GENINVO Blogs

Clinical Trial Regulation and EMA Policy 0070 restart

EMA policy 0070 Relaunch in September 2023 – What you should need to know! 

EMA Policy 0070 is to be relaunched in September 2023. This was announced by the European Medicines Agency during a webinar held on May 16, 2023. 

All Marketing Authorization Holders who submit packages to EMA should immediately implement document anonymization processes. 

EMA Policy 0070, which was originally implemented on January 1, 2015, has been around for almost a decade. The suspension of EMA Policy 0070 in December 2018 was due to the COVID Pandemic. But now, EMA Policy 0070 will be reactivated. 

What is the scope of this document?

Sponsors should be aware that EMA Policy 0070 has remained largely unchanged, but some changes have been made to the procedures. 

The scope of relaunch includes 

  • New Active Substances (NAS), September 2023   
  • Negative and withdrawn goods   
  • COVID-19 (and other Public Health Emergency Clinical Data)   
  • MAHs affected will receive detailed, specific letters inviting them to request the packages   
  • Meetings to discuss the scope of publication, anonymization strategy, and commercially sensitive information CCI strategy.   

Changes to improve efficiency and continue collaboration with Health Canada.

What’s new in EMA Policy 0070 relaunch? 

The EMA Policy 0070 Team will work closely with the Clinical Trial Information System team (CTIS) to ensure that both efforts are uniform and consistent. The EMA wants to complete package preparation as soon as possible – as soon as the sponsors receive a letter of invitation from EMA in relation to EMA Policy 0070. 

Pre-submission meetings will be tailored to each product. The scope of publication as well as anonymization will be discussed at this meeting. 

The EMA will develop new templates for anonymization reports in collaboration with Health Canada. It will also draft a list for the marketing authorization holder of the documents that are eligible for anonymization. 

Re-launching EMA Policy 0070 enhances transparency and public trust in clinical research by allowing researchers and healthcare professionals access to clinical data. This policy will enhance the scientific integrity and safety of healthcare decisions by ensuring efficient and safe clinical trials. 

Key Points from Webinar 

  • Any submission getting decision from September 2023 would be eligible to submit the anonymized package as per Policy 0070. 
  • Submission done after suspension of Policy 0070 after Brexit and before September 2023 would not need to be published immediately but it would be done based on request and proper planning to avoid burden on Sponsors and EMA. 
  • Invitation letters will be sent if your product is in scope. 
  • Emphasis on 1) early preparation of packages for submission – prior to Opinion and 2) Complete QC check prior to submission – all documents present. 
  • EMA worked collaboratively with Health Canada to create a common template for anonymization report. 
  • EMA Policy 0070 Team will work closely with the Clinical Trial Information System team (CTIS) to ensure that both efforts are uniform and consistent. However, anything redacted as CCI for CTIS does not make it eligible for CCI for Policy 0070. Following were the major reasons of rejection of CCI and shall be considered for future: 
  • Information is already in public domain. 
  • Specific details shall be redacted as CCI in place of complete paragraphs. 
  • Lack of Proper justification for CCI to explain how it impacts economic benefit of the sponsor. 
  • Covid-19 projects are still of interest to the public and will continue to be published under Policy 0070 even if a decision on it is made before September 2023. 
  • Timelines have been revised from 60 days to 120 days for publishing the anonymized package from the date of CHMP opinion on initial marketing authorization applications. 

Important Links:

[1] https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trial-regulation

[2] https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/clinical-data-publication

[3] https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/profile-public-release-clinical-information-guidance/document.html
[4] Clinical Data Publication (Policy 0070) re-launch – EMA webinar | European Medicines Agency (europa.eu)

By Parveen KumarHead of Data Transparency & Product Owner, GENINVO

For questions on this article, please contact us.

More Blogs

Transforming Document Creation in Life Sciences with DocWrightAI™ – GenInvo’s Advanced AI Assistant!

