546 Medicines Unavailable:Critical Medicines Act Drives Reshoring

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As of January 2026, 546 medicines were on the BfArM shortage list – ranging from antibiotics to blood pressure medications and salbutamol for asthma patients. 80% of imported pharmaceutical active ingredients come from just five countries, with China alone supplying 45%. The EU is responding with the Critical Medicines Act, aimed at bringing production back to Europe. Here’s what this means for suppliers, logistics providers, and the pharmaceutical mid-market.

546 Shortages: Why Medicines are Missing

The BfArM shortage list documents medicines that manufacturers have reported as unavailable or only partially available. With 546 entries as of January 2026, the list has reached a new record high. For comparison: there were around 400 in 2023 and under 300 in 2019.

The causes are structural, not cyclical. Over the past two decades, the European pharmaceutical industry has systematically shifted API (Active Pharmaceutical Ingredients) production to Asia. The logic was economically sound: lower production costs, less regulatory effort, and faster approval processes. The consequence is now evident: when a factory in Zhejiang fails or a port in Mumbai is congested for weeks, antibiotics are missing from German pharmacies.

Not just niche products are affected. The shortage list includes standard medications: amoxicillin, ibuprofen syrup for children, blood pressure medications like candesartan, and salbutamol inhalers for asthma patients. These are preparations prescribed daily in thousands of doctor’s offices. A shortage of these medicines affects not just individual patients but the basic healthcare provision.

Critical Medicines Act: Europe’s Response to Dependence

The EU has acknowledged the issue and is working on the Critical Medicines Act (CMA). The Commission’s proposal was presented in March 2025, the EU Council took a position in December 2025, and the European Parliament voted in January 2026. A political agreement is expected in the course of 2026, with full implementation starting from 2027.

The CMA relies on three levers to bring pharmaceutical production back to Europe:

1. Strategic Projects: The EU identifies critical active ingredients and medicines with high dependence on third countries. Fast-track approval procedures will be established for their production in Europe – taking months rather than years to obtain operational permits.

2. EU Funding: Several funding pots are available: STEP (Strategic Technologies for Europe Platform), EU4Health, InvestEU, and Horizon Europe. The exact amounts will be determined with the final regulation, but the signals from Brussels are clear: it’s about billions of euros.

3. Monitoring and Early Warning: A European monitoring system is designed to detect supply shortages early and coordinate production capacities. Similar to the HERA mechanism from the COVID pandemic, but permanent and expanded to the entire pharmaceutical market.

„80% of active ingredient imports come from five countries. That’s not diversification, that’s strategic vulnerability.“
– EU Commission, justification for the Critical Medicines Act (March 2025)

Germany: Stockpiling as an Immediate Measure

Independently of the CMA, Germany has already taken action. Since 2024, pharmaceutical companies with discount contracts with health insurance funds have been required to maintain a three-month supply of the relevant medicines. The regulation aims to prevent short-term production failures from immediately leading to supply shortages.

In practice, it has become apparent that the stockpiling requirement helps with short-term disruptions but does not solve the structural problem. If an active ingredient is no longer produced in Europe, a three-month supply is of no use once it’s depleted. Stockpiling shifts the risk in time but does not eliminate it.

For logistics companies and wholesalers, however, the stockpiling requirement has a positive side effect: demand for temperature-controlled pharmaceutical storage and GDP-compliant distribution has surged. Those building or expanding capacities for pharmaceutical logistics are serving a market with guaranteed demand.

Where the opportunities lie for SMEs

The Critical Medicines Act is not just a regulation – it’s a stimulus package for pharmaceutical suppliers in Europe. The explicit promotion of API production, contract manufacturing, and packaging in the EU creates business opportunities in three areas:

API production: Chemical and pharmaceutical SMEs that currently produce for other industries can build production lines for active ingredients with EU funding. Margins in API production are higher than in commodity chemistry, and demand is politically secured by the CMA.

Pharmaceutical logistics: The combination of storage obligations, increasing production volumes in Europe, and GDP requirements drives demand for specialized pharmaceutical logistics. Cold storage, track-and-trace systems, and serialization are growth segments.

Contract manufacturing and packaging: When API production returns to Europe, formulation and packaging follow. Contract Manufacturing Organizations (CMOs) in Germany that are GMP-certified and FDA-audit-capable will become sought-after partners.

For all three areas, the following applies: EU funding is available, fast-track approvals are coming, and political backing is stronger than ever. Companies that build capacity in the next 12 months will enter a market driven by both regulation and demand – a rare combination.

What companies should examine now

The relocation of pharmaceutical production to Europe won’t happen overnight, but the groundwork is being laid now. For SMEs in the chemical, logistics, and packaging industries, a systematic review is worthwhile.

First: Assess your own competencies. Companies that already operate GMP-certified production facilities, master chemical synthesis, or offer GDP-compliant logistics have a head start. The barrier to entry into pharmaceutical supply is lower than many SMEs assume – especially when EU funding reduces investment costs.

Second: Screen for funding opportunities. The CMA funding pots are not yet finally defined, but existing programs (EU4Health, Horizon Europe) are already running. Companies that prepare funding applications now will be in pole position when the CMA is implemented from 2027.

Third: Partner with pharmaceutical companies. Major generic manufacturers are actively seeking European production partners. Companies that form partnerships with originators or generics as CMOs or logistics providers secure long-term supply contracts – significantly minimizing business risk.

The 546 medicines on the BfArM shortage list are not an abstract regulatory problem; they pose a supply risk for millions of patients and simultaneously serve as a market signal: Europe needs its own production capacity and is willing to pay for it. The Critical Medicines Act turns a political statement of intent into a concrete funding program. SMEs that take this seriously will encounter a rare combination of political will, regulatory backing, and real market demand.

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