Don't PASS the non-interventional study

Don't PASS the non-interventional study

Poster

Mihail Petrov, Svetoslava Handzhieva
Bulgarian Drug Agency

А non-interventional study (NIS) is conducted with an authorised medicinal product in the Republic of Bulgaria, aiming to obtain additional information about this medicinal product. The medicinal product concerned is prescribed in the usual manner in accordance with the terms of the marketing authorisation. The majority of the NISs are post-authorisation safety studies (PASS) - meaning any study relating to an authorised medicinal product conducted with the aim of identifying, characterising or quantifying a safety hazard, confirming the safety profile of the medicinal product, or of measuring the effectiveness of risk management measures. PASS can be initiated voluntarily by the marketing authorisation holder or it can be conducted as a specific obligation/condition to the marketing authorisation. This also determines the difference in the regulatory path of the respective study. For the conduction of a non-interventional PASS in the Republic of Bulgaria, being a condition to the centralized marketing authorisation of the medical product, and which is planned to be conducted in Bulgaria and in other EU member states, the favourable opinion of The Ethics Committee for Clinical Trials and the approval of the study protocol by the Pharmacovigilance Risk Assessment Committee are required. Voluntarily initiated PASS requires permission from the Executive Director of the BDA in addition to the Ethics Committee favourable opinion. Appropriate NIS design, with the impact of confounding factors minimised, can pave the way to collection of reliable real world data for taking regulatory decisions on the safety and efficacy of medicinal products.
Keywords: non-interventional, study, safety, post-marketing