546 Medicines Unavailable: How the Critical Medicines Act Drives Reshoring
4 min Read Time
At the start of 2026, 546 medicines appeared on Germany’s BfArM (Federal Institute for Drugs and Medical Devices) shortage list – ranging from antibiotics and antihypertensives to salbutamol inhalers for asthma patients. 80% of imported pharmaceutical active ingredients (APIs) come from just five countries, with China alone supplying 45%. In response, the EU is advancing the Critical Medicines Act to bring production back to Europe. Here’s what that means for suppliers, logistics providers, and the pharmaceutical SME sector.
The Key Takeaways
- 546 medicines in short supply: At the start of 2026, the BfArM shortage list reached an all-time high of 546 entries – up from 460 in 2025 and around 400 in 2023 (BfArM Supply Shortage Database).
- 80% of APIs sourced from five countries: China (45%), India, the USA, the UK, and Indonesia dominate global API production. A single supply disruption can paralyze medicine availability across Europe.
- Critical Medicines Act (CMA): The EU is drafting legislation to support strategic projects for API and finished-dosage-form manufacturing in Europe – including fast-track regulatory approvals and EU funding.
- Germany’s stockpiling mandate: Since 2024, pharmaceutical companies holding rebate agreements with statutory health insurers must maintain a three-month stockpile of covered medicines.
- Opportunity for SMEs: API manufacturing, pharmaceutical logistics, and packaging in Europe are high-growth markets. Companies building capacity now stand to benefit directly from EU funding.
546 Shortages: Why Medicines Are Disappearing
The BfArM shortage list documents medicines reported by manufacturers as unavailable or only partially available. With 546 entries at the start of 2026, it has hit a new record high. For comparison: there were roughly 400 entries in 2023 and fewer than 300 in 2019.
The causes are structural – not cyclical. Over the past two decades, Europe’s pharmaceutical industry has systematically relocated API manufacturing to Asia. The rationale was sound from a business perspective: lower production costs, lighter regulatory burdens, and faster approval timelines. Today’s consequence is clear: when a factory in Zhejiang shuts down – or Mumbai’s port remains gridlocked for weeks – antibiotics vanish from German pharmacies.
Affected products aren’t niche items. The shortage list includes standard therapies: amoxicillin, children’s ibuprofen syrup, antihypertensives like candesartan, and salbutamol inhalers for asthma patients. These are medicines prescribed daily in thousands of medical practices. Shortages don’t impact isolated individuals – they undermine basic healthcare provision.
Critical Medicines Act: Europe’s Answer to Strategic Dependence
The EU has acknowledged the problem and is advancing the Critical Medicines Act (CMA). The Commission’s proposal was published in March 2025; the Council adopted its position in December 2025; and the European Parliament voted in January 2026. A political agreement is expected during 2026, with full implementation scheduled for 2027.
The CMA deploys three levers to re-establish pharmaceutical manufacturing in Europe:
1. Strategic Projects: The EU will identify critical APIs and medicines where dependence on third countries is especially acute. Fast-track authorisation procedures will apply to their European production – cutting approval times from years to months.
2. EU Funding: Multiple funding instruments are already in place: STEP (Strategic Technologies for Europe Platform), EU4Health, InvestEU, and Horizon Europe. Exact funding volumes will be defined in the final regulation – but signals from Brussels are unambiguous: billions of euros are on the table.
3. Monitoring & Early Warning: A pan-European surveillance system will detect supply disruptions early and coordinate production capacity across member states. Modeled on the HERA mechanism deployed during the COVID-19 pandemic, this system will be permanent – and expanded to cover the entire medicines market.
“80% of API imports come from just five countries. That isn’t diversification – it’s strategic vulnerability.” – European Commission, Explanatory Memorandum to the Critical Medicines Act (March 2025)
Germany: Stockpiling as an Immediate Measure
Independent of the CMA, Germany has already acted. Since 2024, pharmaceutical companies holding rebate agreements with statutory health insurers must hold a three-month stockpile of relevant medicines. The rule aims to prevent short-term production halts from triggering immediate shortages.
