Clinical Trial Regulation (CTR) EU No 536/2014

During 2021, LINK Medical has prepared for the Clinical Trials Regulation (Regulation (EU) No 536/2014) which became effective as of 31st January 2022. This Regulation replaces the Clinical Trials Directive 2001/20/EC and aims to ensure a higher level of harmonization of the rules for authorizing and conducting clinical trials throughout the EU thus making it more attractive to conduct clinical trials in the EU. The Regulation enables sponsors to submit one single application via the Clinical Trials Information System (CTIS) for approval to conduct a clinical trial in several European countries.

Clinical trial applications can still be submitted according to the Directive during the transition period until January 2023, and studies that have been approved according to the Directive can continue to be managed according to the old process until the end of January 2025. LINK Medical can provide expert guidance to decide on the most suitable process for your trial.

When deciding which process to choose, there are a few important points to consider:

  • Study duration: For long-term studies, the sponsor may want to consider the CTR. If the study will continue beyond 31 January 2025, it will otherwise have to be transferred to CTIS by January 2025.
  • Multiple countries: For applications via CTIS, the assessment of the protocol will be more efficient and will result in a single harmonized protocol in all countries. Adding new countries to an ongoing study is facilitated with the CTR.
  • Short-term studies in single countries: If a quick approval in a single country is wanted, an application according to the Directive may be preferable, even though the approval timelines may depend on the country.
  • Transparency: The Clinical Trials Regulation provides more transparency on clinical trial data. All information in the EU database will be publically accessible unless its confidentiality can be justified on the basis of e.g. protection of commercially confidential information or protection of personal data.

If choosing CTR, LINK Medical’s regulatory team can provide expert guidance on all aspects of the Regulation, help you navigate CTIS in all aspects, and ensure compliance with the CTR.


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