Dissemination of impartial and up-to-date information on all medicines available to patients in the EU through electronic channels
The European medical market currently offers many substances with various medicinal properties, coming from many sources, often purchased from foreign distributors. Medicines are imported by the Member States of the European Union depending on the demand. Due to the multitude and variety of substances available on the medical market, in order to ensure consumer safety, it is necessary to provide access to comprehensive information on the substance admitted to the market, its properties, effects and possible side effects. Both the persons responsible for dispensing the medicine and the consumers purchasing them should have such knowledge.
The European Medicines Regulatory Network has adopted a common standard for electronic product information (ePI) on medicines in the European Union, the initiative aims to provide better and wider access to the database containing data on a specific medicinal substance. The information made available via electronic channels is primarily to be reliable, up-to-date and available to all interested parties. The establishment of common EPI standards in the European Union will streamline the process of providing and updating information provided to patients, consumers and healthcare professionals, thanks to which decisions regarding the consumption of a given substance will be more informed.
One might venture to say that no matter where you were on the Earth, you would most likely have a problem with your energy source and electricity. If you were lucky enough to have it, it would probably be too pricy, harmful to the environment, or unstable. As a society, we face a myriad of problems linked to energy and its distribution, e.g. climate change, energy transition, inequality in distribution, blackouts and political abuse. Nowadays, as the whole World is on a verge of an energy crisis, these problems and questions strike even more.
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 aregulation 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.
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.
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.