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).
EMA recommends SMEs to consult a dedicated user guide and annex, published below.
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).
The latest version, published in January 2024, features new and revised sections on veterinary medicines, clinical trials and medical devices.
Its annex refers to existing national provisions for SMEs, applicable to the pharmaceutical sector.
Read SME user guide
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:
Detailed information on the financial advantages available for SMEs and on applying for SME status is available below:
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:
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.
Small and Medium-sized Enterprises (SMEs) Highlights, published four times a year, provides key updates to SMEs on the European regulatory environment.
Issues from February 2024 (Issue 61) onwards are available at the link below:
Previous issues are available on EMA's website in PDF format:
Use the link below to receive Small and Medium-sized Enterprises (SMEs) Highlights by email:
The SME office organises events to inform, engage or train SMEs on relevant topics.