On 28 May 2026, the European Medicines Agency (EMA) published a report titled '20 years supporting small and medium enterprises (SMEs) at EMA', reviewing two decades of dedicated assistance to SMEs in the pharmaceutical sector. The report outlines the agency's efforts to reduce regulatory burdens and foster innovation among smaller companies, which often face disproportionate challenges in bringing medicines to market.
The document, produced by EMA's SME Office, details the evolution of support measures since the office's creation in 2006. These include fee reductions, scientific advice, and administrative simplifications. According to the report, over 3,000 SMEs have engaged with EMA's programmes, leading to more than 200 marketing authorisations for human and veterinary medicines. The agency highlights that SMEs now account for a significant share of innovative drug applications, particularly in advanced therapies and orphan medicines.
Policy orientations and trade-offs
promoting innovation by lowering entry barriers, and maintaining rigorous safety and efficacy standards. The report acknowledges that fee waivers and reduced charges—totalling an estimated €150 million in foregone revenue over 20 years—have been essential for SME viability. However, this financial support is partially offset by increased administrative costs for the agency, which must allocate resources to dedicated advisory services. The report also notes that some larger pharmaceutical companies have raised concerns about competitive imbalances, though EMA maintains that SME-specific measures are justified by the higher risk and longer development timelines typical of smaller firms.
Impact on stakeholders
For EU-based SMEs in the biopharmaceutical sector, the report confirms continued access to reduced fees and tailored scientific advice, lowering the cost of regulatory compliance. EU consumers may benefit indirectly from a more diverse pipeline of innovative medicines, particularly for rare diseases. National competent authorities face a moderate increase in coordination workload, as SME applications often require joint assessment with EMA. Larger pharmaceutical companies experience a minor competitive disadvantage due to fee differentials, but the overall market impact is limited given SMEs' niche focus.
Expected institutional follow-up
The report does not propose new legislation but serves as a basis for the European Commission's upcoming review of the SME definition and related incentives under the EU pharmaceutical legislation revision. EMA commits to further digitalisation of SME services and to enhancing outreach in underrepresented EU member states. The agency will also monitor the impact of Brexit, which has reduced the number of UK-based SMEs in its programmes.
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