Europe – 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…