EU Clinical Trial Regulations

Top 4 Ways the EU Clinical Trial Regulations Will Impact the World

The way we conduct clinical trials in the European Union (EU) will experience a significant transformation when Regulation (EU) No 536/2014 goes into full effect in late January 2022. In May 2014, the EU officially published this new regulation. It was to replace the EU directive No. 2001/20/EC. However, technical difficulties with the new database delayed the launch, and the European Medicines Agency (EMA) pushed back the timeline.

In July of this year, the European Commission announced that the Clinical Trials Information System (CTIS) is fully functional, based on an independent audit of the new system, and will go live on January 31, 2022.

This new regulation has been dubbed a “game-changer” for clinical trials conducted in Member States of the EU and will impact the trial process and sponsors worldwide. The EU Clinical Trial Regulations (No. 536/2014) will harmonize the requirements for clinical trials throughout the EU by establishing the CTIS as a unified portal and database to house all clinical trial information published.

The EMA will maintain the system in collaboration with the EU Member States and the European Commission. The primary purpose of this regulation is to produce more beneficial conditions for clinical trials conducted in the EU Member States.

Key Points:

  • The European Union (EU), with its centralized clinical trials portal, will save trialists and sponsors time by streamlining the trial process
  • They are also making it easier for patients to find research studies that they may be eligible to participate which is beneficial across all sectors of society
  • This new process puts patients first, and they must continue being at the center of our focus 
  • The 24 different official languages in a region make it difficult to translate efficiently and reliably. But with the right tools, this is done more efficiently 

The Clinical Trials Information System (CTIS): A Centralized Portal

The CTIS will replace the de-centralized methods for managing submissions of clinical trials. It is a paperless system that covers the lifecycle of every clinical trial conducted by the EU Member States.

All those who use the new system will benefit from the integration of this database, as it will improve efficiency and increase data quality. The CTIS will enable everyone throughout the world to:

  • Review clinical trial statistics and download reports of collected data
  • Access clinical trial data in non-technical language
  • Perform advanced searches of all clinical trials
  • Obtain notifications for site updates

Trial sponsors will be able to submit a single dossier through the EU portal to all Member States. It will create some significant translation challenges for trial sponsors.

However, many of these challenges will provide opportunities that will ultimately help sponsors generate trials in plain language pursuant to the new EU Clinical Trial Regulation.

How the EU Clinical Trial Portal Will Work

The CTIS is an entry point for submitting clinical trial data and will support the daily processes for the Member States and their sponsors with a user-friendly portal. It will provide regulatory management with effective tools for monitoring.

This portal will impact collaborative tools, document management, and workflows for specific workspaces. These include the following:

Workspace for Sponsors

A guarded workspace will support clinical trial sponsors in developing and organizing data to submit to the Member States for assessment using the system. It is a critical step towards ensuring all necessary information and other relevant documents are available for review.

This workspace allows sponsors to:

  • Manage users and their roles
  • Upload documents for application submission
  • Collect dossiers for all clinical trial
  • Cross-reference other clinical trials
  • Research clinical trials and access their information
  • Get notifications for continuing clinical trials
  • Answer information requests
  • View deadlines
  • Record clinical trial results

Authority Workspace

A guarded workspace will support clinical trial sponsors in developing and organizing data to submit to the Member States for assessment using the system. It is a critical step towards ensuring all necessary information and other relevant documents are available for review.

This workspace allows the Member States to:

  • Manage users and their roles
  • Preview all application dossiers
  • Cooperate with the other Member States
  • Deal with tasks related to clinical trial assessment
  • Obtain notifications for continuing clinical trials
  • Download documents presented by trial sponsors
  • Record examinations of sites and clinical trials

Public Access Website

The EU Clinical Trial Register website is an open-access resource that provides information on all clinical trials conducted in the EU, available at any time. Qualified translators will help make this data available to members of the public in the official EU languages.

The website will provide the following features:

  • Summarize the statistics of clinical trial
  • Provide enhanced searches
  • Download data and reports
  • Provide notifications of site updates

4 Ways the EU Clinical Trials Regulations Will Impact Translations 

The new EU Clinical Trial Regulation will bring about a series of challenges that are even more difficult to manage during the transition period. In the wake of the EU law, trial sponsors may need to adjust their processes and workflows. They must now meet and also exceed strict timelines set out by this new legislation.

The passage has led us into an era where companies all over Europe must abide by stiffer rules that guarantee patient safety while still trying to maintain efficiency throughout each step along the way—from initial diagnosis until approval from local authorities upon receiving notification from abroad.

Here is how this new regulation will impact sponsors and translators throughout Europe (and the rest of the world’s population):

1. Identifying a Primary Language

As soon as the trial is over, sponsors should have the capability to manage any translation gaps. With a centralized strategy like this one, there will no longer be an issue with translating for participants, and they can continue their journey knowing what every word means without having confusion about specific phrases or information.

Likewise, this regulation identifies a primary language for trial documentation for portal submissions. There are 28 languages spoken in the 24 countries in the EU.

Dossier content, documents for participants, and data reviewed by the ethics committees will require translation. As a result, sponsors must find a streamlined approach to managing language translation into a primary language and in non-technical communication.

2. Streamlining the Authorization Process

The new centralized portal eliminates the need for trial sponsors to complete individual submissions. This development is a vast improvement from previous processes and will save sponsors valuable time.

The recent change in regulation means that moving forward, all international drug trials submissions will be completed through one central website instead of multiple countries’ websites. This approach should eliminate much confusion when deciding if a study qualifies as regional. Therefore, it will streamline the authorization process.

