EMA revises remote pharmacovigilance inspections guide
The European Medicines Agency (EMA) has refreshed its points to consider document on remote pharmacovigilance inspections during a crisis, such as the current COVID-19 pandemic.The revisions to the document are minor and mostly relate to the preparation phase ahead of a pharmacovigilance inspection when an on-site inspection would not be feasible due to a crisis.
In the revised document, EMA has replaced the term “distant/virtual” with “remote” and has expanded its explanation of a crisis situation that would prevent an on-site inspection from being conducted.
“Under crisis situations (e.g. pandemic, on-site inspections may not be possible due to multiple factors such as difficulties and restrictions related to traveling between and within the borders of countries (including travel warnings/restrictions, border controls, transportation difficulties), restrictions to accessing facilities justified by health hazards and local authorities’ recommendations/orders, as well as additional health risks for inspectors and inspectees,” EMA writes.
One of the biggest changes to the document is the emphasis on the need to determine whether a marketing authorization holder has the technical capabilities to facilitate remote access to their electronic systems and maintain communication with inspectors. EMA notes that “technical nuances” and IT policies will likely pose additional challenges. “For this purpose, an early contact between inspectorate and inspectee is strongly recommended,” the agency writes.
EMA has also revised the sections of the document on documentation and conduct preparation. Several bullets of the documentation preparation section, covering pre-inspection documentation requests and translation, have been removed. The document now says that inspectorates should decide the extent of the documentation to be reviewed in advance and that further requests for documentation are not precluded.
The section on conduct preparation has been completely revised to focus on the importance of video conferencing, IT support and having a detailed inspection agenda. Previously, the section addressed obtaining inspection findings and documentation from past inspections, the process for obtaining documents during the inspection and potential language barriers.
EMA