Pharmaceutical companies must comply with Pharmacovigilance (PV) regulations throughout the duration of product development and post-marketing product lifecycle. Some of the challenges the industry faces includes: keeping pharmacovigilance staff, maintaining drug safety monitoring and being compliant with regulatory requirements.

What are the Pharmacovigilance Requirements?

Pharmacovigilance is defined as the “science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems.”1 This is part of Health Canada’s mandate to maximize the safety, quality and efficacy of health products and is implemented in the Good Pharmacovigilance Practices (GVP) inspection program.

The GVP inspection program ensures the manufacturer meets the Food and Drug Regulations pertaining to ADR reporting and on-site monitoring and assessment is routinely conducted. Compliance is assessed by conducting inspections with a different cycle frequencies of these establishments based on a priority ranking scale and a risk-based approach.

Within the context of the GVP inspection program, Market Authorization Holders (MAH) and Importers are subject to GVP inspections and need to ensure that all the requirements of the Food and Drug Regulations are met. The following are the responsibilities of the Market Authorization Holder (MAH) and Importer.

Requirements applicable to MAH:2

• Complaints Procedure
• Adverse Drug Reaction (ADR) Procedures
• Receipt and Evaluation of ADR Data
• Reporting of ADR Data to Health Canada
• Literature Search
• Contractual Agreement
• Validation of Computerized Systems
• Preparation of Annual Summary Report
• Preparation of an Issue-related Summary Report
• Maintenance of Records
• Receipt and Reporting of Unusual Failure in Efficacy for New Drugs

Requirements applicable to Importer:2

• Complaints Procedure
• Adverse Drug Reaction (ADR) Procedures
• Receipt of ADR Data
• Contractual Agreement
• Validation of Computerized Systems
• Maintenance of Records
• Receipt of Unusual Failure in Efficacy for New Drug

With ongoing limitation to resources, companies need to look for ways to meet these pharmacovigilance requirements and be ready for the Regulatory inspections. Global companies perform these PV functions in their interlinked offices however most other companies find the PV workload challenging. Therefore, it is beneficial for them to outsource the PV activities in order to maintain compliance.

Some of these PV activities are:

• Receipt and processing of pharmacovigilance data.
• Submission of expedited reports to regulatory authorities.
• Literature searching.
• Provide medical input into PV.
• Preparation of safety reports (i.e., PSUR, ASRs).
• Signal detection and trend analysis.
• Provide audit support of the PV system.

What are the advantages to outsourcing PV?

• Reduce the costs to recruit, manage or train in-house staff.
• Outsource to an expert whose knowledge and expertise in the business is compliant to current requirements.
• Ensure that you are maintaining a compliant PV process and/or electronic system.
• Outsource to save on all the details of reporting, assessing, literature and meeting the requirements.
• Provide expertise for audit preparation and post audit activities.
• Provide expertise in various markets (i.e., pharmaceutical, biologics and medical devices) and stay ahead of new regulations.
• Have overlapped knowledge and support from experts in adjacent groups (i.e., regulatory, quality, medical).

Don’t worry. AXSource has the knowledge and experience to help you through the PV challenges.

For more information, contact us and we will help navigate and provide expertise for your PV activities.

REFERENCES

1. The Importance of Pharmacovigilance – Safety Monitoring of Medicinal Products, WHO, 2002
2. Good Pharmacovigilance Practices (GVP) Guidelines (GUI-0102), Health Canada, Aug 2013