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 office has the sole remit of providing regulatory, financial and administrative assistance to SMEs who want to develop and market medicines for human or veterinary use in Europe. 

It was set up by Commission Regulation (EC) No 2049/2005 (the SME Regulation) to promote SME-driven innovation and development of new medicines for human and veterinary use.

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 faced by SMEs, such as regulatory burden and access to finance, to help guide EMA's future support activities.  

For more information:

Find out how EMA can help pharmaceutical SMEs by watching this video (2:11 minutes). It is available in English, German, French, Italian, Spanish, Polish and Portuguese.

• Assistance by phone, email and/or teleconference: companies can email the SME office for regulatory, administrative or procedural queries.
• SME briefing meetings to:
  • engage in an early dialogue with a multidisciplinary EMA team;
  • discuss a regulatory strategy for a human or veterinary product development;
  • find out about available procedures, guidance and incentives.
• Fee exemptions and reductions for pre- and post-authorisation regulatory procedures, including scientific advice, inspections and pharmacovigilance (see overview table below). For more information, see Fees payable to the European Medicines Agency.
• Assistance with translations of product information into all official EU languages for the purpose of granting an initial marketing authorisation.
• Inclusion in an online SME register, an important source of information on EU/European Economic Area-based SMEs involved in the manufacture, development or marketing of medicines, promoting 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).
• Training events.

An overview of SME incentives is available in several official EU languages in the leaflet below. The SME office also assists SMEs in official EU languages where applicable.

EMA's SME user guide helps companies navigate the regulatory requirements and 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. 

EMA provides free-of-charge translations of product information in all EU languages for initial EU marketing authorisations (this excludes Icelandic and Norwegian).

EMA provides translation assistance at the time of CHMP/CVMP opinion through the EU Translation Centre (CdT). The national competent authorities verify the quality of translations.

To be eligible, an applicant's SME status must be valid when the process of requesting translations begins.

During the evaluation of a marketing authorisation application, EMA sends procedural details on the translation process to the applicant, who can also contact the SME office for any practical questions.

For access to incentives following mergers, acquisitions or product out-licensing, see sections 2.4.1 and 2.5.3 of the SME user guide. EMA strongly advises companies to contact the SME office to discuss these specific cases.

EMA fee incentives are applied if a company 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 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. EMA strongly advises companies to contact the SME office to discuss access to incentives following a merger and acquisition or product out licensing. For more information, see sections 2.4.1 and 2.5.3 of the guidance in the SME user guide.

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 a company 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.