Assessment of Part I or Part I/II

The assessment period depends on the type of application.

The maximum period for the assessment phase is 45 days with the possibility to extend this by another 31 days (12 days for the sponsor and 19 days for the MS) in case the rMS send a request for information (RFI). The sponsor shall submit the requested additional information within the period set by the rMS (maximum 12 days).

The rMS can send multiple RFI to the sponsor as long as the maximum timeline is not exceeded taking into account the time for the sponsor to respond and the time for the MSc to assess the requested additional information. This means that during the initial 45 days multiple RFI can be submitted trough CTIS at any time. However, the aim is to have only one RFI for a clear and transparent process.

If a MS does not meet its timelines for the part I assessment there is no assessment report and no conclusion on part I. This means that no MS can take a decision. In that case, the sponsor has to resubmit its application dossier. If a sponsor does not meet its timelines the application will automatically lapse.

Multinational clinical trials

For multinational clinical trials, the 45 days of the assessment of part I is divided into three phases:

  • An initial assessment phase performed by the rMS (max 26 days);
  • A coordinated review phase involving all MSc (max 12 days);
  • A consolidation phase performed by rMS (max 7 days).

In case of RFI, the sponsor has maximal 12 days to respond on the RFI. The additional information is reviewed by all MSc. The 19 days review are divided in two phases:

  • A coordinated review phase involving all MSc (max 12 days);
  • A consolidation phase performed by rMS (max 7 days).

MSc can submit their considerations via CTIS within the timeline set of the coordinated review phase. These considerations have to be taken into account by the rMS. The rMS finalises the assessment report part I and distributes the report together with its conclusion via CTIS. The date on which the final assessment report Part I is submitted to the sponsor and the MSc is the reporting date.

The MSc finalises the assessment report part II for their MS and distibutes the report together with its conclusion via CTIS.

Extended assessment

For clinical trials involving advanced therapy investigational medicinal products or medicinal products as defined in point 1 of the annex to the Regulation 726/2004*, Article 6.7 of the CTR allows the rMS to extend the assessment period for part I by an additional 50 days, for the purpose of consulting with experts. However, the extension of the timelines for the assessment of part II is not provided for by the legislation. This may result in part I having extended timelines compared to Part II and leading to particularly complex outcomes. Therefore, sponsors may consider applying Article 11 of the CTR in cases of complex applications, thereby submitting part II separately from Part I.

* These are medicinal products developed by means of one of the following biotechnical processes:

  • Recombinant DNA technology;
  • Controlled expression of genes coding for biologically active proteins in prokaryotes amd eukaryotes including transformed mammalian cells;
  • Hybridoma and monoclonal antibody methods.