Transforming Clinical & Regulatory Medical Writing through the Power of AI!  GenInvo is leading the way by accelerating the availability of…
Read More

Embracing the Digital Era: The Transformative Power of Digitalization in Medical Writing

In recent years, the widespread adoption of digitalization has revolutionized various aspects of society, and the field of medical writing…
Read More

Data Masking and Data Anonymization: The need for healthcare companies

In the healthcare industry, the protection of sensitive patient data is of utmost importance. As healthcare companies handle vast amounts…
Read More

Artificial Intelligence in the Healthcare Domain: How AI Reviews Clinical Documents

Let’s know what Clinical Documents are.  Clinical Documents are written records or reports documenting various aspects of patient care and…
Read More

Importance and examples of usage of Data Anonymization in Healthcare & Other sectors

Data anonymization plays a critical role in healthcare to protect patient privacy while allowing for the analysis and sharing of…
Read More

Data Anonymization and HIPAA Compliance: Protecting Health Information Privacy

Data anonymization plays a crucial role in protecting the privacy of sensitive health information and ensuring compliance with regulations such…
Read More

Automation of Unstructured Clinical Data: A collaboration of automation and Medical Writers

In the field of healthcare, clinical data plays a crucial role in patient care, research, and decision-making. However, a significant…
Read More

Quality Control of the Methods and Procedures of Clinical Study

Methodology section of the Clinical Study Report (CSR) provides a detailed description of the methods and procedures used to conduct…
Read More

Automated Quality Control: Get the best out of your Clinical Study Report Review 

What are Clinical Study Reports?  Clinical study reports (CSRs) are critical documents that summarize the results and findings of clinical…
Read More

Clinical Study Results: Quality Control on study findings and outcomes

Clinical Study Reports, or the CSRs, are comprehensive documents providing detailed information about the design, methodology, results, and analysis of…
Read More

Big Save on Time > 60%, A case Study: DocQC™ Tested on 25 Studies.

Medical Writers have provenly spent a lot of time historically, in reviewing the Clinical Study Reports. Clinical Study Reports, or…
Read More

Data Anonymization in the Era of Artificial Intelligence: Balancing Privacy and Innovation

Data anonymization plays a crucial role in balancing privacy and innovation in the era of artificial intelligence (AI). As AI…
Read More

Automated Quality Control: Get the best out of your Clinical Study Report Review

What are Clinical Study Reports?  Clinical study reports (CSRs) are critical documents that summarize the results and findings of clinical…
Read More

Data Redaction: Safeguarding Sensitive Information in an Era of Data Sharing

Data redaction is a technique used to safeguard sensitive information in an era of data sharing. It involves selectively removing…
Read More

10 Best Data Anonymization Tools and Techniques to Protect Sensitive Information

Data anonymization plays a critical role in protecting privacy and complying with data protection regulations. Choosing the right data anonymization…
Read More

Building a Strong Foundation: Robust Metadata Repository (MDR) Framework for Automated Standard Compliant Data Mapping

Pharmaceutical and biotechnology companies operate within a constantly evolving regulatory landscape, where adherence to standards set by organizations like the…
Read More

Digitalization of Medical Writing: Balancing AI and Rule-based algorithms with Human Supervision in Medical Writing QC

What is Digitalization of Medical Writing?  The digitalization of medical writing refers to using digital technologies and tools to create,…
Read More

The Rise of Differential Privacy: Ensuring Privacy in the Age of Big Data

The rise of differential privacy is a significant development in the field of data privacy, especially in the age of…
Read More

Role of Intelligent Automation: How Intelligent Automation transforms the Clinical Study Document Review in Real Time

Clinical Study Reports play a critical role in assessing the safety and efficacy of new medical treatments. Review of these…
Read More

Automation on Clinical Study Report: Improve the Speed and Efficiency of document review. 

Clinical Study Report (CSRs) are critical documents that summarize the findings and results of clinical trials. These reports require a…
Read More

Contact Us​

Skip to content