Our top 15 EU Regulation 536/2014 questions – Part 1

EU Regulation 536/2014 is coming into effect at the end of January 2022. As we approach the date, we are seeing an increase in the number of questions asked by customers about what this means and the implications for their organisation.

That’s why we’ve written this blog post. We’ve collated the top questions we’ve been asked about this regulation over the last couple of months. If we’re missing something you’d like to know more about, please let us know.

1- Does regulation 536/2014 replace anything or is it entirely new?

The regulation will replace the existing Clinical Trials Directive 2001/20/EC.

2- When does regulation 536/2014 come into effect?

It officially becomes a central European law on the 31^st January 2022.

3- Which countries does regulation 536/2014 impact?

Unlike the previous directive, this regulation is automatically binding to all EU/EEA Member states.

However, it does impact any organisation who is conducting a trial in any of these EU/EEA countries, or even simply submitting a Clinical Trial Application to the EMA (even if the trial was conducted outside of the EU).

In summary, if your organisation (regardless of where you are based) wish to market a drug and will submitting this through the EMA, you must abide by the rules of this regulation.

4- How does this regulation affect how I manage my clinical data for the long-term?

The main change will be how you manage your clinical data for the long-term. This regulation stipulates that all data associated with a clinical trial must be retained for a minimum period of 25 years.

This element means far more than storing your data. This goes a step beyond and requires you to retain and maintain your data for this length of time in an appropriate manner/system.

This system must ensure the data can be accessed (by those with permission), read and audited (should you have an inspection requested).

5- When does the TMF need to begin its 25-year retention period from?

According to Article 58, the 25-year period begins at the ‘end’ of the trial.

However, it is up to the sponsor to define when the end of the trial will commence. This is usually classified as the point when the last patient has visited the last site for the final time.

It’s crucial that the sponsor defines when their ‘end point’ will commence within their protocol.

6- What’s the purpose behind this regulation?

This regulation aims to simplify and streamline the clinical trial application process, as well as:

• Ensure the safety of all patients who take part in clinical trials
• Increase efficiency in the registration, conduct and supervision of clinical trials
• Improve clinical trial communication and collaboration
• Create transparency of clinical trial data and information.

7- What is CTIS, how does it relate to Reg. 536 and how will it impact my organisation?

CTIS stands for Clinical Trial Information System and is posed to bring many benefits to organisations involved in clinical trials.

The purpose of CTIS is to create and become the single entry point for clinical trial application submission, authorisation and supervision in the EU.

Up until January 31^st 2022, sponsors should/would submit their clinical trial applications separately based on where they are located. CTIS will streamline this process.

An organisation will now be able to apply for clinical trial authorisation in up to 30 EEA countries with a single application.

Additionally, it will enable coordination of safety reporting – this will contribute to the understanding of the benefits and the risks of medicinal products that are planned to enter or are already on the market of the Union.

8- How does EU Regulation 536 impact my existing closed clinical trials?

The regulation is not retrospectively applicable and therefore does not impact closed clinical trials.

You can read part 2 of this blog series here.