Publication date: January 14, 2025

Introduction

Super generics, often referred to as hybrid medicines in the European Union (EU) and complex generics in the United States (US), represent an important and growing category of pharmaceutical products. These medicines generally share a similar active substance with an already authorized product but differ significantly in their formulation, strength, route of administration, or indications. Such differences introduce additional value, enhancing therapeutic outcomes or addressing patient needs that existing generics may not fully meet.

In the EU, hybrid medicines are regulated through the European Medicines Agency (EMA). The hybrid application pathway is used for products that demonstrate therapeutic improvements over the reference medicine. This could include differences in dosage forms or additional indications, but the active substance remains the same. Hybrid medicines must meet the standard regulatory requirements for generics while demonstrating clinical efficacy and safety improvements related to the innovation. The EMA’s scientific assessment is central to determining whether the added value is sufficient to justify market approval.

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Publication date: January 09, 2025

A biosimilar is a medicine that is similar to another biological medicine that is already on the market in different countries of the European Union. A medicine that is close in similarity is a medicine that has only minor differences compared to another biological medicine that is already on the market. The term “Biosimilar” is used in the European Union and refers to the comparability between a biologically similar medicine and its reference medicine. Biosimilar medicines are made from living organisms and are used when a serious disease such as cancer occurs.

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Publication date: January 08, 2025

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).

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Publication date: January 03, 2025

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.

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Publication date: December 09, 2024

Introduction to the considerations

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.

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