New broader interpretation on defining the non-interventional trials

Lääketeollisuus ry

The EU clinical trial regulation 536/2014 will harmonise the interpretation of interventional vs non-interventional trials (NIS) in EU but meanwhile Finnish Medicines Agency Fimea has decided to make three changes to the current interpretation to allow more non-interventional trials in Finland on well-defined grounds.

Fimea´s new definition allows for example quality of life and safety related questionnaires and collection of Adverse Event (AE) –data from March 8, 2016.

  1. The treating physician and the investigator can be the same person, on certain conditions:
    • the trial medication is prescribed according to the terms in the Marketing Authorisation,
    • the protocol does not direct the choice of treatment of the patient,
    • the decision how to treat the patient, the choice of medication and decision to recruit the patient into the trial are clearly separated and
    • the treatment is according to normal medical practice.
  2. Quality of life and safety related questionnaires are allowed, but not those related to efficacy
  3. Collecting AE-data is allowed as long as safety reporting is done according to spontaneous adverse drug reporting rules

Pharma Industry Finland has worked in close collaboration with Fimea in preparation of the change, and fully supports Fimea in its’ implementation. These changes will significantly increase the number of non-interventional trials conducted in Finland.