Are you a small or medium-sized enterprise (SME) established in the European Union (EU)/ European Economic Area (EEA)? If so the European Medicines Agency (EMA) provides incentives and support for SMEs developing medicines for humans.
Criteria
The criteria are:
| Category | Head count | Annual turnover | Or balance-sheet total |
| Medium-sized | < 250 | ≤ € 50 m | ≤ € 43 m |
| Small | < 50 | ≤ € 10 m | ≤ € 10 m |
| Micro | < 10 | ≤ € 2 m | ≤ € 2 m |
The detailed criteria is set out in Commission Recommendation 2003/361/EC
Interesting fact: SMEs developed nearly 20% of all human medicines recommended for authorisation in 2020; half of these target a rare disease.
Support
The support includes financial advantages such as fee exemptions and reductions for pre- and post-authorisation regulatory procedures, including scientific advice, inspections and pharmacovigilance. For detailed information on financial guidance see: https://www.ema.europa.eu/en/human-regulatory/overview/support-smes/financial-advantages-sme-status
EMA’s SME office offers guidance through advising, directing and liaising SMEs with relevant scientific and regulatory contact points within EMA; this can be on regulations, administrative requirements procedures and clinical data publication.
You can also receive translation assistance upon grant of an initial marketing authorisation.
Above is just some of the support available for more information take a look at: https://www.ema.europa.eu/en/human-regulatory/overview/support-smes
Interesting fact: Between 2016 and 2020 the success rate for SME marketing authorisation applications for human medicines more than doubled, reaching 89% in 2020.
Once registered SMEs are included in an online SME register. This register is a public source of information on EU and EEA-based SMEs involved in manufacturing, development or marketing of medicines for human or veterinary use.
Interesting fact: Between 2016 and 2020 more that 4 in 10 medicines selected for EMA’s PRIME: priority medicines scheme were from SMEs.
Applying for SME status
Fusion Pharma can support you in your application for SME status in the EU, We offer a complimentary SME service; use our SME eligibility tool available on our website to check if you qualify.
Alternatively you can email us at hello@fusion-pharma-limited.com or phone us on +44 (0) 203 1379 799.
If you are looking for SME status in the UK, take a look at my UK blog.
While the information in this article is considered to be true and correct at the date of publication, changes in guidance and/or experience may impact on the accuracy of the information. Please refer to the relevant guidance for the latest information.