POLAND Trends and Developments Contributed by: Barbara Kiełtyka, Jakub Gładkowski and Małgorzata Kiełtyka, Kieltyka Gladkowski KG Legal
Problems Encountered by Foreign Drug Manufacturers Conducting Clinical Trials in Poland Foreign drug manufacturers are very active on the Polish market, testing the effectiveness of their newest drugs for serious and complicated diseases. According to Eurostat, drug creation accounts for up to three-quarters of the drug cycle, and only one in several thousand chemical compounds meets the regulatory and economic conditions for commercialisation and entry into the market as a finished drug product. Clinical trials represent the final phase of drug creation and are critical for validating the many years of effort expended by a drug manufacturer, which usually begins with the formula being covered by patent protection. Poland, as a member of the EU, is subject to the highly restrictive Regulation 536/2024, which regulates the entire process of clinical trials, including the actors therein, super- vision and even IT infrastructure. In the Polish legal system, Regulation 536/2024 is supple- mented primarily by the Pharmaceutical Law, encompassing several thousand implementing acts and the Act of 9 March 2023 on clinical tri- als of medicinal products for human use. Despite the extensive experience of regulatory bodies and the large number of regulations, there is unfortunately no regulation for the release of a drug after a clinical trial if a foreign pharmaceuti- cal company decides not to enter into the sales process (ie, does not commercialise the drug). In Europe, this is referred to as “compassionate use” , which is not regulated in Poland. It is important to anticipate the possibility of not entering the market with a given drug after the completion of a clinical trial given that, in Poland, foreign sponsors have occasionally made refer- ence to very detailed changes in Polish pharma- ceutical law in their clinical trial plans – associ- ated with the introduction of the compassionate
Quality Management System for Medical Devic- es, are important. ISO 13485 specifies the requirements for a quality management system that can be used by organisations engaged in the design, devel- opment, production, installation and servicing of medical devices and the provision of related services. The current EU regulations on medical devices, active implantable medical devices and in vitro diagnostic medical devices, which place greater emphasis on proving efficacy and safety, con- ducting clinical trials and detailed assessment before placing devices on the market, are impor- tant for medical device market participants. The key regulations are Medical Devices Regulation (EU) 2017/745 on medical devices and active implantable medical devices and In Vitro Diag- nostic Medical Devices Regulation 2017/746. The key changes introduced by these regula- tions include: • the introduction of the European Database for Medical Devices (EUDAMED), which facili- tates the tracking of medical devices; • extension of market surveillance and product surveillance (Articles 84–93); • clarification of the roles and responsibilities of economic operators (Articles 10–30); • the introduction of unique device identifica- tion (UDI) codes and implant cards (Articles 18 and 27); • new rules on clinical evaluation and clinical trials (Articles 55–61); and • changes to safety and effectiveness require- ments (Annex I).
230 CHAMBERS.COM
Powered by FlippingBook