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
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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
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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) (PDF/121.84 KB)
Draft: consultation closed
First published: 27/07/2015
Last updated: 27/07/2015
Consultation dates: 27/07/2015 to 30/09/2015
EMA/CHMP/697051/2014 Rev. 1 -
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Procedural advice on the accelerated assessment of marketing authorisation applications pursuant to Article 44 (3) of Regulation (EU) No 2019/6 (PDF/277.29 KB)
First published: 17/07/2006
Last updated: 22/04/2022
EMA/CVMP/32995/2006 Rev. 1