Informal Regulatory Guidance

Informal Regulatory Guidance

The Finnish Medicines Agency Fimea provides, at a case-by-case decision to a written request, Informal Regulatory Guidance at an early stage of drug development for clients without sufficient experience of regulatory requirements of drug development.

The discussions may relate to planned or implemented studies and reports or regulatory guidelines. Fimea does not issue precedents or assessments of the adequacy of data that will be or has been produced for the purpose of receiving marketing authorisation. Advice given will not be binding on Fimea or the client. The meeting is free of charge.

Informal Regulatory Guidance meeting is usually held as an online meeting.

Seeking of Informal Regulatory Guidance and Contacts

Please send requests for advice and other contact requests to: [email protected]

Security mail for confidential materials (Instructions for using the secure mail service can be found under the question mark symbol in the service.)

Include the following information and reports to your free-form request for advice:

  • Applicant (company, organisation, academic group etc.)
  • Contact person(s) and contact information
  • Details of advice sought from other authorities concerning the project and details of any clinical studies conducted in Finland
  • A brief background on both the planned or early-stage development project and the intended indication for the product 
  • A description of the need for advice or the topic of discussion
  • Copy of possible bibliographical references
  • The applicant’s possible preference for the timing of the meeting.

Fimea will inform the applicant in writing of the acceptance or rejection of the request. If the request is accepted, Fimea will propose a meeting date. The applicant is requested to submit a presentation of the drug development project (preferably in PowerPoint format) no later than one week prior to the agreed meeting. In addition, the applicant is requested to send the minutes of the meeting to Fimea within two weeks. If needed, Fimea will provide its comments to the minutes within two weeks.