The EU ct regulation introduces a new procedure, new timelines, and revised application content. Investigational medicinal product dossier/ĮU Paediatric Investigation Plan decision Suitability of investigators and facilities Justification for the classification as a low intervention Table A: New CT application summary Part I Table B provides a summary of the CT application procedural timelines. The portal will determine when the milestones such as the validation date have been met. If a sponsor fails to reply to a request for information by the deadline, this will lead to the automatic (tacit) withdrawal of the application in all CMSs. If the RMS does not provide validation feedback within the defined time frame, for example, this will be considered a tacit validation of the application. The regulation requires strict adherence to the maximum timelines for each phase of the application procedure and has provisions to ensure that delays from any party do not hold up the process. The validation date is the date the RMS notifies the sponsor of the end of validation, or the natural end of the 10 or 10 + 15 days, whichever comes first. A 15-day extension can be allocated if needed to resolve issues this provides an additional 10 days for the sponsor to respond/update the application and 5 days for member state confirmation, based on the information provided. Member state requests for information during validation should be sent within 10 days of the submission. During this period the member states may request additional information from the sponsor. Validationįollowing submission, there is a validation period to assess whether the application is complete and whether the application is in scope of the regulation. The sponsor’s RMS proposal may not always be accommodated, and in these cases the member state that has either self-nominated or been selected will instead be the RMS. At the time of application, the sponsor proposes a reporting member state (RMS), who will be confirmed by day 6 following submission. The application is submitted via the portal to all concerned member states (CMSs) in which the sponsor intends to conduct the CT (Figure 1). We will learn more as development of the portal and database progress, but we do know that there will be provision for both compiling an application within a workspace facility and for uploading an application that has been compiled outside of the system. User training will be essential it is expected that the EMA will offer system training. Process and timelinesįor many sponsors, the application process may require internal administration to support sponsor registration and role allocation where required by the CT arrangements (e.g., allocating work to contract resource organizations, affiliates, or personnel). There is provision for cross-referencing to existing applications, which will further reduce the current administrative burden of EU CT applications. The application content and assessment are divided into two parts: Part I contains scientific and medicinal product documentation Part II contains the national and patient-level documentation (see Table A). Note: This article does not cover notifications of milestones or unexpected events that are required by the new regulation. In addition, the regulation defines procedural timelines, harmonizes document requirements, and aims to reduce the administrative burden of applications. This procedure not only combines the content of what can be currently referred to as the “regulatory” and “ethics” applications, but also combines the scientific, technical, and ethical review necessary to receive approval to conduct a CT in the EU. The regulation introduces a single approach for the application and maintenance of a CT authorization, and applies to both single or multiple member state trials. While this is a major change, it is also seen by many as a key benefit. The regulation will be applicable by no later than October 2018. According to the most recent European Medicines Agency (EMA) confirmation, 1 The regulation’s effective date is dependent on the availability of the portal and its associated database, which are now in development and subject to user acceptance testing by EMA stakeholders. One of the major changes introduced by the European Union (EU) regulation 536/2014 is an application procedure that will require sponsors to apply for authorization to conduct an interventional/low-intervention clinical trial (CT) via a new EU portal.
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