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:

• Veterinary Regulation: the document has been fully revised to align with the veterinary regulation
• Clinical Trials Regulation (new section 4.4): provides an overview of the clinical trial regulation and Clinical Trials Information System (CTIS)
• Medical Devices Regulation (new section 4.8): offers insights into the medical devices regulation for human medicines

Other important new sections/subsections include:

• IT…