E2E Pharmacovigilance Planning Guidance

• By: Staff Editor
• Date: November 26, 2016
• Source: http://www.fda.gov/

E2E Pharmacovigilance Planning Guidance

This Pharmacovigilance planning guidance is intended to aid in planning pharmacovigilance activities, especially in preparation for the early post marketing period of a new drug. The main focus of this Guideline is on a Safety Specification and Pharmacovigilance Plan that might be submitted at the time of licence application.

The guidance is divided into the following sections:

• Safety specification
• Pharmacovigilance plan
• Annex — Pharmacovigilance Methods

Safety Specification

The focus of the safety specification should be on the identified risks, important potential risks, and important missing information. The following elements should be considered:

1. Nonclinical: This section should present nonclinical safety findings that have not been adequately addressed by clinical data, for example:
   • Toxicity (including repeat-dose toxicity, reproductive/developmental toxicity, nephrotoxicity, hepatotoxicity, genotoxicity, carcinogenicity, etc.)
   • General pharmacology (cardiovascular, including QT interval prolongation; nervous system; etc.)
   • Drug interactions
   • Other toxicity-related information or data
2. Clinical: This section should include the following elements:
   • Limitations of the human safety database
   • Populations not studied in the preapproval phase
   • Adverse events (AEs)/adverse drug reactions (ADRs)
   • Identified and potential interactions, including food-drug and drug-drug interactions
   • Epidemiology
   • Pharmacological class effects

Pharmacovigilance Plan

The pharmacovigilance plan should be based on the safety specification. The structure can be varied depending on the product in question and the issues identified in the safety specification. The pharmacovigilance plan should include:

• Summary of Ongoing Safety Issues
• Routine Pharmacovigilance Practices
• Action Plan for Safety Issues
• Summary of Actions To Be Completed, Including Milestones

Related Training:

FDA and MHRA Pharmacovigilance Inspection Readiness and Management