Romania changes its approach to clinical trials approval!
After years of decline in the number of new approvals, Romanian authorities are finally making the turn, thanks to the efforts of the association representing clinical research organisations in Rumania. In March this year Dr. Alina Musetescu was appointed as the new Head of Clinical Trial Department and wrote the following on her LinkedIn profile:
"Living in a country where clinical trials have experienced a real decline in recent years, I have been honoured to accept the proposal to work for a limited time in the Department of Clinical Studies. I do not know if I can move the things on, but at least I will do my best to try! Let's don't judge the past but do improve the present and the future!"
Within a few months, the Romanian Regulatory Authority proudly announced, on their web site (https://www.anm.ro/anunt-important-03-06-2019/), that they are in the process of eliminating the delays in clinical trial evaluation and approval timelines. They further communicated that clinical trial approvals had experienced a 44% increase in the period Feb-May 2019, compared to the same period in 2018 (with 78% increase in May 2019 only).
Altiora will follow the developments in Romania and will keep you posted.