Croatia ranks among the lowest in Europe for access to new medicines (28%) and has one of the longest delays before patients gain access (around 500 days). AmCham emphasizes that new regulations should simplify and speed up procedures, ensure transparency and clear criteria in line with EU directives, and encourage research and development. In its comments on the draft regulation, AmCham proposes clearer wording of provisions, avoidance of vague terms such as “unacceptably high price,” defined criteria for high-cost medicines and reference groups, longer deadlines for responses, and greater transparency (public disclosure of criteria, decisions, and pricing). The ultimate goal is a faster, more transparent, and fairer system that ensures timely patient access to modern therapies.