Supporting SMEs

This content applies to human and veterinary medicines.

The European Medicines Agency (EMA) addresses the unique needs of micro, small and medium-sized enterprises (SMEs) through the SME office. This dedicated interface has the sole remit of providing regulatory, financial and administrative assistance to small pharmaceutical companies.

It was set up by Commission Regulation (EC) No 2049/2005 and promotes innovation and the development of new medicines for human and veterinary use by SMEs.

A report is available from an EMA roundtable with stakeholders on the 15-year anniversary of the SME Regulation in November 2020, where SME stakeholders and regulators discussed the achievements, challenges and opportunities for EU support to SMEs in the pharmaceutical sector.

Findings are also available from the SME Office's 2020 survey of SME experiences with the SME Regulation, EMA's services for SMEs and challenges facing SMEs, such as regulatory burden and access to finance, to help guide EMA's future support activities.  

For more information see:

Administrative, regulatory and financial support is available to companies assigned SME status by EMA, including:

• direct assistance by phone, email, teleconference or through briefing meetings on regulatory aspects of the pharmaceutical legislation. SMEs receive help on how to navigate the array of services available, support in identifying the most relevant guidance, or advice on regulatory strategy for a product development or authorisation;
• fee exemptions and reductions for pre- and post-authorisation regulatory procedures, including scientific advice, inspections and pharmacovigilance (see overview table below);
• assistance with translations of product information into all official European Union (EU) languages for the purpose of granting an initial marketing authorisation;
• inclusion in an online SME register. The register is an important source of information on EU/European Economic Area-based SMEs involved in the manufacturing, development or marketing of medicines and promotes partnering and networking between SMEs;
• guidance on clinical data publication and a free redaction tool license;
• liaison with academic investigators in paediatric-medicine research through the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA);
• workshops and training sessions

To support SMEs and stakeholders across the EU, an overview of the SME incentives is available in EU official languages. The SME office also provides assistance to SMEs in the official EU languages where applicable.

EMA's SME user guide helps enterprises navigate the regulatory requirements and the incentives available throughout a medicine's product lifecycle. It provides an overview of procedures to support research and development activities, and improves understanding of what is needed to obtain marketing authorisation.

• User guide for SMEs

EMA fee incentives are applied if an enterprise has been assigned SME status by the Agency. Companies are advised to register as an SME or renew their status well in advance of a planned regulatory submission to the EMA. Applicants do not need to obtain confirmation of a fee incentive from the Agency. Conditional fee exemptions, where applicable, should be requested at the time of dossier outcome (see below).

Full details of fee determinations, exemptions and payment can be found at Fees payable to the European Medicines Agency.

For access to incentives following a merger and acquisition or product out-licensing, see sections 2.4.1 and 2.5.3 of the user guide for SMEs .

Fee incentives relating to pharmacovigilance activities are applied if an enterprise has been assigned SME status by the Agency, or has submitted a SME declaration or renewal to the Agency. Pharmacovigilance fees will be subject to corrections where an enterprise wrongly claims a fee incentive for pharmacovigilance activities.

Companies are therefore advised to contact the SME office for any question relating to the SME definition prior to formally submitting a SME declaration in relation to pharmacovigilance fees.

For full details on fee determination, payment and fee exemptions and reductions for pharmacovigilance fees, see Pharmacovigilance fees payable to the European Medicines Agency.

For details about fee waivers applicable to MedDRA subscriptions for micro and small sized enterprises, see EudraVigilance system overview and MedDRA's website.