For any non-EU small and medium-sized pharmaceutical company, having a gateway to the European market is crucial. Those companies seeking to take advantage of the European Medicines Agency’s (EMA) SME status will need to work through an EU registered third party, ideally an experienced SME regulatory consultancy.
The benefit of having a consultancy for the SME status is they act as both the contact point during the application process and while you hold the designation. An experienced consultancy can support potential SMEs through the application process, attend meetings on your behalf and coordinate submissions and the annual renewal of applications. An experienced consultancy will also send reminders to you that renewal with the SME office is due, so your status doesn’t lapse.
What is required to work with a consultancy?
When working through an SME regulatory consultancy, companies must provide all information needed to complete the SME application. That means giving the consultancy access to all relevant information, including annual accounts, the chart of your ownership structure and any other information requested in the SME application form.
Your choice of SME consultancy should be considered from a strategic perspective. For example, if you are working with one consultancy to assist you with scientific advice meetings with the regulators and another for your SME status, you are likely to run into issues with accessing fee incentives. That’s because only the consultancy managing the SME status can access those incentives on your behalf.
The same is true for orphan drug designation or other pre-authorisation procedures, where the entire process would need to be handled by one consultancy in order to access the incentives.
What should you expect of your SME consultancy?
While a growing number of consultancies offer SME status services, it’s important to weigh your decision carefully. First, you want your consultancy to have experience with the SME process, preferably having done many SME applications. That helps to reduce the back-and-forth with the EMA because your consultancy will know exactly what information the regulatory authorities are looking for.
A consultancy that doesn’t have much SME experience may miss problems, such as if the headcount is too high for SME status, or if the account information isn’t complete. Inevitably, if too much information is missing or if the agency has to ask too many questions, the process will be delayed.
Typically, if there are no questions from the EMA and the company has supplied everything on time, it’s a pretty straightforward process. Certainly, in our experience, we have had companies get their designation within a week. If the company isn’t sure of their structure, or they weren’t aware of majority shareholders, the process can take longer, potentially three or four months.
Think small, not big
The SME Status is about designation as a small or medium-sized company. You should expect your consultancy to understand and priortise this. With large businesses that offer some consultancy, the application process may be lost or just not be a priority.
Smaller consultancies are also more involved in staying on top of everything to do with these types of programmes. Rather than blindly forwarding EMA training events and newsletters to the small business, you would want your consultancy to be sending you relevant information based on what is appropriate to your organisation. For example, a company developing innovative medicines for human use won’t be interested in training programmes for veterinary medicines, or a company focused on stem cell development won’t want to see everything about small molecule development.
Getting pertinent information can ensure you know about training programmes that will be beneficial to your organization, and help you stay on top of EMA changes, incentives and requirements.
“You want your consultancy to have experience with the SME process, preferably having done many SME applications.”