Decline In Number of MHRA InspectionsIn the UK, the MHRA publishes pharmacovigilance inspection metrics each year. During the period of April 2018 to March 2019 the MHRA conducted 18 inspections of Marketing Authorisation Holders. There has been a trend developing, in recent years, that has seen the number of inspections fall year on year. For example: In the period April 2016 -March 2017 the MHRA conducted 36 inspections. For the 12 months prior to that, they conducted 34 inspections. compared with 47 for 2014-2015 and 56 for the period 2013 to 2014. The statistics provided below were sourced from the UK Government site and were updated in April 2020.
|MHRA Inspection Statistics April 2014 – March 2019
|Number of Inspections
|April 2018 – March 2019
|April 2017 – March 2018
|April 2016 – March 2017
|April 2015 – March 2016
|April 2014 – March 2015
What Were The Most Commonly Occurring MHRA Findings?In the April 2015 to March 2016 reporting period, the most commonly cited critical finding was ‘supervision and oversight’ at 28%. This category includes issues in relation to the provision of complete and accurate information to national competent authorities and inspectors, maintenance of the PSMF and QPPV/ MAH oversight of the pharmacovigilance system. ‘MAH oversight’ accounted for 11% of critical findings in 2014-2015 and was not listed as a category in the 2013-2014 report. This represents an upward trend in the findings in this area. The second most cited category for critical findings in 2015-2016 was both ‘Data management’ and ‘Reference safety information (RSI)’, both at 18%. RSI includes failures and significant delays to submit safety variations to update the safety sections of SPCs and PILs. RSI seems to have seen an improvement in MAH compliance in recent years, as it represented 29% and 42% of critical findings in 2014-2015 and 2013-2014, respectively. Data management was not a category in previous reports and includes issues with collation and integrity of the global safety dataset, ICSR handling, and safety database validation, configuration, and control. On major findings in 2017-2018, the top two cited were risk management (25%) and the management of a quality system (21%). Here in Ireland, the HPRA conducts a limited number of PV inspections each year, with only 4 pharmacovigilance inspections taking place in 2017 (HPRA Annual report 2017).
Ask yourself the following questionsFrom our experience with the MHRA, a key focus at present is QPPV oversight and influence. The QPPV must continue to be aware of all aspects of safety related to the medicinal product(s). This is an extremely wide net and QPPVs should be able to satisfy themselves with all the following, as outlined in GVP module 1:
- Does your QPPV have the skills for the management of the pharmacovigilance system and have adequate theoretical and practical knowledge? Simply assigning a member of staff to this position that does not have extensive experience in the area is not acceptable and will be cited by national competent authorities.
- Is the information in the PSMF accurate and up to date at all times? Is it a true reflection of how the pharmacovigilance system is executed on a day-to-day basis?
- Do you have sufficient oversight of all third parties, for example, distributors? Have you got robust safety data exchange agreements in place? Are you performing reconciliation activities at appropriate intervals? Have you ensured all third parties have received initial and refresher pharmacovigilance training? Have all third parties been included in your audit schedule? Have you assessed risks when deciding on your audit plan for third parties?
- Do you have oversight over the functioning of the system in all relevant aspects, including its quality system (e.g. standard operating procedures, contractual arrangements, database operations, compliance data regarding quality, completeness and timeliness of expedited reporting and submission of periodic update reports, audit reports and training of personnel in relation to pharmacovigilance)