Non-interventional studies („Anwendungsbeobachtungen“, post-authorisation safety studies)
According to Article 2 (2) (4) of Regulation (EU) No. 536/2014, a non-interventional study means a clinical study other than a clinical trial. Non-interventional studies are observational studies. No additional diagnostic or monitoring procedures, i.e. beyond normal clinical practice, may be requested for the patient in the observation plan. In non-interventional studies, the drug treatment is in line with normal clinical practice. Therefore, the medicinal products must be authorised and used in accordance with the conditions of the marketing authorisation.
When conducting non-interventional studies in Germany, notification obligations apply to the competent higher federal authority for „Anwendungsbeobachtungen“ and non-interventional post-authorisation safety studies.
„Anwendungsbeobachtungen“ (AWB) are tests that serve the purpose of gathering knowledge resulting from the use of authorised or registered medicinal products, e.g. information on safety and efficacy, but also on the evaluation of pharmacoeconomic aspects, on the care process during treatment with medicinal products or the assessment of patient satisfaction and quality of life.
A post-authorisation safety study (PASS) is any study of an authorised medicinal product that is conducted to identify, characterise or quantify a safety risk, to confirm a medicinal product’s safety profile or to measure the effectiveness of risk management measures.
A notification portal is available to fulfil the legal obligation to notify the above-mentioned studies to the competent higher federal authority.
Further information on the notification of non-interventional studies are available on the website of the Federal Institute for Drugs and Medical Devices (BfArM) or the Paul-Ehrlich-Institut (Federal Institute for Vaccines and Biomedicines, PEI).
According to section 67 subsection 6 sentence 10 of the German Medicinal Products Act, the higher federal authorities are obliged to make the notifications received and the final reports available to the public through an internet portal.