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EMA’s SME Office 2023 Annual Report

  • Post category:Revio News

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.

And regarding SME pipelines and portfolios, 52% of registered SMEs are working with chemical entity-based medicines, 13% with biologics, and 10% with advanced therapy medicinal products.

Research and development support

  • Scientific advice: 154 out of 254 requests (28%) for Scientific Advice were made by SMEs
  • Protocol assistance: 39 out of 119 requests (33%) were from SMEs
  • Scientific advice for PRIME products: 11 out of 38 requests (29%) were from SMEs.
  • Qualification of novel methodologies: 7 out of 18 requests (39%) were from SMEs.
  • Veterinary scientific advice: 6 out of 24 requests (25%) were requested by SMEs.

Marketing authorisation application

In 2023, SMEs pursuing marketing authorization for human medicines had a 75% success rate from 10 initial submissions:

  • 9 positive opinions, including 3 for new active substances and 3 for orphan medicines, with therapeutic areas including neurology and cardiovascular diseases.
  • Significant therapeutic advances with Pedmarqsi, Aqumeldi, and Loargys.
  • 1 negative opinion and 2 withdrawn applications.

For more information and statistics from the SME Office Annual Report 2023, visit:

Additionally, we’ve launched a dedicated webpage for the latest updates, guidance, and developments. Follow us on LinkedIn for more. We hope you find this report insightful and interesting. If you’d like to discuss any of these updates with the REVIO team, please get in touch here.