We’re excited to announce the publication of the EMA SME Office’s 2023 annual report. This document outlines the Office’s functions and their alignment with the needs of European small and medium-sized enterprises (SMEs). Here are some key highlights from 2023:

• Major updates to the SME user guide.
• A 43% increase in SME briefing meetings on regulatory strategies for medicine development.
• Continued uptake of Scientific Advice and Protocol Assistance by SMEs, including on PRIME designated products.
• A 33% increase in the success rate for marketing authorization applications for human medicines.
• Strengthened collaboration with the European Innovation Council and SMEs Executive Agency.
• Significant therapeutic advances achieved with SME-developed medicines, such as Pedmarqsi, Aqumeldi, and Loargys.

Support for SMEs

The Office provides dedicated personnel to assist small and medium enterprises by:

• Responding to regulatory, procedural, and administrative inquiries: 220 instances of direct assistance via phone, email, or teleconference.
• Organizing briefing meetings to discuss regulatory strategies: 10 meetings held on the regulatory strategy of medicinal product development. SMEs receive guidance on navigating EMA’s services, programs, and resources, identifying relevant guidelines for their development, and advice on regulatory strategies for product authorization.

By the end of 2023, 1925 SMEs were registered, comprising 36% micro-sized, 37% small-sized, and 27% medium-sized companies.

Activity and pipelines

As displayed in the following pictures, the majority of registered SMEs is focused on the development of human medicines, followed by service providers and regulatory consultants.