{"entity":{"id":"urpl","kind":"institution","name":"Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL)","aka":["Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych","URPL","URPLWMiPB"],"tldr":"Poland's medicines regulator. New cancer medicines are almost all authorised once for the whole European Union, so its main national roles for cancer patients are authorising clinical trials and watching medicines' safety.","summary":"The Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych registers medicines, medical devices and biocides in Poland and collects reports of side effects. New active substances for cancer must go through the European Union's centralised procedure, in which the European Commission authorises a medicine for every member state on the opinion of the European Medicines Agency, so they are valid in Poland without a separate national approval; the office posts reports of the EU coordination group (CMDh) meetings it attends.\n\nFor clinical trials, the 2023 act on clinical trials of medicinal products, which applies the EU clinical trials regulation, makes the President of the office the authority that decides on trial applications in Poland, with the ethical assessment done by the National Bioethics Committee at the Medical Research Agency or by an accredited local committee. The same act set up a compensation fund for trial participants, administered by the Patient Ombudsman. The office did not publish, on the pages read for this record, a count of trials authorised in recent years or national approval times.","asOf":"2026-11-04","links":[{"label":"URPL","url":"https://www.gov.pl/web/urpl"},{"label":"EMA: authorisation of medicines, scope of the centralised procedure","url":"https://www.ema.europa.eu/en/about-us/what-we-do/authorisation-medicines"},{"label":"Ustawa o badaniach klinicznych produktów leczniczych, Dz.U. 2023 poz. 605 (PDF)","url":"https://api.sejm.gov.pl/eli/acts/DU/2023/605/text.pdf"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":["ema","abm-poland"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"city":"Warsaw","country":"PL","lat":52.21,"lng":20.953,"institutionType":"government","website":"https://www.gov.pl/web/urpl","programs":["Marketing authorisation (national, decentralised and mutual recognition procedures)","Clinical trial authorisation under the EU clinical trials regulation","Pharmacovigilance and side-effect reporting"]},"route":"/institutions/urpl/","neighbours":{"institution":[{"id":"aotmit","kind":"institution","name":"Agency for Health Technology Assessment and Tariff System (AOTMiT)","route":"/institutions/aotmit/"},{"id":"ema","kind":"institution","name":"European Medicines Agency","route":"/institutions/ema/"},{"id":"abm-poland","kind":"institution","name":"Medical Research Agency of Poland (Agencja Badań Medycznych)","route":"/institutions/abm-poland/"}]}}