Search

Filter by

Document type
Last updated
First published

Search results (65)


The European Medicines Agency (EMA) offers full or partial fee exemptions for its pre- and post-authorisation regulatory procedures for micro, small and medium-sized enterprises (SMEs) who want to develop and market medicines in the European Union (EU) and the European Economic Area (EEA).

HumanVeterinaryRegulatory and procedural guidanceSME

The main objective of the small and medium-sized enterprises (SME) Regulation (Commission Regulation (EC) No 2049/2005) is to provide financial and administrative assistance to these enterprises through the SME office of the European Medicines Agency (EMA). It also aims to address the needs of smaller companies in the pharmaceutical sector.

HumanRegulatory and procedural guidanceSME

The European Medicines Agency (EMA) publishes newsletters to provide updates on various topics to patients, healthcare professionals and the pharmaceutical industry.

HumanVeterinaryData on medicinesPharmacovigilanceSME
EventHumanMedicinesSME

The European Medicines Agency (EMA) has released a major revision of its user guide for micro, small, and medium-sized enterprises (SMEs) in the pharmaceutical sector.

NewsHumanVeterinaryMedicinesSME

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.

HumanVeterinaryRegulatory and procedural guidanceSME

The European Medicines Agency's Committee for Advanced Therapies (CAT) provides a certification procedure for advanced therapy medicinal products (ATMPs) under development by micro-, small- and medium-sized enterprises (SMEs). This is an opportunity for SMEs to get an assessment of the data they have generated and check that they are on the right...

HumanAdvanced therapiesRegulatory and procedural guidanceResearch and developmentSME