EMA survey on initial marketing authorisation application 2016

News 15/09/2016

The European Medicines Agency (EMA) is undertaking a survey on the centralised evaluation procedure, from pre-submission to opinion finalisation.

Marketing authorisation applicants will be directly asked for feedback on the following three steps of the centralised evaluation procedure:

  • pre-submission to validation;
  • primary assessment phase (D1-D121);
  • opinion finalisation.

In parallel, and to enable feedback from both the applicants' and regulators' perspective, EMA staff and rapporteurs involved in these three procedures will participate in a similar survey.

Once the survey is finalised and the responses analysed, the findings will be discussed with industry stakeholder associations in the stakeholder platform on the operation of the centralised procedure in the second quarter of 2017. A report summarising the findings will also be published on the EMA website.

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