In practice, stockpiling helps absorb brief disruptions – but does nothing to resolve the underlying structural issue. If an API is no longer manufactured anywhere in Europe, even a three-month reserve becomes useless once depleted. Stockpiling merely shifts risk forward in time – it doesn’t eliminate it.
For logistics firms and wholesale distributors, however, the stockpiling requirement has delivered a positive side effect: demand for temperature-controlled pharmaceutical warehousing and GDP-compliant distribution has surged. Companies expanding or establishing dedicated pharma-logistics capacity are entering a market with guaranteed demand.
Where Opportunities Lie for SMEs
The Critical Medicines Act is more than regulation – it’s a stimulus programme for European pharmaceutical suppliers. Its explicit support for API manufacturing, contract manufacturing, and packaging within the EU creates commercial opportunities across three domains:
API Manufacturing: Chemistry and pharmaceutical SMEs currently serving other industries can use EU funding to build API production lines. Margins in API manufacturing exceed those in commodity chemistry – and demand is politically secured by the CMA.
Pharmaceutical Logistics: The combination of mandatory stockpiling, rising domestic production volumes, and strict GDP requirements is driving demand for specialised pharma logistics. Cold-storage facilities, track-and-trace systems, and serialisation capabilities are growth segments.
Contract Manufacturing & Packaging: As API production returns to Europe, formulation and packaging will follow. Contract Manufacturing Organisations (CMOs) in Germany – GMP-certified and FDA-audit-ready – are becoming highly sought-after partners.
For all three areas, the conditions are unprecedented: EU funding is available, fast-track approvals are imminent, and political backing is stronger than ever. Companies building capacity over the next 12 months will enter a market propelled simultaneously by regulation and real-world demand – a rare alignment.
What Companies Should Assess Right Now
Reshoring pharmaceutical production to Europe won’t happen overnight – but the foundations are being laid today. For SMEs in chemistry, logistics, and packaging, a systematic assessment is well worth the effort.
First: Audit your existing competencies. Companies already operating GMP-certified production facilities, mastering chemical synthesis, or offering GDP-compliant logistics hold a distinct advantage. The barrier to entry into pharmaceutical supply is lower than many SMEs assume – especially with EU funding offsetting investment costs.
Second: Screen available funding instruments. While CMA-specific funding programmes are still being finalised, existing mechanisms – including EU4Health and Horizon Europe – are already operational. Companies preparing funding applications now will be in pole position when the CMA enters force in 2027.
Third: Forge partnerships with pharmaceutical companies. Major generics manufacturers are actively seeking European production partners. SMEs establishing long-term contracts – as CMOs or logistics service providers – with originator or generic firms secure stable off-take agreements, significantly reducing entrepreneurial risk.
The 546 medicines on the BfArM shortage list are not an abstract regulatory concern. They represent a tangible supply risk for millions of patients – and simultaneously serve as a powerful market signal: Europe needs its own production capacity, and it is prepared to pay for it. The Critical Medicines Act transforms political intent into a concrete funding programme. SMEs treating this seriously will find themselves at the intersection of political will, regulatory support, and genuine market demand.
Frequently Asked Questions
Why are so many medicines unavailable in Germany?
The primary cause is the relocation of API manufacturing to Asia. 80% of imported pharmaceutical APIs originate in just five countries. When production failures or logistical bottlenecks occur there, standard medicines – including antibiotics and antihypertensives – vanish across Europe.
What is the Critical Medicines Act?
The CMA is proposed EU legislation designed to boost production of critical APIs and medicines within Europe. It provides for fast-track approvals for strategic projects, EU funding, and a continent-wide monitoring system for supply shortages. A political agreement is expected in 2026.
Are pharmaceutical companies in Germany required to stockpile medicines?
Yes. Since 2024, companies with rebate agreements must hold a three-month stockpile of covered medicines. This measure cushions short-term supply disruptions but does not address the structural dependency on Asian API suppliers.
Which funding instruments support pharmaceutical manufacturing in Europe?
The Critical Medicines Act foresees support via several EU funding streams: STEP (Strategic Technologies for Europe Platform), EU4Health, InvestEU, and Horizon Europe. Strategic projects will also benefit from accelerated authorisation procedures.
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