Benefit from EMA’s Innovation Support and Incentives for Small Biotech and Pharma Businesses
The European Medicines Agency (EMA) supports micro-, small- and medium-sized enterprises (SMEs) that develop human or veterinary medicinal products to promote innovation and the development of new medicines. To achieve this, incentives are provided to help SMEs overcome the main financial and administrative hurdles associated with pre-marketing procedures, particularly scientific advice, marketing authorization applications, and inspection procedures. The initiative also introduced incentives for post-authorization procedures.
THE INCENTIVES - WHAT ARE THE BENEFITS FOR SMEs?
Once the SME status has been granted, companies are eligible for the following incentives provided by EMA:
Regulatory, administrative, and procedural assistance from the Agency’s SME office including SME briefing meetings;
Fee incentives, which are further detailed in Exhibit 1;
Certification of quality/ non-clinical data for advanced therapy medicinal products (ATMPs) intended for human use;
Translations of the product information documents submitted in the application for marketing authorization;
Waiver of the MedDRA licensing fee when registering with EudraVigilance. This is only available for micro- or small enterprises, not for medium-sized enterprises;
Inclusion in the SME public register.
Especially, fee reductions can be significant incentives for SMEs. For example: for a multidisciplinary EMA scientific advice procedure, SMEs pay a fee of around 8,000 euros instead of 80,000 euros for non-SMEs. To benefit from any fee incentives, the SME status has to be assigned by EMA’s SME Office before a regulatory submission. Therefore, it is recommended to consider registration as an SME early during the development.
EXHIBIT 1 | Fee incentives and financial benefits provided by EMA for SMEs.
THE CRITERIA – IS YOUR COMPANY AN SME?
The main criteria determining whether an enterprise is an SME are:
The company must be established in the European Economic Area (EEA);
Staff headcount of less than 250 employees;
Either an annual turnover of not more than 50 million Euro or an annual balance sheet total of not more than 43 million euro.
The above-defined thresholds apply to individual firms only. If a firm is part of a larger group, the headcount and financial data of the linked enterprises or partners will be considered.
NON-EEA SMEs - CAN COMPANIES OUTSIDE OF THE EU BENEFIT?
Yes, non-EEA companies, i.e. companies outside of the EU, can register as SMEs and take advantage of the SME incentives under one of the following conditions:
Companies have established a subsidiary in the EEA
Indirectly benefit from the SME incentives through an EU-established SME regulatory consultancy.
Therefore, SMEs that are based outside of the EU (e.g. Switzerland, USA, India, or China) can also benefit from EMA’s SME incentives. In the context of Brexit, UK-based SMEs need to submit a new SME application under the options for non-EEA SMEs above.
THE PROCESS - WHAT IS THE SME OFFICE? HOW TO OBTAIN SME STATUS?
The SME Office has been established at EMA to offer assistance to SMEs including providing contact with relevant scientific and regulatory staff within the Agency to help address any questions early during product development.
For registration as an SME, companies need to complete the form “Declaration on the qualification of an enterprise as micro-, small or medium-sized enterprise (SME)” and submit it to the SME Office. Annual accounts, ownership information, and proof of establishment in the EEA should be included as additional documentation.
MF BIOTECH is registered as an SME at EMA and can support your SME registration, including companies based outside of the EU.
Check if SME requirements are met
Assistance during the SME registration process
Preparation of the application package
Maintenance of the SME status