EMA explains new pharmacovigilance inspection follow-up procedures

In a newly posted guideline that takes effect Friday, the European Medicines Agency (EMA) explains EU-wide follow-up procedures for pharmacovigilance inspections.
 
The 15-page document supersedes an earlier version for 2014 and includes new sections and a more detailed timeframe for post-inspection actions.
 
Following inspections, EMA says that lead inspectors should propose deadlines for responses to inspection findings, which should routinely be set at 30 working days from receipt of the inspection report.
 
EMA explains that the responses should be made in the form of a corrective and preventive action (CAPA) plan, which 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 stipulated.
 
The guideline includes new sections discussing how to manage unacceptable responses to inspection findings, sharing of inspection reports, periodic progress reports and post-inspection meetings.
 
In rare cases where inspections are closed despite inadequate responses on the part of a marketing authorization holder (MAH), EMA says that the conclusions regarding the inadequate responses should be documented and that, “Any irrelevant or inappropriate content added to the inspection report by the MAH should be removed or redacted by the lead inspector.”
 
EMA explains that inspectors may request periodic progress reports on CAPA implementation in some cases. “Periodic progress reports can be useful in instances where the MAH has had previously identified issues with CAPA implementation or where a CAPA plan includes actions with long timeframes for implementation,” EMA writes.
 
The guideline also includes new sections on re-inspection planning and communicating inspection findings to regulators outside the EU.
 
After inspections are closed, EMA says 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 for significant major findings, a timeframe of 24-36 months. For less serious findings, EMA says a “re-inspection should be performed as part of a routine risk-based inspection programme.”
 
As for information sharing with non-EU regulators, EMA says the sharing of serious non-compliance issues “may be required on a case by case basis,” and done under applicable confidentiality arrangements. In the case of inspections in countries outside the EU, EMA says it will contact local authorities to notify them of an inspection and invite them to observe. “However, the inspection outcome may only be shared whenever confidentiality arrangements are in place,” EMA writes.
 
EMA