General comments Stakeholder number General comment (if any) Outcome (if applicable) (To be completed by the (To be completed by the Agency) Agency) EFPIA welcomes the revised draft guidance document on the practical applications regarding the accelerated assessment (AA) procedure in particular the more detailed and revised timeline schedule. EFPIA particularly welcomes the clarification that products which are subject to a conditional marketing authorisation, should be eligible for an accelerated assessment following specific request by the On the procedural side, EFPIA is very applicant. supportive of the introduction of a second possibility without clock-stop. to submit written responses For the revision of the guideline the following aspects are of key importance which will be followed by detailed comments: Distribution of the Rapporteur’s assessment report (AR) is not provided for in the revised guideline. Inclusion of a step for timely provision to the applicant of the Rapporteur’s Assessment Report is critical in order to be prepared at Day 90 and to evaluate if a one-month clock stop can be maintained. Background: Under the current process applicants are provided the draft assessment reports at Day 80 which enables draft response
General comments Stakeholder number (To be completed by the Agency) General comment (if any) Outcome (if applicable) (To be completed by the Agency) EFPIA welcomes the revised draft guidance document on the practical applications regarding the accelerated assessment (AA) procedure in particular the more detailed and revised timeline schedule. EFPIA particularly welcomes the clarification that products which are subject to a conditional marketing authorisation, should be eligible for an accelerated assessment following specific request by the applicant. On the procedural side, EFPIA is very supportive of the introduction of a second possibility to submit written responses without clock-stop. For the revision of the guideline the following aspects are of key importance which will be followed by detailed comments: Distribution of the Rapporteur’s assessment report (AR) is not provided for in the revised guideline. Inclusion of a step for timely provision to the applicant of the Rapporteur’s Assessment Report is critical in order to be prepared at Day 90 and to evaluate if a one-month clock stop can be maintained. Background: Under the current process applicants are provided the draft assessment reports at Day 80 which enables draft response
efpia_comments_ema_gdle_on_aa_final.docx