Support to SMEs

The European Medicines Agency (EMA) provides incentives and support for micro, small and medium-sized enterprises (SMEs) that are developing medicines for human or veterinary use, in order to promote innovation and the development of new medicines.

This support is open to all companies and enterprises that have SME status assigned by EMA.

The SME office was set up by Commission Regulation (EC) No 2049/2005 (the SME Regulation). It provides advice, guidance and assistance to SMEs who want to develop and market medicines in the European Union (EU) and the European Economic Area (EEA).

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.
 

EMA's SME office offers guidance through advising, directing and liaising SMEs with relevant scientific and regulatory contact points within EMA. By helping smaller companies find their way through the centralised authorisation procedure, EMA requirements and other procedures, the SME office facilitates medicines development and applications for marketing authorisation.

Registered SMEs can:

• contact the SME office for questions about regulations, administrative requirements or procedures: by phone +31(0)88 781 8787 or email.
• request a briefing meeting 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;
• receive translation assistance for the product information into all official EU languages for the purpose of granting an initial marketing authorisation;
• receive guidance on clinical data publication;
• stay up to date with SME newsletters;
• participate in training events;
• receive support with looking for academic partners in the paediatric-medicine field (European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA)).

Detailed information on the financial advantages available for SMEs and on applying for SME status is available below:

• Financial advantages of SME status
• ​​​​​​Applying for SME status

EMA recommends SMEs to consult EMA's SME user guide. The 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 a marketing authorisation in the European Union (EU)/ European Economic Area (EEA).

In order to receive support from EMA as an SME, enterprises should apply for SME status with the SME office. To be eligible, companies must be established in the European Union (EU)/ European Economic Area (EEA) and meet the definition of an SME (SME criteria). 

The support for SMEs includes fee exemptions and reductions for pre- and post-authorisation regulatory procedures, including scientific advice, inspections and pharmacovigilance.

After an SME status has been granted, the company will be included in EMA's public SME register. One of the objectives of this online register is to facilitate and promote interaction, partnering and networking between SMEs.

Details on the SME criteria and how to apply:

• Applying for SME status
• SME register

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

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

The translation process can begin as soon as the CHMP/CVMP has issued a positive opinion on the medicine's authorisation, provided that the applicant has a valid SME status at this time. 

During the evaluation of a marketing authorisation application, EMA sends procedural details on the translation assistance 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.

The SME office regularly produces newsletters which highlight:

• news and guidance of relevance to SMEs and their stakeholders;
• developments in EU regulations and regulatory environment;
• events and training opportunities. 

The three most recent issues are available below:

Previous issues are available via:

• Newsletters

The SME office organises events to inform, engage or train SMEs on relevant topics.

• Find events and training opportunities, including related reports and presentations