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Pharmaceutical Marketing and Promotional Materials Compliance Audit Checklist

A comprehensive checklist for auditing marketing and promotional materials compliance in pharmaceutical companies to ensure regulatory adherence, ethical practices, and accurate product information dissemination.

Pharmaceutical Marketing and Promotional Materials Compliance Audit Checklist

by: audit-now
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About This Checklist

Ensuring compliance in pharmaceutical marketing and promotional activities is crucial for maintaining ethical standards, regulatory adherence, and patient safety. This Pharmaceutical Marketing and Promotional Materials Compliance Audit Checklist is an essential tool for evaluating the integrity and regulatory compliance of marketing practices and promotional materials. By systematically assessing content accuracy, fair balance of information, off-label promotion risks, healthcare professional interactions, and regulatory approvals for promotional materials, this checklist helps maintain ethical marketing practices and regulatory compliance. Regular implementation of this comprehensive audit process can significantly reduce risks of regulatory violations, enhance the quality of product information dissemination, and support responsible marketing in the pharmaceutical industry.

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Industry

Healthcare

Standard

Pharmaceutical Marketing Standards

Workspaces

Research Facilities

Occupations

Regulatory Affairs Specialist
Medical Affairs Professional
Legal Compliance Officer
Marketing Compliance Auditor
Brand Manager
1
Is the promotional material approved by the regulatory body?
2
Describe any instances of off-label promotion observed.
3
How many interactions with healthcare professionals were documented?
Min: 0
Target: 0
Max: 100
4
Does the promotional material maintain fair balance?
5
Is the digital marketing content compliant with regulatory standards?
6
Are there any ethical concerns regarding the digital marketing practices?
7
How often are promotional messages sent to healthcare professionals?
Min: 0
Target: 0
Max: 1000
8
Is the product information presented in the digital marketing material accurate?
9
Is the promotional review process complete for all materials?
10
Provide a summary of feedback received during the promotional review.
11
How many revisions were required for the promotional materials?
Min: 0
Target: 0
Max: 50
12
Was the promotional material verified for regulatory compliance?
13
Is there proper documentation for all interactions with healthcare professionals?
14
What was the purpose of the interaction with the healthcare professional?
15
How many attendees were present during the interaction?
Min: 1
Target: 1
Max: 10
16
Did the interaction comply with company guidelines for healthcare professional engagement?
17
Has the promotional material undergone a complete content review?
18
Provide any notes regarding the accuracy of the content.
19
How many claims are made in the promotional material?
Min: 0
Target: 0
Max: 20
20
Does the promotional material align with ethical marketing practices?

FAQs

These audits should be conducted at least bi-annually, with more frequent reviews for new product launches or significant marketing campaign changes. Additionally, spot checks should be performed regularly on ongoing promotional activities.

This checklist covers review of promotional material content, assessment of fair balance in product information, evaluation of off-label promotion risks, compliance in healthcare professional interactions, social media and digital marketing practices, and regulatory approval processes for promotional materials.

These audits are typically conducted by regulatory affairs specialists, medical affairs professionals, legal compliance officers, or qualified marketing compliance auditors with expertise in pharmaceutical marketing regulations.

The checklist ensures that all marketing and promotional activities adhere to regulatory guidelines, including accurate product claims, proper disclosure of risk information, and compliance with regulations like the FDA's fair balance requirements and global codes of practice.

If non-compliant materials or practices are identified, actions should include immediate withdrawal or correction of the materials, investigation of the approval process breakdown, retraining of relevant personnel, review of similar materials for potential issues, and implementation of enhanced review processes. All actions must be documented and reported to management.

Benefits of Pharmaceutical Marketing and Promotional Materials Compliance Audit Checklist

Ensures compliance with regulatory guidelines for pharmaceutical marketing and promotion

Reduces risks of regulatory violations and potential legal liabilities

Improves the accuracy and fair balance of product information in promotional materials

Enhances ethical standards in interactions with healthcare professionals

Facilitates consistent and compliant global marketing practices