On January 31, 2022, the Regulation of the European Parliament and the Council of the European Union on clinical trials of medicinal products for human use came into force, repealing Directive 2001/20/EC at the same time.
What the CTR actually is?
The Clinical Trials Regulation is a regulation containing provisions on clinical trials. To better understand the whole problem, it is necessary to consider what they are and what aspects clinical trials contain.
“Clinical trial” means a clinical study – any investigation in relation to humans intended to discover or verify effects of one or more medicinal products, to determine safety and effectiveness of those medicinal products. The former concept of clinical trial needed to be clarified by introducing a broader concept of biomedical research. The issue of the terms introduced in the Regulation will be discussed in more detail at the end of the article.
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May 7, 2022 marked the introduction of the amendment to the Polish Act on Counteracting Drug Addiction. The amendments to the Polish regulations make it possible to cultivate non-fiber hemp, carried out in research institutes, in order to obtain the raw material intended for the preparation of drugs. The act also transfers the obligation to monitor the cultivation of poppy and fibrous hemp from local government authorities to the National Center for Agricultural Support.
The cultivation of hemp and poppy seeds in Poland is a controlled sector. The current legal status contains regulations according to which the producer and the buyer of poppy or hemp annually submitted an application, together with all the documentation, to the relevant authorities (mayors, city presidents) or voivodeship marshals for a decision authorizing the cultivation or purchase of poppy or fiber hemp. The new solutions abolish these requirements. To be able to grow hemp or poppy, one will only need to submit an application to the National Center for Agricultural Support. Additionally, on the basis of the current regulations, the voivodship parliament is responsible for determining the area of poppy and hemp. This solution had a limiting effect on the cultivation area and the development opportunities of the national bioeconomy. The new regulations abolish this obligation. In addition, the catalog of destination and purposes for which poppy or industrial hemp can be used is to be expanded.
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From May 1, 2022 in Poland adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after at least two lines of systemic treatment will receive funding for the novel CAR-T (tisagenlecleucel) therapy.
CAR-T is a breakthrough in the treatment of hematology patients. The mechanism of action of this therapy is completely different from the drugs used so far. Individualized CAR-T therapy uses the patient’s immune system. The patient’s T lymphocytes are collected and modified outside the body, thanks to which they are able to recognize cancer cells expressing a specific antigen and fight them.
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What are generic drugs?
Patent protection for a newly introduced drug on the market lasts almost 20 years. During this time, no other company (except the one with the patent) has the right to produce it. When protection ends, the drug may be manufactured by other manufacturers who begin to compete with each other – such competing drugs are called generics.
The original and generic medicine may differ in name, manufacturer and price. However, the active substance contained in them, which is responsible for the action of the drug, and its amount will always be the same. Thanks to the guarantee of equally high production standards and constant monitoring of safety and effectiveness, patients can freely choose the product that best suits them in the pharmacy. The manufacturing process of generic drugs must follow the principles of Good Manufacturing Practice (GMP). Compliance with the GMP rules allows for the provision of good quality medical devices.
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KIELTYKA GLADKOWSKI KG LEGAL takes part in the project “Systemic Design and Sustainable Healthcare for MedTech Manufacturing (SysteMA)”. One of elements of the project is led by the Life Science Cluster in Krakow and the MedSilesia cluster. The latter became involved in activities to raise awareness and knowledge in the field of the circular economy.
The research is part of the EIT Manufacturing project SysteMA (Systemic Design and Sustainable Healthcare for MedTech Manufacturing), which focuses on the role of MedTech manufacturing towards the environmental, social, and economic sustainability of healthcare systems. The project aims to create online training courses on this topic, providing EU companies with actionable skills to improve the sustainability of their products and processes and seize new market opportunities.
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