Small and Medium-sized Enterprise (SME) status
As a registered SME ourselves, we can support your regulatory submissions to the European Medicines Agency by acting as the SME on your behalf.
Small and medium-sized enterprises (SMEs) are integral to drug development.
Often, they sponsor the development of innovative medicines (particularly cell and gene therapies), medicines for rare diseases, and medicines in underrepresented therapeutic areas.
However, SMEs often come up against specific challenges, particularly financial challenges. The drug development process includes several regulatory milestones, and missing these milestones may negatively impact the overall outcome of an SME’s MAA.
As well as financial constraints, SMEs may have limited resources to commit to developing a detailed understanding of country-specific regulatory processes; have limited access to subject matter experts, and face competition with large and intermediate-sized enterprises.
Applying for SME status involves three steps:
- Define the type of SME you are.
- Apply to the EMA’s SME office.
- Maintain your SME status.
Applying to become a registered SME with the EMA is straightforward if you have all of your company information ready to go.
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How to apply for Small and Medium-Sized Enterprise (SME) status with the EMA
This article outlines who qualifies for SME status, how to apply, and what support is available once approved.
Subscribe to our Monthly Regulatory Intelligence Scan
Our monthly newsletter gives you the latest European and UK regulatory intelligence. We bring you new and interesting approvals; fast-to-market applications, orphan designations; paediatric applications and therapy area-specific news.
You can unsubscribe at any time from the link in the newsletter footer. Read our Privacy Policy here.
FAQs
What are the incentives for Small and medium-sized enterprises?
- Financial fee incentives,
- regulatory assistance services,
- SME briefing meetings,
- translations assistance,
- training events,
- guidance on clinical data publication,
- support with the PRIority Medicines (PRIME) scheme,
- a dedicated SME office to respond to regulatory, procedural and administrative questions, and
- Advanced Therapy Medicinal Products (ATMP) incentives (certification).
What are the fee incentives for Small and medium-sized enterprises?
- 90% fee reduction for scientific advice for non-orphan medicinal products
- 100% fee reduction for protocol assistance (scientific advice on orphan medicinal products)
- Fee deferral until the marketing authorisation application outcome for non-orphan medicinal products
- 100% fee reduction for initial marketing authorisation applications for orphan products
- 100% fee reduction for the post-authorisation activities for micro-sized enterprises for non-orphan products
- 40% fee reduction for the post-authorisation activities for small or medium-sized enterprises for non-orphan products
- 100% fee reduction for the post-authorisation activities for orphan products
What are the benefits of having a regulatory affairs consultancy guide our SME application and development programme?
Some regulatory affairs consultancies are registered SMEs. This means they can support your regulatory submissions to the European Medicines Agency (EMA) by acting as the SME on your behalf. Regulatory affairs companies have the experience navigating regulatory agency interactions and regulatory submissions in Europe and can confidently guide you through your regulatory milestones, including;
- scientific advice interactions,
- paediatric development
- orphan designation and maintenance, and
- the marketing authorisation application itself.