Navigating redaction challenges in life sciences: EMA Policy 70

Lucy Hilton Date published: May 27, 24

The groundbreaking European Medicines Agency's (EMA) Policy 70 has shaken up the regulatory landscape for pharmaceutical organizations looking to authorize their products in the European Union (EU). The policy requires such firms to publish the anonymized clinical data of medicinal products.

By understanding the intricacies of Policy 70 and implementing a robust internal redaction process, organizations can not only navigate this specific regulation but also set themselves up for success in adapting to future regulatory and policy changes.

Who is affected by EMA Policy 70?

Pharmaceutical organizations aiming to authorize their products in the EU are directly impacted by EMA Policy 70 and need to ensure they are familiar with the policy and remain compliant. These companies must submit clinical data to support their marketing applications, which are then assessed by the Committee for Human Medicinal Products (CHMP).

Challenges and considerations for compliance

Implementing EMA Policy 70 poses several challenges for life science companies:

1. Rigorous redaction requirements: Organizations must meticulously identify and redact sensitive information, including Personal Private Data (PPD) and Commercially Confidential Data (CCI), to protect patient privacy and commercial interests.
2. Complex submission requirements: Submissions must include various documents, such as clinical overviews, study reports, and protocols, all subject to redaction and anonymization. A thorough understanding of these requirements is essential.
3. Resource allocation: Medical writing teams may face constraints in terms of personnel, time, and technology. Adequate resources and efficient processes are crucial for meeting submission deadlines.
4. Quality control: Maintaining consistency and accuracy across multiple documents is paramount. Robust quality control processes help avoid errors and ensure compliance.

Best practices for EMA Policy 70

1. Leverage extended submission timelines: With the relaunch, companies have a longer window for initial submissions. Utilize this time wisely to avoid last-minute scrambles.
2. Facilitate open communication: Clear timelines, responsibilities, and accountability within the team are essential for smooth submission processes.
3. Understand and implement requirements early: Familiarize yourself with redaction and anonymization requirements from the outset of document creation to streamline the process.
4. Allocate sufficient resources: Plan ahead and ensure adequate manpower and tools to meet submission demands effectively.
5. Emphasize quality control: Implement rigorous quality control measures to maintain consistency and accuracy throughout the submission process.

EMA Policy 70 represents a significant step towards transparency and accountability in the pharmaceutical industry. While navigating its complexities presents challenges, adherence to best practices and proactive planning can streamline the submission process and ensure compliance with regulatory standards.

Technology, such as Ideagen PleaseReview, can greatly reduce the manual efforts required to anonymize regulatory documents. Ideagen PleaseReview ensures that sensitive personal and commercial data is protected, adhering to regulatory or legal requirements. Users can redact sensitive information from PDFs without the need to integrate with Adobe tools and save time by automating a labour-intensive process that is prone to error.

Get the playbook

This playbook serves as an essential resource for pharmaceutical companies, CROs, regulatory bodies and healthcare providers, equipping you with the knowledge to navigate Policy 70 effectively.

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