Next Steps

From the moment of their (tacit) approval, transitioned clinical trials will need to comply with all Clinical Trial Regulation requirements, including but not limited to:

Obligations of notification
New safety reporting rules
Archiving requirements
Transparency rules including deferrals for making certain documents publicly available
New labeling requirements (adding an expiry date to the primary packaging)
New procedural rules for requesting a substantial modification, the addition of Member States
Publication of a summary of results, etc.

With the next substantial modification or addition of a new MS, the sponsor will need to complete the application dossier in accordance with the documents required by Annex I of the CTR, at least concerning that part of the application dossier which will be assessed in the procedure (e.g., in case of a substantial modification on Part II only, a sponsor should complete all elements related to Part II of the dossier relevant for the Member State(s) concerned by the substantial modification).

The sponsor will need to complete the application dossier in accordance with the documents required by Annex I of the CTR.

Streamline Your Transition to the CTR with PSI CRO

The new European Clinical Trials Regulation is designed to improve coordination between Member States and simplify the regulatory submission process for future trials. However, when the CTR takes effect, there will be new questions and unforeseen considerations for sponsors when applying the new regulations to their specific trials. A partner experienced in the EU regulatory landscape can help you proactively plan for these challenges and streamline your path to compliance.

PSI’s global regulatory affairs team has helped sponsors overcome these obstacles for the past 25 years and has developed deep insights into the thinking of European regulatory authorities.

Don’t wait to start planning for the transition of your current trial – get in touch with us today.

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