Publication date: December 02, 2024
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
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Publication date: November 29, 2024
According to Food and Drug Administration (FDA), a ‘generic drug’ is the same as a brand name drug in many aspects such as dosage, safety, strength, how it is taken, quality, performance, and intended use. On the other hand, the term supergeneric is applied to the development process for small molecule drugs which represent new therapeutic entities which demonstrate an improvement in either product delivery, design or through the application of a more efficient manufacturing process.
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Publication date: November 21, 2024
The risk analysis should take into account real threats to data processing and properly estimate their level. Risk analysis cannot be a superficial activity performed solely to meet the formal requirements of the personal data protection regulations, because then it does not function as an effective way to minimize threats – learnings from the most current decision of the Polish Office for Personal Data Protection imposing a fine on a medical company undergoing ransomware attack.
Introduction
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Publication date: November 21, 2024
In recent years, artificial intelligence (AI) and machine learning (ML) technology have begun to play an increasingly important role in the pharmaceutical industry. AI offers the potential to revolutionize the way we produce medicines, leading to significant improvements in quality, efficiency, and innovation. However, introducing modern technologies into the regulated pharmaceutical environment is associated with challenges related to ensuring quality and compliance with applicable regulations. It is in this context that GAMP5 (Good Automated Manufacturing Practice) is one of the most important tools for managing the life cycle of computer systems in the pharmaceutical or biopharmaceutical industry, including systems based on AI.
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Publication date: November 14, 2024
Rapid Alert System for Food and Feed (RASFF)
Under Article 50 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 (OJ EU L. of 2002 No. 31, p. 1, as amended), RASFF was established, a system for notifying direct or indirect danger to human health deriving from food or feed. Thanks to product testing and notifications in the RASFF system, non-compliant products posing a risk to humans are withdrawn from the market. Information is entered into the system on food, feed and food contact materials that are potentially dangerous to human health, animals or the environment and follow-up actions as a result of identifying such products. Due to the type of identified threats that appear in the system, RASFF is an important source of information on product safety. Substances are identified in imported products that, if consumed by humans, may cause serious, negative health effects.
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