Guideline on the scientific application and the practical arrangements necessary to implement the procedure for accelerated assessment pursuant to Article 14(9) of Regulation (EC) No 726/2004

Based on the experience gathered by reviewing the approach taken to the assessment of past applications since the last version of the guideline in July 2006, it became apparent that some areas of the guideline would benefit from further clarifications, in particular with regards to the justifications provided by the applicant that the medicinal product falls within the scope of the accelerated assessment.

Keywords: Accelerated Assessment

Current effective version

Guideline on the scientific application and the practical arrangements necessary to implement the procedure for accelerated assessment pursuant to Article 14(9) of Regulation (EC) No 726/2004

Reference Number: EMA/CHMP/671361/2015 Rev. 1

Document history

Draft guideline on the scientific application and the practical arrangements necessary to implement the procedure for accelerated assessment pursuant to Article 14(9) of Regulation (EC) No 726/2004 (Revision 1)

Consultation dates: 27/07/2015 to 30/09/2015Draft: consultation closedReference Number: EMA/CHMP/697051/2014 Rev. 1Summary:

The European Medicines Agency is developing a scheme to facilitate development and accelerated assessment of innovative medicines of major public health interest and in particular from the viewpoint of therapeutic innovation to address unmet needs. The criteria for accelerated assessment laid down in this guideline are being considered for the access to this scheme.

Procedural advice on the accelerated assessment of marketing authorisation applications pursuant to Article 44 (3) of Regulation (EU) No 2019/6

Reference Number: EMA/CVMP/32995/2006 Rev. 2