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 is usually given at a meeting held at Fimea's premises.
Seeking of Informal Regulatory Guidance and Contacts
Please send requests for advice and other contact requests to: firstname.lastname@example.org
Include the following information and reports to your free-form request for advice:
- Contact person(s)
- Details of advice sought from other authorities and details of any clinical studies conducted in Finland
- A brief description of the case or possible problem
- Sufficient background information to select experts for discussions
- Copy of bibliographical references
- Suggested time and participants of the meeting, given no later than two weeks before the suggested date.
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 the minutes of the meeting to Fimea preferably within two weeks. If needed, Fimea will provide its comments to the minutes within two weeks.