26 January 2024 – The European Medicines Agency (EMA) has released a major revision of the SME user guide in the pharmaceutical sector. 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.

For more information, see here.