Publication date: March 31, 2025
The healthcare sector is one of the most challenging areas of innovation, characterized by high complexity, strict regulations, high development costs and cultural diversity in different countries. Despite technological progress, fragmentation of innovation ecosystems in digital health is a significant barrier to effective cooperation and implementation of new solutions. The COHES.io project (Connected Health Ecosystems via Open Innovation), which aims to create an interregional space for open innovation in digital health, is the response to these challenges.
More
Publication date: March 31, 2025
In recent years, there has probably been no more dynamically developing market sector than that closely related to the production of drugs, their testing and introduction to consumer circulation. Especially during the COVID-19 pandemic caused by the SARS-CoV-2 coronavirus, all the efforts of pharmacists around the world have been focused on developing an effective formula for a vaccine protecting against infection with this disease, producing it, testing it and making it available to people, and in the longer term on developing a formula for a drug that could be widely used, e.g. in hospitals. No less important at that time were the problems and legal issues related to obtaining permission to produce drugs. In this article, there will be discussed detailed regulations related to the procedure for obtaining consent to manufacture drugs, which is regulated in the Act of 6 September 2001 – Pharmaceutical Law (Journal of Laws of 2024, item 686; amended: Journal of Laws of 2025, item 129), as well as to present the requirements imposed on drug factories in terms of building equipment and production principles, which are regulated in other sub-statutory legal acts.
More
The limits of trade in medicinal products in Poland are strictly defined by legal regulations. The main source regulating the sale of medicines is the Act of 6 September 2001 – Pharmaceutical Law (Journal of Laws of 2024, item 686, as amended) (hereinafter referred to as “Pharmaceutical Law”). Art. 2, point 32 of the aforementioned Act states that a medicinal product is a substance or mixture of substances presented as having properties for the prevention or treatment of diseases occurring in humans or animals or administered for the purpose of making a diagnosis or for the purpose of restoring, improving or modifying the physiological functions of the body through pharmacological, immunological or metabolic action. Pharmaceutical Law presents principles that define the rules of trade in such products.
More
Publication date: March 05, 2025
Methods of transporting medical samples
Transport of medical samples is an essential element of the laboratory diagnostics process, the primary goal of which is to ensure the integrity, stability and quality of biological material at every stage of its movement – from the moment of collection to analysis in the laboratory. Properly organized transport minimizes the risk of sample degradation, contamination, loss of their diagnostic value and potential biological threats to medical personnel and the environment. In addition, precise adherence to transport standards, including appropriate temperature conditions, delivery time and compliance with applicable regulations and procedures, is crucial for obtaining reliable laboratory test results. Below are the main methods of securing medical samples by suppliers during transport.
More
Publication date: March 05, 2025
The AI Act is a regulation adopted by the European Union regulating the use of artificial intelligence in various sectors of the economy, including health, finance and public administration. It is a groundbreaking legal act in this matter. The AI Act has a particular impact on the life science sector, as companies related to the medical industry are increasingly using artificial intelligence in biomedical research, diagnostics and the development of new therapies. The regulation introduces new regulations that entities related to the life science sector are required to implement by August 2026.
The regulation must be complied with by both EU and non-EU entities if they introduce or use AI systems on the EU market (Article 2 (c) AI Act ). Importantly, AI systems used solely for research, innovation, non-professional activities, national security, defence and military purposes are not subject to AI ACT regulations.
Regulatory context
More
