New Version of Quick Guide for Sponsors

The European Commission has published a new Version 3 of the Quick Guide for Sponsors. The revised guide provides clarifications on the submission of the IMPD-Q (Investigational Medicinal Product Dossier - Quality) for the IMP manufacture at a decentralized point of care (PoC) for clinical trial sites in subsequently added Member States (Section 3.2.1). In case the manufacturing of the IMP is done at a PoC, e.g. at one of the clinical trial sites in the additional MS, there is no placeholder in the CTIS to submit the IMPD-Q for this decentral PoC. To solve this issue, a workaround has been set up and included in the list of known issues and proposed workarounds. Moreover, Section 1 has been revised with updated guidances and best practices for sponsors to transition clinical trials from the CTD (Clinical Trials Directive) to the CTR (Clinical Trials Regulation).

In addition, the Clinical Trials Coordination Group (CTCG) Best Practice Guidance and the template cover letter have been updated (Vs. 2.0) as follows:

  • The consolidated Investigator’s brochure (IB) and/or Investigational Medicinal Product Dossier (IMPD) not previously harmonized under CTD are acceptable when submitting a transition application. Sponsors will be required to have a harmonized or consolidated protocol, IB and/or IMPD for the transitioning. However, it is still required that all other documents common to all Member States Concerned (MSCs), i.e. those documents covered by the Part I assessment report, will be harmonized.
  • If the first substantial modification application after transitioning is a ‘Multi-SM’ submission, where the sponsor submits an IMP-related document in a single request for a substantial modification to several trials (functionality restricted to IB, IMPD and GMP documents), the application dossier should be updated to be in line with the CTR.

More information is available in the Quick guide for sponsors - Regulation 536/2014 in practice published in Eudralex vol. 10 and at the CLINICAL TRIALS COORDINATION GROUP (CTCG) website.

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