The European Medicines Agency (EMA) have explained EU wide follow-up procedures for pharmacovigilance (PV) inspections in a 15-page guidance.
According to Article 19 of Regulation (EC) No 726/2004 and Article 111 of Directive 2001/83/EC, the competent authority (CA) of a Member State (MS) where medicinal products are authorised, in cooperation with the EMA, shall ensure that the legal requirements governing medicinal products are complied with by means of inspections. The CA should inspect the premises, records, documents and pharmacovigilance system master file (PSMF) of the marketing authorisation holder (MAH) or any firm employed by the MAH to perform the activities described in Title IX of Directive 2001/83/EC.
After an inspection, the CA is required to report and communicate on whether the MAH complies with the requirements. If it is found that the MAH is not fully compliant with the PV system described in the PSMF, the CA shall bring the deficiencies to the attention of the MAH, EMA, European Commission (EC) and other MS’s. Any non-compliance issues should be addressed by the MAH in a timely manner through the implementation of a corrective and preventive action (CAPA) plan. Some PV inspections will require significant follow-up and management due to the nature of the findings identified.
This guidance document supersedes a 2014 version with the inclusion of new sections and increased detail on the timeframes for post-inspection actions. EMA says that lead inspectors should propose deadlines for responses to inspection findings, which should routinely be 30 working days from receipt of the inspection report. Post-inspection actions may also involve assessors in the Member States, the EMA and other committees such as the Pharmacovigilance Risk Assessment Committee (PRAC). The guidance applies to the follow-up of PV inspections of MAHs with products authorised via the centralised, de-centralised (DCP), mutual recognition (MRP) and national procedures.
The guidance defines the steps to be taken in the follow-up of PV inspections and the responsibilities of all parties involved, including the process for requesting a CAPA plan in writing from the MAH, CAPA plan review and approval by the inspectors. The CAPA plan should be reviewed by the inspector(s) within 30 working days, except in cases where the inspection was requested by the Committee for Medicinal Products for Human Use (CHMP), where a 10 working day review is proposed.
The new sections explain routine communication between Members States, the EMA and regulators outside the EU, and re-inspection planning. After inspections are closed, re-inspections should be timed to assess the implementation of the CAPA plan using a risk-based approach. For critical findings, EMA suggests a re-inspection within 12-18 months, and 24-36 months for significant major findings. For less serious findings, re-inspection should be performed as part of a “routine risk-based inspection programme”.
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