3. Fast-Tracking Timelines for Reviews

As a result of the new regulation, trials will be much easier and more efficient. The single submission system can save everyone time from going through multiple agencies or departments in a process that is currently an arduous one.

It reduces trial authorization by more than two weeks, and this process requires sponsors and the Member States to comply with the timelines to complete assessments. The new process timelines are:

  • Initial assessment phase: 26 days
  • Coordinated review stage: 12 days
  • Consolidation stage: 7 days

This new timeline will create a time crunch. However, streamlining your workflow will make this task seem far less strenuous. Moreover, these stricter deadlines will require tighter collaboration.

4. Focusing on Improving Transparency

Transparency is a crucial element of the new regulation. With increased demands for transparency comes a need to respond in kind. The European Commission is calling for clinical research data to be more accessible by the public. Trial sponsors who do not comply will face strict penalties.

This regulation will produce new challenges for the scientific community. However, it will also create more confidence in the public in scientific research and medicinal product development.

Advantages and Challenges of the Clinical Trial Regulations 

The purpose of the Clinical Trials Regulation is to produce a favorable atmosphere for conducting clinical trials in Europe, with high standards on safety and transparency. The chief advantages of this new regulation lie in the requirements of this new system.

Not only will this regulation enhance the proficiency and efficiency of all trials conducted in the EU, but it will also foster innovation and research to avoid duplications of clinical trials.

Consistent Rules

The new Clinical Trial Regulation is a much-needed change to ensure consistency in conducting clinical trials throughout the EU.

It requires good manufacturing practices through specified principles. These guidelines ensure that investigational medicinal products, like vaccines, are tested in humans correctly. Inspections guarantee that all operations meet specific standards.

For clinical trials conducted outside of the EU requesting submission for marketing authorization in Europe, these clinical trials must meet these same EU Clinical Trial Regulation standards. They must undergo the same peer-review process and must be registered ahead of time.

Furthermore, the rights and safety of the subjects in the clinical trials must be recorded and submitted at the time of registration. Just as if they were conducted within the EU.

Public Access

The European Union has a long history of transparency concerning clinical trials. These are critical issues because the outcome of these tests can have significant implications for public health and safety, along with patient privacy.

The new regulation will make it more difficult to keep confidential information about trials while still protecting subjects’ privacy.

Information from clinical trials conducted must be made public according to the new regulation. The researchers or pharmaceutical companies involved must now publish their findings in the CTIS.

The transparency regulation affects data collected and monitored closely enough not to be considered reckless experimentation on humans under law.

The data stored in the database must remain publicly available. There are only a few exemptions where this information may remain protected under the Regulation, including:

  • Personal data
  • Marketing authorization status (unless necessary to disclose)
  • Confidential communications
  • Member States supervision

All other information must remain available to the population at large. Furthermore, a full disclosure of the rules must be made available for the implementation of transparency regulations.

Electronic Processes Implementation

Another key benefit of the EU Clinical Trial Regulations is implementing the Member States’ electronic submission and assessment process regarding the clinical trials administered. They must follow a standard that results in full disclosure and complete access for the Member States.

Each clinical trial conducted must be included in the database promptly. Each trial must be thorough and complete and may not leave out any information except for the data protected under the Regulation.


Furthermore, improved collaboration is made possible through information-sharing made available by the CTIS. Not only will this improve collaboration, but it will also ensure effective decision-making and reduce duplication and unnecessary repetition of clinical trials conducted within and between the Member States.

The increased transparency between the Member States of the data in each clinical trial will improve information-sharing and make this data public regarding unsuccessful trials. In turn, this will boost efficiency.

Improves Safety Standards

This new regulation will provide the highest safety standards for subjects who participate in clinical trials performed in the EU. It ensures that researchers take all precautions.

It will also guarantee that each participant gives informed consent. Researchers must also fully inform each subject regarding the trial for which they will be taking part.

Furthermore, safety reporting and recording is required under the new regulation and must include:

  • Adverse events
  • Suspected unexpected severe adverse reactions
  • Data collected regarding actions taken in an adverse event

Moreover, researchers must include clinical trials of more than one investigational medicinal product in the Clinical Trial Eudravigilance database.

Reduced Cost

Finally, the new EU Clinical Trial Regulation will help to reduce costs for trials performed throughout Europe. It also allows the Member States and stakeholders direct engagement in the development of the CTIS moving forward.

This access will provide sponsors with improved and constant opportunities to test, review, select, and verify the functionality of each clinical trial. By evaluating the effectiveness and efficiency of each trial conducted, researchers can reduce overall costs.

Seamless Solutions are Going Live

On April 21, 2021, the European Commission confirmed to the EMA Management Board that the EU Portal and Database are fully functional. In July, they announced that it would take only six months for the CTIS to go live, making it operational effective in late January 2022.

The EMA stated, “It is the desire of the Board, EMA and the European Commission that the system goes live on January 31, 2022, which would imply that the Commission notice in the Official Journal would be published on July 31, 2021.”

Those in the translation, interpreting, and languages fields are ready for better opportunities to provide the public with more access to clinical trial data in a language they can understand. We have been anticipating these changes for a long time.

To ensure the effective implementation that the Clinical Trial Regulation requires, sponsors should work with a trusted translation partner who can act as your centralized resource for all locations across multiple EU countries.

Linguistic experts offer uniform content over all languages, so you can adequately communicate with regulators and trial subjects in their native tongue. It is exceptionally beneficial to ensure no communication barriers when interacting with a global audience of people who speak different languages or have limited English capabilities.