Informal Regulatory Guidance
View connections →Informal Regulatory Guidance provides information on regulatory instructions related to drug development
Published by: Fimea · Government organisation
Description language: English
Coverage: All Finland
About this service
Description
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.
Where and how to get help
Informal Regulatory Guidance · Website
Fimea provides, at a case-by-case decision, Informal Regulatory Guidance at an early stage of drug development.
Description: English · Service languages: Swedish, English, Finnish
Check the official service page for current hours, exceptions, identification requirements and further contact details.
Fimea Secure Mail · Online service
Instructions for using the Fimea Security Mail Service
Description: English · Service languages: Swedish, English, Finnish
Check the official service page for current hours, exceptions, identification requirements and further contact details.