For non-EU small and medium-sized pharmaceutical enterprises, establishing a foothold in the European market is essential. Leveraging the European Medicines Agency’s (EMA) Small and Medium-Sized Enterprise (SME) status can offer significant regulatory and financial benefits. However, non-EU companies must navigate the process through an EU-registered third party, ideally a seasoned SME regulatory consultancy.

Advantages of Working with a Regulatory Consultant for SME Status

A regulatory consultancy specializing in SME status serves as the primary point of contact for the EMA, both during the application phase and while maintaining the designation. A skilled consultancy assists clients throughout the application process, represents them in EMA meetings, and manages submission and renewal processes annually. Importantly, the consultancy provides timely reminders to ensure the SME designation remains current and in good standing.

Requirements for Collaborating with a Regulatory Consultancy

To proceed with an SME regulatory consultancy, companies must supply all information necessary for the SME application. This includes access to annual accounts, organizational ownership structures, and any documentation required in the application form.

The choice of consultancy should be approached strategically. For instance, if one consultancy handles scientific advisory meetings with regulators and another manages the SME status, companies may face challenges in accessing fee incentives, as only the consultancy overseeing the SME designation can secure these on the client’s behalf. This is also true for procedures like orphan drug designation, where unified oversight by a single consultancy is essential to access incentives.

Expectations from Your SME Regulatory Consultancy

While numerous consultancies now provide SME status services, choosing a consultancy with extensive experience in SME applications can streamline the process significantly. Experienced consultancies can anticipate regulatory requirements and help avoid common issues, such as incomplete account information or ineligible headcounts, which can cause delays.

When all required documentation is provided on time and without errors, companies can often secure SME designation within a week. However, companies with unclear ownership structures or unanticipated shareholder arrangements may face delays of three to four months.

The Value of Specialized Consultancy

SME status is aimed specifically at smaller companies, so it’s crucial that the consultancy selected understands and prioritizes the unique needs of small to medium enterprises. Large consultancy firms may offer SME services, but applications may be deprioritized among their broader client commitments.

Smaller consultancies tend to be more engaged and selective in communicating relevant EMA updates and opportunities tailored to the client’s focus area. For instance, a consultancy knowledgeable about the client’s area, such as innovative human medicines, will avoid forwarding irrelevant information, such as training programs for veterinary medicine.

Relevant updates ensure that companies are aware of beneficial training programs and stay informed about EMA regulatory changes, incentives, and requirements. This tailored approach ultimately enhances the value of SME designation, helping companies succeed in the EU regulatory landscape.