Analysis of the activity of the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products in the field of clinical trials, registration of medicinal products and monitoring of adverse drug reactions in 2017-2021

Abstract

The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (ORMP) is the state registration authority that grants the marketing authorization for medicinal products on the pharmaceutical market in Poland. ORMP is also involved in approving and controlling clinical trials and in safety of pharmacotherapy (pharmacovigilance) by collecting and analysing reports of adverse drug reactions (ADR). The aim of the study was to review the activity of ORMP in the field of 3 basic competences of this authority: clinical trials, registration of medicinal products and pharmacovigilance in the last 5 years. The evaluation was carried out by the method of document analysis on the basis of data contained in annual bulletins of medicinal products for the years 2017-2021 published by ORMP. In 2017-2021, an increasing trend of clinical trials submitted to ORMP was observed, and they were mainly in phase II and III. Most of the medicinal products introduced to the Polish pharmaceutical market in 2017-2021 were drugs prescribed by a doctor, registered in a decentralized procedure, used in diseases of the nervous and cardiovascular systems and in the treatment of cancer. A relatively low activity of ORMP in monitoring the safety of pharmacotherapy was demonstrated, which was a consequence of low activity of medical staff in the spontaneous ADR reporting. The conducted analysis confirmed the key role of ORMP in surveillance of clinical trials and introducing new medicinal products to the pharmaceutical market in Poland but also indicated the need for increased activity in the area of pharmacovigilance.