The European Medicines Agency offers a significant and unique benefit to Small and Medium-Sized Enterprises developing medicines for human or veterinary use. The purpose of SME Status is to promote innovation and the development of new medicines.
The SME Regulation, which was established in 2005, led to the creation of the SME office which “provides advice, guidance and assistance to SMEs who want to develop and market medicines in the European Union (EU) and the European Economic Area (EEA).”
Typically, an SME would be a smaller company that perhaps doesn’t have the in-house regulatory support that big companies benefit from. For these small companies, the briefing meetings and the team at the EMA serve as an extension of their team.
Quick access to advice
While obviously not the same as an in-house expert, having SME status does give companies access to advice on a more informal basis. Registered SMEs have access to the SME office through phone or email to request a briefing meeting where they can pose questions of a basic regulatory or administrative nature.
For example, a US-based client was looking for specific guidance on patient-reported outcomes that they weren’t able to find on the EMA website. The SME office was able to quickly come back with recommendations that were helpful as well as advice on how the FDA’s guidance on patient-reported outcomes would apply.
In another example, procedural changes since COVID-19 have meant it is no longer necessary to submit a letter of intent a month before applying for a paediatric investigation plan (PIP). However, since the guidance hadn’t been updated, this change wasn’t clear. The company was simply able to pose a quick question to the SME office, confirming that a letter of intent was no longer required. This saved them time, money and stress.
Reduced fees
One of the most significant benefits of SME status is fee reduction, including for scientific advice, inspection, marketing authorisation and post-authorisation procedures. Many SMEs are developing products for rare diseases and therefore also qualify for orphan drug designation. For those companies, the fees for scientific advice are waived entirely, while, in addition, SMEs are entitled to free translation assistance for product information in all EU languages for their initial marketing authorisations.
A meeting of minds
Another perhaps less-well known benefit is inclusion in the EMA’s SME register. A key advantage of the register is that it promotes interaction between the SMEs, which can be support further partnering and networking between companies.
The register also gives SMEs and their stakeholders access to more information and is also a source of information for other EU institutions, agencies and member states.
What’s holding companies back?
Given the benefits conferred on SMEs, not applying could likely be attributed to lack of awareness about the initiative, since similar schemes are not common elsewhere.
There is also some information that SMEs must share on the declaration form to qualify that some small enterprises with a less defined business structure might find harder to access. This might require input from an external finance team, particularly if account information isn’t publicly available.
Nevertheless, these issues are usually easy to overcome, and the EMA is understanding when they work with global companies.
“One of the most significant benefits of SME status is fee reduction, including for scientific advice, inspection, marketing authorisation and post-authorisation procedures.”