Two reports published in late 2021 inform reasons behind improving pharmacovigilance compliance.
The drug safety environment is heavily regulated and continuously evolving, with numerous compliance challenges. Since the start of the COVID-19 pandemic, many pharmacovigilance monitoring activities have taken place remotely. Insights gleaned from these reports can help companies remain compliant when conducting pharmacovigilance during COVID-19 and beyond.
Here are the key findings from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA)’s Pharmacovigilance Inspection Metrics Report (2020/21) and the European Medicines Agency (EMA)’s Annual Report of the Pharmacovigilance Inspectors Working Group for 2019 and 2020.
Medicines and Healthcare Products Regulatory Agency PV Inspection Metrics Report
The MHRA’s Good Pharmacovigilance Practice (GPvP) conducted 37 inspections of 36 marketing authorization holders (MAHs), reviewing MAHs compliance with existing EU and national pharmacovigilance guidelines and regulations. The results were shared in MHRA’s Pharmacovigilance Inspection Metrics Report, of which 140 findings were reported.
Five findings were considered critical: two critical risk management findings, two critical ongoing safety evaluation findings and one critical management of ADRs findings.
Of the total findings, risk management was highlighted as the topic for which the largest number of critical findings was reported overall overtime—the findings associated with risk management related to reference safety information maintenance and risk minimization measures. Two critical findings displayed key weaknesses in the MAH PV strategy, which delayed rectification and identification of a specific safety issue with each product. This is the first time that critical findings of the Management of ADRs have been reported since 2015.
EMA’s Annual Report of Pharmacovigilance Inspectors Working Group 2019/2020
The publishing of this report was greatly delayed because of the COVID-19 pandemic, and most of the inspections were conducted remotely in 2020. EMA’s 2019 inspection recorded 24 deficiencies, none considered critical. This is compared to the 2020 report, of which 12 of the total 103 deficiencies reported were considered critical.
Will Your MAH Meet Demand Regulatory Obligations?
The pandemic made pharmacovigilance activities more challenging, especially as they were conducted remotely as safety and PV requirements still applied. Many MAHs were able to adjust, though there is still room for improvement based on critical findings across the UK and EU.
The main areas highlighted for concern across reports included risk management, adverse event reporting, technological compliance for pharmacovigilance, ongoing safety evaluations, and ensuring compliant quality management systems. Reports show that MAHs struggle to meet the regulatory obligations and that companies should seek reputable partners to help them meet their regulatory pharmacovigilance obligations.
Contact PharmaIT from DSI to better understand the EMA and MAH pharmacovigilance findings and how they could apply to your business.
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