Although there are many similarities with the legal environment between Europe and the United States, there are crucial differences that are important to be aware of when undergoing legal proceedings overseas.
The Clinical Trail Application, for example, has a number of noteworthy contrasts that are worth familiarising yourself with before undergoing the process.
- Application: Applications submitted within the EU require CTA (Clinical Trial Application) written approval before any testing can begin, whereas the same process within the United States wouldn’t need the equivalent, an IND (Investigational New Drug Application), to begin the clinical trial.
- Timing: When submitting your findings from a clinical trial within a European country, the length of time you may need to wait for your clinical trial to be approved for the next stage in the process can vary. However, the approval deadline for the FDA in the US is 30-days after they have received the IND, unless there has been an official delay notification.
- Reports: To submit your clinical trial findings for approval to the FDA, you’ll need to have an IND annual report – at the same time in the process within the EU you’ll need to submit an annual safety report instead.
- Fees: When applying for a clinical trial in the US, there are no fees attached to the application, whereas there can sometimes be National Clinical Trail Application fees when going through the same process in Europe.
- Registration: Any clinical trial undergone within a European country will need to be registered in the EdraCT database by the Competent Authorities, where the details will be made public. In the United States, clinical trial needs to be registered on a government site: www.clinicaltrials.gov
If you’re interested in further understanding the new drug approval process within the US, you can download our FDA Drug Approval Process Flowchart here.
Published on Sep 16, 2020 by Lauren Fowles