Periodic safety reporting

The major goal of pharmacovigilance is to ensure continuous monitoring of the safety profile of medicinal products. To verify that MAHs live up to these obligations, Competent Authorities require the submission of periodic safety reports wherein an overview of the safety findings is presented. For products in clinical trials, FDA requires submission of Investigational New Drug (IND) reports, whereas EMA requests annual Developmental Safety Update Reports (DSURs) and other regions may require Annual Safety Reports (ASRs). For products that have received marketing authorisation, PADERs (Periodic Adverse Drug Experience Report) or Periodic Safety Update Reports (PSURs) are required, also referred to as Periodic Benefit Risk Evaluation Reports (PBRERs). Addenda to the Clinical Overview (AddCO) are generally submitted during a renewal, to present the Competent Authorities with a short overview of the information presented in the PSURs submitted during the marketing authorisation period including the period not yet covered by a PSUR.

DADA has templates available for all these reports and in cooperation with you we can write and submit any of these reports on your behalf. In addition, DADA can conduct a literature review following a medical question to prepare a medical safety evaluation for your product outside of the scope of these periodic reports, for example as part of signal evaluation activities. DADA is continuously monitoring communications regarding the new pharmacovigilance legislation and actively participates in review of draft consultation papers to stay up to date on the requirements for periodic safety reports.