scholarly journals Registration of Novel Parasiticides under the New 2022 EU Regulation

2021 ◽  
Vol 5 (1) ◽  
pp. 2
Author(s):  
Sabine Richter ◽  
Julia Hunte ◽  
Klaus Hellmann

Twenty-one years after Directive 2001/82/EC regulating veterinary medicinal products (VMPs) came into force, a new veterinary regulation will apply from 28 January 2022. Future applicants will have to follow the requirements of Regulation (EU) 2019/6. This regulation defines different products, non-biologicals (equivalent to formerly defined pharmaceuticals), and biological products. Biological VMPs belong either to the new class, non-immunological VMPs or immunologicals, including those known as vaccines. This new regulation also defines novel therapies covering innovative medicinal therapeutic approaches. Antiparasitic products will always be VMPs, and additional requirements for environmental safety and potential risks for the development of resistance are enforced.

One Health ◽  
2021 ◽  
pp. 100237
Author(s):  
K.L. Mahefarisoa ◽  
N. Simon Delso ◽  
V. Zaninotto ◽  
M.E. Colin ◽  
J.M. Bonmatin

2021 ◽  
Vol 33 (1) ◽  
Author(s):  
Rosemary Perkins ◽  
Martin Whitehead ◽  
Dave Goulson

AbstractAnthe et al. (Environ Sci Eur 32:147, 2020. 10.1186/s12302-020-00424-4) develop a mathematical model to calculate the contribution of veterinary medicinal products (VMPs) to the levels of imidacloprid observed in the UK water monitoring programme. They find that VMPs make only a very small contribution to measured pollution levels, and that the estimated concentrations do not exceed ecotoxicological thresholds. However, shortcomings in methodology—including the implicit assumption that imidacloprid applied to pets is available for release to the environment for 24 h only and failure to incorporate site-specific sewage effluent data relating to measured levels—raise questions about their conclusions. Adjusting for these and other deficiencies, we find that their model appears consistent with the conclusion that emissions from VMPs may greatly exceed ecotoxicological thresholds and contribute substantially to imidacloprid waterway pollution in the UK. However, the model utilises imidacloprid emissions fractions for animals undergoing the different scenarios (for example, bathing) that are extrapolated from unpublished studies that do not clearly resemble the modelled scenarios, with insufficient evidence provided to support their derivation. As a result, we find that the model presented by Anthe et al. provides no reliable conclusions about the contribution of veterinary medicinal products to the levels of imidacloprid in UK waterways.


2014 ◽  
Vol 2014 ◽  
pp. 1-12 ◽  
Author(s):  
Min Kyong Song ◽  
Neal M. Davies ◽  
Basil D. Roufogalis ◽  
Tom Hsun-Wei Huang

Cardiorenal syndrome (CRS) is a complex disease in which the heart and kidney are simultaneously affected and their deleterious declining functions are reinforced in a feedback cycle, with an accelerated progression. Although the coexistence of kidney and heart failure in the same individual carries an extremely bad prognosis, the exact cause of deterioration and the pathophysiological mechanisms underlying the initiation and maintenance of the interaction are complex, multifactorial in nature, and poorly understood. Current therapy includes diuretics, natriuretic hormones, aquaretics (arginine vasopressin antagonists), vasodilators, and inotropes. However, large numbers of patients still develop intractable disease. Moreover, the development of resistance to many standard therapies, such as diuretics and inotropes, has led to an increasing movement toward utilization and development of novel therapies. Herbal and traditional natural medicines may complement or provide an alternative to prevent or delay the progression of CRS. This review provides an analysis of the possible mechanisms and the therapeutic potential of phytotherapeutic medicines for the amelioration of the progression of CRS.


