European Generic Markets: Regulatory Approaches Across the EU in 2025

• by Simon Bruce
• Nov, 22 2025

When a patient in Germany, Poland, or Spain picks up a generic version of a blood pressure pill, they’re not just getting a cheaper alternative-they’re benefiting from one of the most complex drug approval systems in the world. The European Union’s approach to generic medicines isn’t a single rulebook. It’s a patchwork of four different pathways, each with its own rules, costs, and delays. And in 2025, everything changed.

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

There’s no one-size-fits-all way to get a generic drug approved across the EU. Generic manufacturers must choose from four routes, each suited to different goals, budgets, and target markets.

The Centralized Procedure is the fastest way to reach all 27 EU countries at once. A single application goes to the European Medicines Agency (EMA). If approved, the drug can be sold everywhere from Portugal to Finland. But it’s expensive-application fees alone cost around €425,000, with total setup costs between €1.2 million and €1.8 million. Only companies with high-volume products-those expected to sell over €250 million across the EU-usually make this investment. Sandoz used this route to launch its version of Novartis’s Cosentyx in Q2 2025, hitting all markets simultaneously-11 months faster than other methods allowed.

The Mutual Recognition Procedure (MRP) is the most popular choice, used in 42% of cases. A company gets approval in one country first (the Reference Member State), then asks others to recognize it. Sounds simple, right? In practice, it’s messy. Even after technical approval, national pricing talks can drag on. Teva’s generic rosuvastatin got approved in Germany in 2023, but didn’t launch in the Netherlands or Belgium until 8.2 months later because of reimbursement delays. The process officially takes 90 days, but on average, it lasts 132.7 days.

The Decentralized Procedure (DCP) lets companies apply to multiple countries at the same time. No prior approval needed. But coordination is a nightmare. Each country interprets quality rules differently. In Eastern Europe, some authorities demand extra stability data or reject bioequivalence studies that other countries accept. A 2024 GMDP Academy study found 37% of DCP applications faced delays longer than six months. The official timeline is 210 days, but the real average is 247.

The National Procedure is the simplest-but also the most limited. You apply only to one country. It’s useful if you only care about, say, France’s high-reimbursement market. But you’re stuck there. Accord Healthcare found it took 197 days to get approval in France via the national route, while using MRP to cover five countries took just 142 days.

What Makes a Generic a Generic? The Science Behind Approval

Before any of these pathways even start, the drug has to prove it’s the same as the original. Not close. Not almost. Exactly.

The EMA requires three things: identical active ingredients, identical pharmaceutical form (tablet, injection, inhaler), and proven bioequivalence. That last one is the make-or-break test. Companies must run clinical studies showing the generic drug behaves the same way in the body as the brand-name version. The standard? The 90% confidence interval for absorption (AUC) and peak concentration (Cmax) must fall between 80% and 125% of the original. No exceptions.

But here’s where things get tricky. For complex generics-like inhalers, topical creams, or injectables-some countries demand more. Germany’s BfArM requires extra pharmacodynamic studies for inhalers. France’s ANSM insists on pediatric formulation details even when the original drug wasn’t tested on children. These national add-ons aren’t in the EMA guidelines. They’re local rules. And they’re why 68% of generic companies surveyed by the ABPI in 2025 said inconsistent bioequivalence requirements were their biggest headache.

The 2025 Pharma Package: A Major Reset

On June 4, 2025, the EU passed its biggest overhaul of pharmaceutical rules in 20 years. The changes hit generics hard-and fast.

The most important change? The expanded Bolar exemption. Before, generic makers could start negotiating prices and reimbursement with health systems only two months before a patent expired. Now, they can start six months early. That’s a game-changer. REMAP Consulting’s 2025 model predicts this alone will cut generic launch delays by 4.3 months on average. It also gives payers more leverage. With earlier negotiations, competition starts sooner, and launch prices could drop 12-18%.

Another big shift: Regulatory Data Protection is being shortened. Previously, originator drugs got 10 years of protection (8 years data + 2 years market). Now, it’s 8 years data + 1 year market, with an optional one-year extension if the drug meets public health goals. This means generics can enter sooner for many drugs. Evaluate Pharma estimates 78 high-value biologics currently in development will see earlier generic competition because of this.

But it’s not all good news. The new rules introduce a €490 million sales threshold for “Transferable Exclusivity Vouchers”-a bonus period of market protection for companies that develop drugs for rare diseases. Critics say this favors big players. Mid-sized generic firms, which make up 40% of the market, may be locked out.

Who’s Winning and Who’s Struggling?

Indian manufacturers are making huge gains. In 2024, they won 38% of all EU generic approvals, up from 29% in 2020. Their low-cost production and aggressive pricing are reshaping the market.

European firms like Sandoz and Viatris aren’t falling behind. They’re playing the long game. By choosing the Centralized Procedure for high-value drugs, they avoid the delays of national negotiations. Viatris reported in its 2024 annual report that MRP coordination added €3.2 million in carrying costs per launch. That’s money spent waiting-not selling.

But even the winners face new hurdles. The 2025 reforms require all product information to be submitted electronically in XML format by 2026. That’s a €180,000-250,000 investment per company in IT systems. Smaller firms may struggle to keep up.

And then there’s the obligation to supply rule. Companies must now guarantee they can keep producing and supplying essential generics. But what counts as “sufficient quantities”? Each country decides. Professor Panos Kanavos of LSE Health warns this could lead to artificial shortages in smaller markets where demand is low but compliance costs are high.

The Bigger Picture: Why This Matters

Generics make up 65% of all prescriptions in the EU by volume, but only 18% by value. That gap shows how much money the system saves-but also how much complexity it creates.

The average delay between a drug’s patent expiry and generic launch across the EU is 11.3 months. In the U.S., it’s 4.2 months. In Canada, it’s 8.7 months. That 11.3-month gap isn’t just bureaucratic-it’s a delay in patient access to affordable medicine.

The 2025 reforms aim to fix that. With faster approvals, earlier pricing talks, and tighter supply rules, the EU expects generic market penetration to rise from 65% to 69.2% by 2028. That’s 4.2 percentage points of extra savings for public health systems.

But success depends on consistency. If Germany, Poland, and Italy keep adding their own rules on top of the EU framework, the system will remain fragmented. The goal was harmonization. The reality? Still a patchwork.

What Comes Next for Generic Manufacturers?

If you’re a generic drug maker today, here’s what you need to do:

1. Choose your pathway wisely. High-volume? Go Centralized. Target a few countries? Use MRP. Avoid DCP unless you’re prepared for delays.
2. Start preparing 15-18 months before launch. Bioequivalence studies alone take 6-8 months under the new 2025 guidelines.
3. Invest in ePI systems now. The XML requirement kicks in by 2026. Waiting will cost you.
4. Track national differences. Don’t assume EMA rules are enough. Check Germany’s BfArM, France’s ANSM, and Italy’s AIFA for local add-ons.
5. Use the EMA’s free Q&A portal-but verify every answer with your national authority. A 2025 survey found 58% of companies got conflicting info.

The EU’s generic market is worth €42.7 billion in 2024. It’s growing. But the path to profit is narrower, faster, and more technical than ever.