EU agencies clarify PV expectations during pandemic

A joint question and answer (Q&A) document features three new questions related to pharmacovigilance (PV).

The European Medicines Agency (EMA), European Commission and Heads of Medicines Agencies (HMA) released the guidelines in April to explain regulatory expectations for medicinal products during COVID-19.

The three new questions addressed cover corrective and preventive actions management, PV system audits and on-site PV inspections:

  • Is there any impact on corrective and preventive actions management under the PV provisions?
  • Is there any flexibility in the planning and conduct of PV system audits?
  • Which measures will be taken in light of difficulties to conduct on-site PV inspections during the COVID-19 pandemic?

The document was also updated with an explanation as to the circumstances in which the validity of good manufacturing practice (GMP) certificates may be extended to clarify that, as with sites located in the European Economic Area (EEA), sites located outside the EEA cannot receive an automatic extension for changes in the scope of the GMP certificate.

To view the answers to the new questions, and for more information, click here.