Trial characteristic Definition
Types of file It contains public assessment reports, scientific discussions, and product information, all of which were reviewed and evaluated manually to determine whether they incorporated adaptive design for relative confirmatory or exploratory trials.
Year of authorization It derived from the date when medical products were granted with the first marketing authorization.
Orphan designation It determines whether the medince is designated as an orphan drug that referred to treatments for rare diseases.
Pivotal status It determines whether an adaptive design is scheduled into a confirmatory trial.
Accelerated assessment status It defines whether the assessment is a rapid assessment of medicines in the centralised procedure with shorter period of assessment, which usually takes 150 evaluation days, rather than 210 days.
AM status It defines whether the medicine is being monitored closely by regulatory authorities and surveilled more intensively than others.
CMA Medicines granted CMA usually correspond to the interest of public health but with less comprehensive clinical data than generally required
PASS/PAES It is a study that is carried out after a medicine has been authorized to obtain further information relevant to the safety/efficacy of it.
NAS status It defines whether the medicine is a chemical substance not previously authorized as medicinal product in European Union.
SOC It is the highest level of the Medical Dictionary for Regulatory Activities (MedDRA) 1 hierarchy, which was distinguished by the anatomical or physiological system, etiology (disease origin), or purpose.
Antitumor status It depends on whether indications were for cancer diagnosis or treatment.
Study progression It is derived from the progression of clinical trials at the time when products were approved, including completed and ongoing trials.