sounds ideal, right? But it’s also the most expensive. Application fees alone hit €425,000, and with consultancy, testing, and documentation, total costs can climb to €1.8 million. That’s only worth it for high-volume drugs expected to earn over €250 million annually across the bloc. Sandoz used this route to launch its version of Novartis’s Cosentyx in Q2 2025-11 months faster than any other method allowed.

The Mutual Recognition Procedure (MRP) is the middle ground. You get approval in one country first-the Reference Member State-then ask others to recognize it. About 42% of generics use this route. It’s cheaper than the Centralized Procedure, costing between €180,000 and €220,000. But it’s slower than it should be. Even though the official clock says 90 days for consensus, the average takes 132.7 days. Why? Because countries keep adding their own demands. Teva’s generic rosuvastatin got approved in Germany but waited 8.2 months before hitting the Dutch and Belgian markets due to pricing delays.

The Decentralized Procedure (DCP) lets you apply to multiple countries at once. It’s used by 38% of applicants. But it’s messy. The Reference Member State leads the review, but other countries can raise objections-and each objection resets the 210-day clock. In 2024, 37% of DCP applications faced delays over six months, mostly because Eastern European regulators interpreted quality standards differently. One case study from the GMDP Academy showed a single impurity threshold dispute delayed approval in five countries for nine months.

The National Procedure is the simplest-but also the most limited. You apply only to one country. It’s used for just 5% of applications, mostly when a company wants to test the waters in a high-reimbursement market like France. But it doesn’t help with scale. Accord Healthcare took 197 days to get approval in France via this route-while using MRP, they got the same drug approved across five countries in 142 days.

What the EU Pharma Package 2025 Changed

On June 4, 2025, the EU passed its biggest update to generic drug rules in 20 years: the Pharma Package. It didn’t just tweak a few forms. It rewrote the game.

One of the biggest shifts is the expanded Bolar exemption. Before, generic makers could start negotiating prices and reimbursement only two months before a patent expired. Now, they can start six months earlier. That’s not just a technical change-it’s a power shift. Payers now have more time to compare prices, and manufacturers have to submit their HTA dossiers earlier. REMAP Consulting estimates this alone will cut generic launch delays by 4.3 months on average. But there’s a catch: earlier entry means more competition before launch, which could drive down prices by 12-18%.

Another major change is the reduction in data protection. Previously, originator companies had 10 years of exclusivity (8 years of data protection + 2 years of market exclusivity). Now, it’s 8 years of data protection + 1 year of market protection-with a possible one-year extension if the drug meets public health targets. That means generics can enter sooner. Evaluate Pharma predicts this will speed up access for 78 high-value biologics currently in development.

There’s also a new obligation to supply rule. Companies can’t just stop making a generic because it’s not profitable. If a drug is on the EU’s list of critical medicines, manufacturers must keep producing it in “sufficient quantities.” But here’s the problem: each country defines “sufficient” differently. Professor Panos Kanavos of LSE Health warns this could lead to artificial shortages in smaller markets if regulators interpret the rule too loosely.

Why National Differences Still Matter

Even with harmonization efforts, national regulators still call the shots on key details. The EMA sets the baseline-but countries add their own layers.

Germany’s BfArM requires extra pharmacodynamic studies for complex generics like inhalers, even if the EMA says they’re not needed. France’s ANSM demands specific pediatric formulation data that other countries don’t require. Poland and Romania have stricter rules for impurity profiles in older reference products. A 2025 survey by the Association of the British Pharmaceutical Industry found that 68% of generic companies saw inconsistent bioequivalence requirements across borders as their biggest headache.

And then there’s documentation. By 2026, all product information must be submitted electronically in XML format. That means companies need new software, training, and IT support. White & Case estimates this will cost €180,000-250,000 per company to implement. Smaller firms are feeling the pressure.

Even the EMA’s own guidance isn’t always followed. A 2025 industry survey showed 58% of respondents got conflicting answers from national authorities compared to EMA guidelines-especially around impurity limits and stability testing. One company spent 11 months chasing down a single impurity threshold that varied by country, even though the EMA had approved the drug.

Who’s Winning in the EU Generic Market?

The EU generic market was worth €42.7 billion in 2024, growing 6.2% from the year before. But the winners aren’t who you might expect.

Indian manufacturers now hold 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. Meanwhile, European firms like Sandoz and Viatris still control 52% of the market-not because they’re cheaper, but because they play the long game. They use the Centralized Procedure to launch across the entire EU at once, avoiding the delays of national negotiations.

Eastern Europe is the fastest-growing region, with generic sales rising 9.8% annually. That’s partly because prices are lower, and reimbursement systems are expanding. But it’s also because regulators there are more open to accepting generics approved elsewhere-making it easier for companies to use MRP or DCP to enter the region.

And the US-EU Framework Agreement, effective September 1, 2025, could change the game again. It adjusts tariffs on key pharmaceutical ingredients. The exact impact isn’t clear yet, but if it lowers costs for API imports, it could give Indian and Chinese manufacturers an even bigger edge.

What’s Next for Generic Manufacturers?

If you’re planning to launch a generic in Europe in 2025 or beyond, here’s what you need to do:

• Choose your pathway carefully. If your drug will sell over €250 million in the EU, go Centralized. If you’re targeting 3-5 countries, use MRP. Avoid DCP unless you’re confident in your regulatory team’s ability to handle national objections.
• Start early. The EMA now recommends 15-18 months of preparation for Centralized submissions. That includes 6-8 months just for bioequivalence studies under the 2025 guidelines.
• Prepare for price pressure. With the Bolar exemption, you’ll be negotiating with payers six months before launch. Have your HTA dossier ready. Know your cost structure. Don’t assume you’ll get the same price everywhere.
• Invest in compliance. The move to ePI in XML format isn’t optional anymore. Budget for software, training, and audits. One company missed the 2026 deadline and had to delay three launches.
• Watch the list. The Critical Medicines Act now includes 200 essential generics. If your drug is on it, you’ll need to prove you can supply it consistently-or risk being blocked.

The EU’s goal is clear: more generics, faster access, lower prices. But the system isn’t designed for speed-it’s designed for safety. And that means complexity. The companies that win won’t be the ones with the cheapest pills. They’ll be the ones who understand the rules, adapt to the changes, and play the long game.

What Happens After 2026?

The big changes don’t stop in 2025. On July 1, 2026, the revised Regulatory Data Protection rules fully kick in. That’s when the 8+1 protection period becomes standard. That means more generics will enter the market sooner-especially for complex drugs that were previously protected for longer.

But there’s a risk. Professor Kanavos points out that the 1-year default market protection may discourage investment in complex generics like biosimilars for rare diseases. If the return isn’t worth the cost, companies might walk away. That could create new access gaps.

The EU is trying to balance innovation and affordability. But the tension remains. As generic manufacturers adapt, the real question isn’t just how fast they can get approved-it’s whether the system will still be able to deliver the medicines patients need, when they need them.

Generic drugs are no longer just about saving money-they’re about navigating a shifting legal landscape, managing national differences, and staying ahead of regulatory deadlines. The EU’s system isn’t perfect, but it’s getting smarter. The companies that succeed will be those who treat regulation not as a barrier, but as part of their strategy.