Europe – EU agencies clarify pharmacovigilance expectations amid COVID-19

In an update to their joint questions and answers document on regulatory expectations for medicinal products amid the coronavirus disease (COVID-19) pandemic, the European Medicines Agency (EMA), European Commission and Heads of Medicines Agencies (HMA) expand on their expectations for pharmacovigilance.
 
The updated document features three new questions related to pharmacovigilance, covering topics from corrective and preventive actions management to pharmacovigilance system audits and on-site pharmacovigilance inspections. (RELATED: EMA Q&A explains regulatory expectations for drugs during the pandemicRegulatory Focus 10 April 2020; EMA updates on regulatory expectations amid COVID-19Regulatory Focus 20 April 2020).
 
The first new provision gives marketing authorization holders (MAHs) some leeway to deviate from their management of corrective and preventive actions (CAPAs) related to pharmacovigilance during the pandemic.
 
“During the pandemic situation MAHs might activate business continuity plans and prioritise activities. Therefore, in case MAHs are unable to continue standard management of corrective and preventive actions, for justified reasons relating to the pandemic, they should temporarily prioritise the deviations,” using a risk-based approach…