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 Thanks to product testing and notifications in the RASFF system, non-compliant products posing a risk to humans are withdrawn from the market.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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Publication date: November 14, 2024
Article 45 paragraph 2 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) in addition to the type of information included in the scope of labelling also specifies the media on which this information is provided. It includes both information media that are physically connected with the foodstuff (packaging, label, jacket, leaflet, tag, attached documents) and documents related to the product, but not necessarily directly attached to it (e.g. commercial documents, product specifications transferred in the course of trade between entrepreneurs). Such a broad scope of labelling differs from the traditionally understood labelling of goods, which covers only the information placed on the product itself, its packaging or label. Therefore, product labelling means any action, connection of a given information medium, e.g. a label with a product or service, as a result of which a physical connection is established between the specific medium and the product”. [1]
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