Undertaking clinical trials plays a fundamental role in the development and marketing authorisation of medicinal products. The aim of clinical trials is to test the safety and effectiveness of the products being studied. A trial sponsor is an individual, company, institution or organisation that is responsible for undertaking, managing and organising the financing of a clinical trial.
Bioethics Commission
The composition and functioning of the bioethics commission are specified in Article 29 of the Act of 5 December 1996 on the professions of physician and dentist (consolidated text: Journal of Laws of 26 March 2018, item 617) and in the Regulation of the Minister of Health of 11 May 1999 on the detailed principles of establishing and financing and the mode of operation of the bioethics commission (Journal of Laws No. 47, item 480).
Dietary supplements with vitamins are subject to regulations contained in the Act of 25 August 2006 on food and nutrition safety. The definition of a dietary supplement is found in Article 3 of the aforementioned Act. A dietary supplement is a food product that is a source of vitamins or minerals or other nutrients, the purpose of which is to supplement the diet. A dietary supplement does not belong to the group of pharmaceutical products but to the group of food products.
In order for a dietary supplement to be placed on the market, it is not required to obtain a certificate. According to Article 29 of the Food and Nutrition Safety Act, the product must be reported to the Chief Sanitary Inspectorate (Polish GIS) at least 14 days before being placed on the market.
The certificates that a plant producing dietary supplements can obtain are the GMP and HACCP certificates.
Artificial intelligence is an invention that is definitely changing the world. One of the most interesting areas of its use is the medical industry. Soon, all pharmaceuticals discovered and produced using AI will be available in pharmacies. This industry is also associated with the use of artificial intelligence for medical products. On the one hand, it is about using it for clinical trials on a specific product, i.e. taking advantage of the AI program to introduce this product to the market faster. On the other hand, it is about authorizing a specific medical product whose operation will be based on the use of AI.
The Human Cell Atlas (HCA) is a groundbreaking global initiative aimed at mapping all human cell types to transform our understanding of health and disease. By creating a detailed reference map of human cells, the HCA is poised to advance medical research, enabling better disease diagnosis, treatment, and prevention. Using cutting-edge technologies like single-cell genomics and spatial analysis, the project is generating vast amounts of data, with global participation from over 3,200 scientists across 99 countries. The HCA’s findings have significant medical implications, including insights into disease mechanisms, personalized therapies, and rapid responses to health crises like the COVID-19 pandemic. Despite its vast potential, the HCA faces challenges, particularly in ensuring global equity and navigating complex ethical and legal issues like data protection and intellectual property. Efforts to create an inclusive, diverse, and open data-sharing platform are crucial, but disparities in infrastructure and knowledge between high-income and low- to middle-income countries remain barriers. Addressing these challenges with robust ethical frameworks, data protection measures, and clear intellectual property guidelines is essential to the HCA’s success. Ultimately, the HCA aims to provide a transformative resource that enhances human health while fostering global collaboration and inclusivity.
The Ministry of Health in Poland has proposed a number of draft laws aimed at combating the sale of electronic cigarettes and heated tobacco products. The new regulations will concern the amendment of the Act of 9 November 1995 on the protection of health against the effects of using tobacco and tobacco products (consolidated text: Journal of Laws of 2024, item 1162), hereinafter referred to as the “Tobacco Act”. The Government Legislation Centre website currently presents draft laws prohibiting the sale of nicotine-free electronic cigarettes to persons under 18 years of age and introducing the definition of a heated tobacco product into the Tobacco Act. The Ministry of Health has also announced a draft law on a complete ban on the sale of disposable cigarettes.
Ban on the sale of electronic cigarettes to persons under 18 years of age and other restrictions
