The Big Picture
The new Metrics Report (1) covers the period from 01-Apr-2020 to 31-Mar-2021, where the MHRA conducted 37 Pharmacovigilance Inspections. A total of 5 critical, 59 major and 76 minor findings were identified during this reporting period. When compared to the previous reporting periods, the average number of findings per inspection has decreased.
The Context
It can be tricky to compare the metrics between periods and the following elements had a significant impact on the conduct of inspections covered by the last report :
- The COVID-19 pandemic: All inspections were conducted remotely.
- Brexit: The UK exited the EU on 31-Jan-2020 and applicable requirements changed.
- A revised GPvP inspection model
Regarding the latter, the MHRA Pharmacovigilance inspection programme has evolved and now includes 4 inspection arms, as follows:
- Routine pharmacovigilance activities
- Risk management and safety communication
- Additional risk minimisation measures (aRMMs)
- Non-interventional post authorisation safety studies (NI- PASS)
in 2020/21, there were 25 inspections (i.e. 68 %) conducted to cover routine pharmacovigilance activities, whereas 12 inspections (i.e. 32 %) belonged to the other arms with focused inspection scopes.
The move towards more targeted inspections led to a significant increase in the number of inspections conducted and the mean number of inspection days per inspection decreased, thus reversing the trend observed in previous periods.
The observed decrease in the number of findings can also be associated to the fact that the inspections conducted during this period had more targeted objectives and a reduced scope.
The Findings
For the five critical findings reported during this period, two were in relation to Risk Management, two for ongoing Safety Evaluation and one was reported for Management of ADRs. The Inspection Metrics Report provides the detail about these findings.
Risk Management remains the topic for which the largest number of critical findings has been reported overall. The two critical findings associated with this topic reported during 2020/21 related to the maintenance of Reference Safety Information (RSI) and additional Risk Minimisation Measures (aRMMs).
As for major findings, the largest proportion of findings was reported in relation to Risk Management and Management of ADRs, followed by ongoing Safety Evaluation and the Quality Management System.
The report includes some detail about the major findings reported over maintenance of Reference Safety Information (RSI). Examples of deficiencies include:
- Delayed safety variation submission
- Failure to maintain Product Information current
- Failures to update Product Information on online platforms (e.g. eMC)
- Delayed implementation of changes in leaflets (PILs) released to market
The highest proportion of findings regardless of grading were in relation to the Quality Management System with most findings reported in relation to Audit and Deviation Management, including CAPA Management.
The Symposium
The MHRA Inspectorate will be hosting its next GPvP Symposium (2) on 10 and 11-Mar-2022, which will be held online.
The Agenda includes a presentation of the Inspection Metrics. Furthermore, the event will include discussions on lessons learnt following the end of the EU Exit Transition period and adaptations to inspection processes by the MHRA and the U.S. FDA in response to the COVID-19 pandemic.
The details of the GCP symposium are also available, which will take place from 07 to 09-Mar-2022.
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