The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) released a Q&A document on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic. The document is updated continuously and includes Q&As relating to pharmacovigilance.
New Q&As relating to CAPAs, Audits and Inspections
With the third revision (released on July 1, 2020) three new pharmacovigilance (PV) Q&As have been added:
Is there any impact on corrective and preventive actions (CAPAs) management under the pharmacovigilance provisions? In case MAHs are unable to continue standard management of CAPAs for justified reasons relating to the pandemic, they should temporarily prioritize the deviations by applying risk-based approaches. The deviation from the normal processes and procedures should be recorded, limited in time and should be addressed and closed when the circumstances permit.
Is there any flexibility in the planning and conduct of pharmacovigilance system audits? Any adaptation in the planning and conduct ofaudits should be based on a risk-based approach. For cause audits should be prioritized and planned audits should be conducted as soon as possible and without undue delay. Alternative approaches, such as remote audits may need to be considered. Typically this would involve - a mixture of interview sessions (e.g. via telephone or video conferencing) - a document review. Questionnaires alone, without supporting evidence, would not be accepted as audits by the agencies.
Which measures will be taken in light of difficulties to conduct on-site pharmacovigilance inspections during the COVID-19 pandemic? On-site inspections may not be possible due to multiple factors including difficulties and restrictions related to travelling. For PV inspections that are part of inspection programs and cannot be conducted on-site, a remote inspection may be considered, if appropriate and feasible. Decision on “for cause” inspections should be considered on a case-by-case basis by inspectors and concerned assessors. European authorities have previously provided guidance on Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) inspections allowing for the possibility of remote assessments. According to the agencies, remote PV inspections should in principle follow the guidelines that already exist for the conduct of PV inspections. However, they should also take into consideration the limitations imposed by using a remote process. It is essential that the inspectee meets the technical requirements to provide remote access to electronic systems. Prior to the inspection, the inspectee should provide detailed information to allow a feasibility assessment by the inspection team.