Follow-up activities after Pharmacovigilance Inspections

EMA´s Pharmacovigilance Inspectors Working Group adopted a new guideline on the follow-up activities of pharmacovigilance inspections (effective since May 1, 2020). It applies to the follow-up of pharmacovigilance inspections of Marketing Authorization Holders (MAHs) with centrally authorized products (CAPs), nationally authorized products (NAPs), products authorized via the mutual recognition or decentralized procedure (MRP, DCP). The new guideline replaces the EMA document “Union procedure on the management of pharmacovigilance inspection findings which may impact the robustness of the benefit-risk profile of the concerned medicinal products”.

Pharmacovigilance Inspections

The competent authority

  • may inspect the premises, records, documents and pharmacovigilance (PV) system master file (PSMF) of the MAH or any contracted firms to perform the respective PV activities,
  • is required to report on whether the MAH complies with the requirements and the content of those reports shall be communicated to the inspected entity,
  • shall bring any deficiency to the attention of the MAH and give him the opportunity to submit comments,
  • shall inform the other Member States, the Agency and the Commission.

Follow-up of pharmacovigilance inspections and responsibilities of the parties involved

Any non-compliance identified should be rectified by the MAH in a timely manner. The Agency´s procedure includes the following steps:

  • requesting a written corrective and preventive action (CAPA) plan from the MAH,
  • CAPA plan review and approval by the inspectors,
  • routine interaction within and between Members States and the EMA,
  • actions to be taken following the identification of inspection findings,
  • and reinspection planning.

Post-inspection actions may also involve assessors in the Member States, the Agency and other committees such as the Pharmacovigilance Risk Assessment Committee (PRAC).

According to the Agency, some PV inspections will require significant follow-up and management due to the nature of the findings identified. In addition, the Commission is empowered to impose financial penalties on the MAHs.

More detailed information can be found in "Union procedure on the follow-up of pharmacovigilance inspections" on the EMA website: Pharmacovigilance inspection procedures: human.

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