Explanation of the working method Evaluation Manual

The assessment framework as laid down in the Evaluation Manual describes the way in which the Ctgb carries out an assessment. It regularly happens that the Evaluation Manual does not (yet) provide a definitive answer about the way in which a specific topic must be assessed. This may occur, for example, when a Guidance Document leaves room for interpretation. In that case, the room for interpretation is filled by from expert judgment. In the past, it has happened that a discussion has arisen about how to fill this room for interpretation. Applicants sometimes wonder why the Ctgb takes too muny liberties in such cases. However, this is not the case: this is done mainly to fill in what has not (yet) been specified in the Evaluation Manual.

The Ctgb considers it desirable to explicitly state that if during the assessment of a specific situation the Evaluation Manual does not describe in detail how the situation should be assessed, the Ctgb has the freedom to bring in expert judgment not only conduct the assessment under considerartion but also to apply this knowledge to current applications.

Therefore, a brief explanation of the working method has been added to the Evaluation Manual (in Dutch and in English).

The explanation of the method is:
The Evaluation Manual is intended to provide applicants with insight into the assessment framework. This means that in cases where guidance is lacking, still under development, unclear or a specific issue is not included and a consensus agreement has not yet been made the Ctgb will use, case by case, scientific expert judgement in order to perform up-to-date and appropriate risk assessments.

For clarification, the possible routes for changes in the assessment framework are indicated in the diagram below.

Enlarge image Possible routes for changes in the assessment framework
Possible routes for changes in the assessment framework

The line of reasoning for applying the assessment framework is therefore as follows:

  1. We use the assessment framework as laid down in the Evaluation Manual.
  2. New insights are implemented via the assessment framework cycle with a realistic starting date and apply to applications that are submitted from that moment, unless it concerns an insight that requires immediate implementation based on art. 44 Reg 1107 or art. 48 from Regulation 528 (and therefore also possible intervention on existing authorizations).
  3. If a methodology for an application requires expert judgment, it will be applied case specific. In the event of important choices, the Ctgb will communicate this with the applicant.
  4. Inclusion of expert judgment as a structural approach creates a dilemma for inclusion in the assessment framework because the methodology has already been applied specific to the case and causes inconsistency when a starting date is introduced. This will be stated when incorporated into the Evaluation Manual.