Here is a roundup of the impact of the current pandemic on global pharmacovigilance (PV) practices in both clinical trials and post-marketing.
Various National Competent Authorities have published guidance documents relating to the conduct of clinical trials and Pharmacovigilance, as well as post-marketing regulatory compliance during this Public Health Emergency.
Challenges may arise from quarantines, site closures, travel limitations, interruptions to the supply chain for the investigational product, or if site personnel or trial subjects become infected.
The European Medicines Agency (EMA) guidance for the management of clinical trials states that sponsors should remain compliant with safety reporting and investigators should continue to collect adverse events from study subjects. This may need to be conducted through alternative methods when physical visits are not possible, such as telephone.
Although the EU guidance doesn’t mention any flexibilities regarding safety reporting timelines, the Medicines and Healthcare products Regulatory Agency (MHRA) guidelines convey that timelines will not always be met, however every effort should be made to prioritise submission of suspected unexpected serious adverse reactions (SUSARs) on time.
The French Agency (ANSM) guidance provides some flexibility regarding safety reporting compliance. SUSARs should still be submitted according to existing requirements, but they will allow a two month delay for Development Safety Update Reports (DSUR).
A US Food and Drug Administration (FDA) guidance on conducting clinical trials during COVID-19 recommends that sponsors evaluate safety assessment methods to ensure the safety of trial participants and avoid unnecessary contact.
The FDA have published an updated guidance on post-marketing adverse event reporting for medical products and dietary supplements during a pandemic. Compliance should be maintained as much as possible, however the FDA accepts that flexibility will be required in adverse event reporting responsibilities to ensure business continuity. Health Canada’s Notice on Mandatory Reporting Requirement also aligns with the FDA views.
The MHRA has included a new section on PV in its guidance on regulatory flexibility during COVID-19. This encapsulates incident case safety reporting (ICSR), risk minimisation measures to ease the burden on healthcare professionals (HCP), postponement of certain PV activities, and safety variations.
The EMA has issued detailed guidance on ICSR processing in the context of COVID-19. Marketing authorisation holders (MAH) should prioritise the submission of ICSRs in situations where they are unable to continue standard reporting operations. MAHs should first prioritise the submission of serious ICSRs for products used to treat or prevent COVID-19, before submitting other serious ICSRs. Beyond serious ICSRs, EMA says MAHs should prioritize non-serious ICSRs for products used in relation to COVID-19 before submitting other non-serious ICSRs. EMA says it is “essential that MAHs report all serious ICSRs within the 15 days set out in Directive 2001/83/EC,” and that “MAHs who are forced to prioritise ICSRs should make a note in their pharmacovigilance master file regarding the practice”.
Check back to the Regulis news page frequently for the latest updates on the changes to PV in light of the current pandemic.