EMA 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

EMA provides further clarification on the accelerated assessment procedure

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.

The scope of this guideline is to provide applicants with guidance on the accelerated assessment request and the practical arrangements necessary to implement the legal provisions on the accelerated assessment procedure. It forms the basis for requesting an accelerated assessment, and should be followed unless otherwise justified. This guideline has to be read in conjunction with Notice to Applicants (Eudralex Volume 2), as well as other pertinent EU guidelines.

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