If you’re a US company looking to start a clinical trial in the EU, Siron Clinical’s eBook ‘Starting a clinical trial in the EU: A guide for US companies’ will help you navigate the process.
The eBook contains a wealth of information and practical tips to help you; here are five things you might not know about running a trial in the EU.
- The clinical trial application process is different in the US and the EU.
The most notable difference in the processes is that in the US, the Food and Drug Administration (FDA) is the central agency responsible for all trial approvals, whereas more than one agency is involved in EU trials.
The EU is made up of 27 countries or Member States. There is a central agency – the European Medicines Agency (EMA) – which plays a role in clinical trial approvals. However, the trial initiation process happens locally.
When you get down to the detail of the submissions, the content required in the US and the EU is similar, despite the differences in the process.
- You need to apply separately in each country, and through the EU.
In the EU, the sponsor submits a clinical trial application (CTA) to each individual country taking part in the trial. This requires some work upfront to work out which agency is in control in the relevant countries. In the eBook, we have included a non-exhaustive table of agencies and links to their websites to help you with this step.
When working on regulatory submissions at the country level, it’s important to have representatives and advisors who are not only legally able to work on your behalf in the EU, but who are also familiar and experienced with the trials process in your countries of interest. Knowledge of the local language is also vital, particularly as some of the documentation will be required in that language.
In addition to applying in each country, a parallel application should be made at the EU level, via the EMA.
- Timelines are more defined in the EU.
One advantage of the application process in the EU is the more defined timelines involved. In the US, the FDA provides a “no news is good news” response – if the sponsor hears nothing, the trial is fine to proceed. The timeline there is undefined, and in our experience, it can take anywhere from two months to a year or longer.
In the EU, timelines are set out clearly, so you can put tentative deadlines on each stage of the process:
• 14-30 days for Phase 1 studies
• 90 days statutory time for ATMP studies
• 60 days statutory time period for all other studies
• 30 days additional time in the case of queries or an incomplete submission
- The rules may be different for advanced therapy medicinal products (ATMPs).
As you can see from the timelines, the process for ATMP studies takes longer in the EU. Advanced therapy medicinal products (ATMPs) are medicines for human use that are based on genes, tissues or cells. They offer groundbreaking new treatment opportunities.
ATMPs can be classified into three main types:
- Gene therapy medicines
- Somatic cell therapy medicines
- Tissue-engineered medicines
The EU does not decide whether gene therapy falls under these directives; rather, Member States are responsible for applying the rules. If you are planning a clinical trial with an ATMP in the EU, it is advisable to check the rules in each Member State specifically relating to the use of ATMPs, as you may need to apply for additional approvals.
- Experience is a key factor in successful EU trials.
Experience is one of the key factors to success in running clinical trials: the more experience you have, the better the project is likely to run. This is one of the findings we share in our RFI on running successful trials in the EU.
However, experience alone does not guarantee success across continents. Understanding the technical and process aspects of the application and approvals processes will give you a good foundation and help you choose the right experienced partners for your trial.
We hope you find the information in the eBook helpful on your journey to running a trial in the EU.