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Part I:  What Do the Regulatory Agencies Know About You? What Regulatory Agencies learn about you an

The Merriam-Webster dictionary defines foreshadowing as “an indication of what is to come.” In many ways, regulatory agencies foreshadow what is important for them to inspect when they evaluate a company’s pharmacovigilance department.

Clearly, having a view into what is “on the test” would be beneficial for an organization as they prepare for an audit or inspection. This first in a two-part blog series from Drug Safety Navigator (DSN) will share key insights into what regulatory agencies are looking for, what they know about you, and how best to prepare for a successful outcome.


One of the first and most logical insights is to review the websites of the inspecting agencies because the majority publish details about their inspection focus and metrics. For example, the Medicines and Healthcare Products Regulatory Agency (MHRA) publishes their GPvP Inspection Metrics, which provides a valuable information about how they conduct inspections.

Besides outlining the number and type of inspections, they also provide their inspection approach and information on inspection findings. For instance, the report on inspections conducted between April 2017 and March 2018 included detailed information on the following types of findings: Risk Management, Quality Management Systems, and Ongoing Safety Evaluation.

At the outcome of inspections conducted between April 2017 and March 2018, the agency felt issues related to Risk Management was an area of specific concern as the highest number of major findings were in this area. One finding stated “The Marketing Authorization Holder (MAH) lacked documentation for the implementation of oversight and monitoring by the EU QPPV of the adherence to RMP commitments.” Additionally, the topic of reference safety information continues to be a common area of non-compliance as observed on inspection. “There have been an increasing number of findings in relation to additional activities and measures required in parts III and V of the RMP respectively, including seven major findings reported for deficiencies with additional pharmacovigilance activities (e.g. PASS) compared with two in the previous reporting period.” (Source: MHRA Pharmacovigilance Inspection Metrics Report: April 2017 - March 2018)

The largest proportion of minor findings were related to Quality Management Systems In one example, it was found that an “MAH had failed to ensure appropriate oversight of the pharmacovigilance system. The system was not fully represented in the pharmacovigilance system master file (PSMF) and this had an impact on the planning and conduct of the inspection”.

The MHRA clearly identifies the importance of a sound PV quality management system stating, “The most common major findings reported in relation to quality management during the current reporting period were findings in relation to the management of audits and deviations including CAPA management. The ability for MAHs to identify non-compliance and effectively resolve it is essential to ensure that pharmacovigilance requirements are met and to uphold the safety of patients. Under the issue of Ongoing safety evaluation, findings included “The MAH did not have the appropriate mechanisms and systems in place to allow for adequate ongoing safety monitoring, including signal detection." Under Management of adverse drug reactions a finding of interest included “A minor failing related to management of social media program”.

The Food and Drug Administration (FDA) publishes their Compliance Program Guidance Manual. Chapter 53 in that manual is titled: “Post-marketing Surveillance and Epidemiology: Human Drug and Therapeutic Biological Products Post-marketing Adverse Drug Experience (PADE) Reporting Inspections”. This is a great source for preparing for a FDA pharmacovigilance Inspection (see link).

Areas covered in an FDA post-marketed pharmacovigilance inspection includes:

• Written Procedures • Source Data Extraction • Waivers • Follow-up Information • Post-marketing Studies • IND Trials Involving an Approved Drug Product • Pharmacovigilance Agreements and Safety Data Exchange Agreements • Corporate Transitions • Special Distribution Systems • Foreign PADE Reporting • PADEs Reported to the Firm’s Legal • Department Scientific Literature Reports • Complaint Files • Periodic Safety Reports • NDA and ANDA Annual Reports • PADE Reporting Requirements for OTC Monograph Drugs • Electronic Submissions • Part 11 Compliance • PADE Collection & Reporting by Non-applicants

Another tip is to search the FDA website for pharmacovigilance inspections where a Form 483s and/or a Warning Letter were issued to learn more about the focus of their inspections.


In preparing for an inspection you should review what an agency knows about your company. That includes reviewing everything that has been sent to an agency such as; all expedited reports, periodic/annual reports, applications, waivers, and safety reference material (package inserts etc…). If there is a compliance issue with anything that was sent to an agency, such as a late expedited report, there should be documentation of the deviation and any actions implemented to address the root cause of the noncompliance issue.


So clearly, you can see past findings foreshadow what is important to regulatory agencies as it relates to upcoming inspections. At DSN, we work with companies to apply a risk-based approach to develop an inspection strategy that will ensure companies are prepared for the inevitable audit. In addition to our Director of Quality with decades of experience in global inspections, systems validation documentation, and audit preparedness, our DSN team includes a former FDA inspector with extensive experience with inspection preparation and mock audits. DSN applies pharmacovigilance practices that will help your organization sail through a regulatory inspection. And most importantly, we ensure a safe risk benefit profile for your product. Part II of this blog will focus on steps your organization should take to be in the best position for a successful inspection. Stay tuned for that blog soon!

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