Jasmina Savic MSc, RAC | JS Regulatory
On 16 June 2014 a new Clinical Trial Regulation entered into force in Europe. It will apply no earlier than 28 May 2016.
The new regulation presents a major step forward in harmonizing clinical trial assessment process in the EU. For years, Europe was criticized for having too complicated, non-harmonized, nationally driven procedures for clinical trial assessment which often resulted in timely unpredictable and divergent assessment conclusions. Sponsors were faced with numerous country-specific protocol amendments as result of different opinions of one-country’s Competent Authority and Ethics Committee compared to opinions of other EU countries or even different opinions of Ethics Committee compared to national Competent Authority of the same country. In any case, Sponsors could expect any combination of decisions and close follow up by national experts was necessary.