The Applicant Guide: New active substance applications under Regulation 1107/2009 – optional 'phased submission' process
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This is a national procedure for applicants wishing to apply for first approval of a new active substance under Regulation 1107/2009. It provides an opportunity for pre-application evaluation of studies with the aim of improving the efficiency of the regulatory process. Use of the procedure is optional and proposals are subject to agreement by CRD.
Overview and objectives
CRD recognises that when companies are compiling regulatory dossiers for new active substances a significant proportion of the studies may be available well in advance of the anticipated application date. Longer term and higher-tier studies, together with the need to compile risk assessments, are generally the rate-limiting steps that dictate the formal application date. CRD is therefore willing to consider the submission of a set or group of studies for evaluation prior to the submission of the formal application for approval being made under Regulation 1107/2009. The result of this pre-application submission would be limited to hazard evaluation and endpoint determination for the submitted studies and would not, given the absence of a complete dossier, involve risk assessment.
CRD's objectives in introducing this phased submission approach are to:
- provide a greater degree of certainty to applicants on endpoints for use in the risk assessments to be provided with the formal application;
- allow early identification of areas that may need further consideration by the applicant prior to finalisation of their application;
- where appropriate, support global harmonisation by allowing early study evaluations to be made available to work share partners.
It is considered that use of the procedure will reduce the number of post-application technical questions and requests for revision. It also has the potential to reduce the time from formal application to production of the draft assessment report (DAR) although this is not a guaranteed outcome.
Details
It is envisaged that a prospective applicant would identify an active substance as a candidate for this phased submission process. In the first instance they should contact CRD setting out their proposal: Link to Contact Details Page.
The proposal should:
- provide background on the active substance and the intended date for the formal application;
- identify the studies that would comprise the pre-application submission and the proposed date for their submission (this could be a year or more before the intended formal application date). CRD would need to be assured that a significant number of studies would be available to support an efficient evaluation process without disproportionate resource being required for management/co-ordination;
- identify the remaining studies that will be submitted with the formal application.
As the phased submission process is a national measure, the decision on whether or not any given proposal is acceptable will rest with CRD. In making that decision CRD will take into account:
- the extent of the pre-application submission (primarily whether a sufficient body of studies is available to justify the approach);
- proposed dates of pre-application submission and the formal application
Assuming the proposal is acceptable it is likely that a meeting would be necessary to consider the detail of the submission and timelines for the project. For the pre-application submission it is considered that the framework of the OECD dossier format would also be used and the studies should be accompanied, in principle, by document M study summaries, a reference list and an endpoint list completed as far as possible given the partial nature of the submission.
Fees
The fee for the pre-application submission would be based on CRD's partial dossier fee structure. The fee would be determined and charged immediately after receipt. The formal application would also be charged on this basis, however, an additional 'completeness check' fee would also be payable. Prospective applicants should note that it is likely that the total fee, for the pre-application evaluation followed by the subsequent evaluation of the complete dossier supporting the formal application, is likely be greater than the current fee for the evaluation of a core dossier given the greater co-ordination resource required.