(P-596) Insights from a Review of Publicly Available Information on Post Authorisation Safety Studies (PASS)

Background: Information on safety concerns and Post Authorisation Safety Studies (PASS) included in risk management plans (RMPs) for new medicinal products is available in different public sources.

Objectives: The aim of this study was to assess whether the information from different public sources can be used to gain insights into safety concerns and PASS for medicinal products.

Methods: European Public Assessment Reports (EPARs) of all products approved during 2017 and 2018 were reviewed to extract the following information: safety concerns, additional risk minimisation measures (aRMMs) and/or PASS. The EU PAS register and PRAC Meeting Minutes (from inception to Q1 2020) were also searched for information on PASS described in the EPARs.

Results: EPARs of 183 different medicinal products were identified: 149 unique active substances and 34 generics/biosimilars. Most substances were from ATC class antineoplastic and immunomodulating agents (34%), followed by anti-infectives for systemic use (15%) and alimentary tract and metabolism drugs (14%). Among the 2415 safety concerns for the products, 36% were to be investigated in a PASS, 11% had aRMMs, and 6% had both PASS and aRMMs. More safety concerns of alimentary tract products were investigated in a PASS (45%), followed by those from the blood and blood forming organs class (42%) and antineoplastics (41%). Only 15% of the anti-infectives’s safety concerns had a PASS. Most of the PASS were clinical studies (95%). Approximately half were already ongoing, of which 61% were interventional. Of planned PASS, 78% were non-interventional studies (NIS). Among all NIS, the vast majority (88%) were category 3 (required). One third of NIS PASS were registered in the EU PAS; less than 10% of those had a protocol available. Registration was higher among category 1 & 2 NIS PASS (56%). Notes were found in PRAC meeting minutes for 37% of NIS PASS with a higher proportion among the category 1-2 subgroup (75%).

Conclusions: It is possible, but not straightforward, to identify safety concerns and PASS for medicinal products using public sources. Most planned PASS are NIS. Despite mandatory registration for categories 1 & 2 studies, only little more than half actually were registered, and few protocols for any studies were included in the EU PAS Register. Registration and publication of protocols should be increased for all categories of studies. Additionally, it would improve transparency if studies in the EPAR were given a unique number which could then be included in other EMA public documents and the EU PAS register.