EMA Issues Guidance for Companies Seeking Scientific Advice

Posted 16 May 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) has released revised guidance to answer questions about the process of seeking scientific advice from the agency, including an overview of the scientific advice process and how to prepare a request for scientific advice.

EMA's Guidance for Companies Requesting Scientific Advice, the third revision of which was released on 15 May 2012, covers pre-submission meetings where companies request guidance from EMA staff on scientific issues before submitting their application for approval.

These meetings typically occur 1-2 months before the submission of a dossier, and cover a wide range of topics. EMA's 15 May revision to the guidance addresses 16 topics of interest to sponsors, and answers some common questions.

EMA's guidance explains:

  • All veterinary products are eligible to receive scientific advice.
  • Companies should follow a prescribed format for submitting scientific advice requests.
  • Requests should be sent to EMA at least 1-2 months in advance of the marketing application's submission.
  • EMA requires fees to process requests, but there are no fees if EMA requests an in-person meeting.
  • Committee secretariats should be notified of a sponsor's intent to request scientific advice a month before submission and receive materials at least two weeks before the scheduled meeting.
  • Multiple scenarios exist for receiving feedback from the committee, and different timetables are associated with different scenarios.
  • Companies should expect to hear from EMA regarding their request for scientific advice within 90 days.
  • Applicants will receive a coordinator to handle their scientific request.
  • Some companies will be invited to present their request in person if EMA determines it to be necessary, and will be given two weeks advanced notice.
  • Scientific advice given by EMA is not legally binding.
  • Companies are able to ask for further clarification or a follow-up meeting once EMA has issued scientific advice.
  • Scientific advice given by EMA is considered confidential and will not be published.
  • Applicants for scientific advice may request EMA to issue scientific advice in a harmonized timeframe with the US Food and Drug Administration.
  • Small and Medium-Sized Enterprises are eligible for fee reductions from EMA.

Read more:

EMA - Guidance for companies requesting scientific advice

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