[Programas de apoyo a la I+D+i]
De interés para:
Para el sector salud
Resumen:
The European Medicines Agency (EMA) is delighted to announce the release of the updated SME user guide.
The revised user guide offers comprehensive information on the EU legislative framework for medicines, outlining requirements for the development and authorisation of medicines for human and veterinary use. It follows the chronological stages of medicine development, and has become a reference source of information for SME and academic developers, supporting them to navigate the system of medicine regulation in the EU. The new release incorporates significant updates to reflect major changes in the EU’s legal and regulatory framework for human and veterinary medicines.
In addition, the annex to the user guide with national provisions for SMEs applicable to the pharmaceutical sector was revised.
