The EU PAS Register gives an affluence of information on the safety and value of authorized medicines. It is a cooperatively available podium with information on post authorization research in medicines already marketed in Europe and comprises study etiquettes, study results, related publications and other appropriate and significant information.
The 1,000th study has been uploaded in the European Union (EU) electronic Register of Post-Authorization Studies (EU PAS Register).
The information in the EU PAS Register reduces publication bias[i] (A type of bias that occurs when the outcome of a study influences the decision whether to publish or otherwise allocate it) through improved transparency of medicines research, improves the quality of post-authorization studies by enabling peer-review of protocols and results, simplifies association among stakeholders, and ensures passivity with EU pharmacovigilance legislation necessities.
The majority of studies in the EU PAS register are non-interventional, meaning the assignment of the patient to a therapeutic strategy is not decided in advance by a trial protocol but falls within existing medical practice [ii] (The assignment of the patient to a particular therapeutic strategy in a clinical trial is decided in advance and does not fall within normal clinical practice) and the treatment of the medicine is clearly separated from the decision to include the patient in the study.
These studies complement the evidence generated through the clinical development programme supporting the initial marketing consents of a medicine. They provide valuable perception into the use of a medicine in normal clinical practice and are essential in fully characterizing the safety and effectiveness profile once it is marketed and throughout its life span.
Regulators across the EU boost the registration of all non-interventional post-authorizations studies, regardless of who initiates, manages or finances them. Companies must register all non-interventional post-authorizations safety studies (PASS) forced by regulators. They are stimulated to register PASS requested to obtain further information on a medicine’s safety, or to measure the effectiveness of risk-management measures.
The EU PAS Register was developed through the European Network of Centre for Pharmacoepidemiology and Pharmacovigilance