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 Thanks to product testing and notifications in the RASFF system, non-compliant products posing a risk to humans are withdrawn from the market.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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Publication date: November 13, 2024
New labelling requirements for medical cannabis as pharmaceutical raw material
Introduction
On 1 July 2024, a new European Pharmacopoeia monograph, Cannabis flos (3028), entered into force. This involves introducing changes to the registration dossiers for pharmaceutical raw materials based on hemp other than fibrous hemp.
Legal basis
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Publication date: November 07, 2024
EU AND POLISH PERSPECTIVE
The role of Polish Agency for Health Technology Assessment and related reimbursement of medicinal products
1. Introduction
In December 2021, Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (OJ EU L 458, 2021, p. 1; hereinafter referred to as the Joint Clinical Assessment Regulation or the Regulation) was adopted. In turn, less than half a year ago, Commission Implementing Regulation (EU) 2024/1381 of 23 May 2024 was adopted, establishing, in accordance with Regulation (EU) 2021/2282 on health technology assessment, procedural rules on interactions during the preparation and updating of joint clinical assessments, the exchange of information on the preparation and updating of joint clinical assessments and the participation in the preparation and updating at Union level of joint clinical assessments for medicinal products for human use, and establishing document templates for those joint clinical assessments (OJ EU L 2024; hereinafter referred to as the Implementing Regulation).
Both of these regulations will soon become legally binding, which will lead to fundamental changes in the pharmaceutical market of the European Union Member States, including Poland. A joint clinical assessment will be introduced, as a result of which the clinical assessment of medicines and medical devices introduced to the Polish market will no longer be carried out at the national administration level by the Agency for Health Technology Assessment and Tariff System.
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