State Institute for Drug Control

30. 1. 2026

Questions and answers – pharmacovigilance

18. 12. 2025

Amendment to the Reimbursement Decree effective as of January 1, 2026

On January 1, 2026, amendment to Decree No 427/2008 Coll., on determination of the amount of costs to be reimbursed for specialised tasks performed by the State Institute for Drug Control and the…

13. 11. 2025

The document Recommendation Paper on Frequent Issues Identified during…

This paper summarises the most common comments and observations raised by Member States and Ethics Committees during the assessment of clinical trial applications. It also provides recommendations…