2020 ◽  
Vol 22 (100) ◽  
pp. 108-115
Author(s):  
I. Berezovska

It is known that the food security of the state, aimed at providing the population with quality and healthy food, is an important component of economic security. Recent developments in the world and national security challenges posed by the Covid-19 virus pandemic necessitate a reassessment of approaches to the legal regulation of issues that significantly affect human health. Today, the reform of the relevant national legislation on FAR residues in food requires a systematic and holistic approach and the definition of its priorities in such a way as to promote food safety and the development of domestic business. The article is devoted to the analysis of the current Ukraine legislation concerning regulation of residues of veterinary medicinal products in foodstuffs of animal origin. It was shown that the formation of such legislation was due to the development of international trade, including the fulfilment of the European Union requirements for the safety of foodstuffs imported into its market. At the same time, the conclusion of the Association Agreement and the introduction of a Free trade zone with the EU was a significant impetus to the reforming of national legislation on residues. The analysis of EU regulations, which serves as a legal basis for the residues control at the EU level, was carried out. It is noted that today in the Ukrainian legislation, despite the introduction of annual national plans for state monitoring of residues of veterinary medicinal products and contaminants in live animals and unprocessed foodstuffs of animal origin, there are a number of gaps that require urgent legislative regulation. It was proved that the completion of the reform of the national legislation on residues will contribute to improving safety of domestic foodstuffs, and therefore, will have important positive consequences not only for the development of trade with the EU, but primarily for the food security of Ukraine and the protection of the health of Ukrainian citizens.


Author(s):  
A.R. Peters

Legislation to control veterinary medicinal products is undergoing continual development in the EEC and UK and therefore the risks are continually reassessed. In the present paper current and future legislation together with consumer concerns both real and imaginary are reviewed.Since the EEC ban on hormonal growth promoter implants in 1986 the remaining legal products are all feed additives. Registration of feed additives in the EEC is controlled under Directive 70/524 and its various amending directives. this directive is concerned with all products added to feed and mainly includes substances used to affect the quality of the feedstuff i.e., emulsifiers, stabilisers, antioxidants, colorants and binding agents and also vitamins and micronutrients. The majority of growth promoters exert their affects by antimicrobial activity and these and certain prophylactic medicinal products such as coccidiostats are also included. All products with a therapeutic action are controlled under the Veterinary Medicine Directives 81/851 and 81/852, quite separate legislation and under the responsibility of a different department within the EEC Coimdssion. However, there is provision under Directive 84/587 amending 70/524 to transfer the medicinal feed additives to 81/851 and 81/852.


2012 ◽  
Vol 8 (3) ◽  
pp. 416-418 ◽  
Author(s):  
Michelle G. J. L. Habets ◽  
Michael A. Brockhurst

Antimicrobial peptides (AMPs) have been proposed as a promising new class of antimicrobials despite warnings that therapeutic use could drive the evolution of pathogens resistant to our own immunity peptides. Using experimental evolution, we demonstrate that Staphylococcus aureus rapidly evolved resistance to pexiganan, a drug-candidate for diabetic leg ulcer infections. Evolved resistance was costly in terms of impaired growth rate, but costs-of-resistance were completely ameliorated by compensatory adaptation. Crucially, we show that, in some populations, experimentally evolved resistance to pexiganan provided S. aureus with cross-resistance to human-neutrophil-defensin-1, a key component of the innate immune response to infection. This unintended consequence of therapeutic use could drastically undermine our innate immune system's ability to control and clear microbial infections. Our results therefore highlight grave potential risks of AMP therapies, with implications for their development.


Cells ◽  
2019 ◽  
Vol 8 (1) ◽  
pp. 43 ◽  
Author(s):  
Veronica Mollica ◽  
Vincenzo Di Nunno ◽  
Alessia Cimadamore ◽  
Antonio Lopez-Beltran ◽  
Liang Cheng ◽  
...  

Management of metastatic or advanced prostate cancer has acquired several therapeutic approaches that have drastically changed the course of the disease. In particular due to the high sensitivity of prostate cancer cells to hormone depletion, several agents able to inhibit hormone production or binding to nuclear receptor have been evaluated and adopted in clinical practice. However, despite several hormonal treatments being available nowadays for the management of advanced or metastatic prostate cancer, the natural history of the disease leads inexorably to the development of resistance to hormone inhibition. Findings regarding the mechanisms that drive this process are of particular and increasing interest as these are potentially related to the identification of new targetable pathways and to the development of new drugs able to improve our patients’ clinical outcomes.


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