Regulatory exclusivities for medicinal products for human use in the EU

2016 ◽  
Vol 5 (1) ◽  
pp. 5-8
Author(s):  
Carla Schoonderbeek ◽  
Bart Jong
Keyword(s):  
Medicinal Products ◽  
Human Use ◽  
The Eu

scholarly journals Reforming of legislation on the residues of veterinary medicinal products in foodstuffs of animal origin as a component of Ukraine food security

2020 ◽  
Vol 22 (100) ◽  
pp. 108-115
Author(s):  
I. Berezovska
Keyword(s):  
Food Security ◽  
Legal Regulation ◽  
Economic Security ◽  
Animal Origin ◽  
The European Union ◽  
Medicinal Products ◽  
Association Agreement ◽  
National Legislation ◽  
The Eu ◽  
Veterinary Medicinal Products

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.

Detection of Effects on Male Reproduction—A Literature Survey

1995 ◽  
Vol 14 (4) ◽  
pp. 293-327 ◽  
Author(s):  
Beate Ulbrich ◽  
Anthony K. Palmer
Keyword(s):  
General Purpose ◽  
Literature Survey ◽  
Optimal Combination ◽  
Male Reproduction ◽  
Medicinal Products ◽  
Sperm Production ◽  
Technical Requirements ◽  
Mating Trial ◽  
Weight Analysis ◽  
Human Use

The 1CH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) Guideline for Detection of Toxicity to Reproduction for Medicinal Products, adopted at the Second ICH Conference in Orlando, FL, U.S.A., emphasized the need for research into the suitability of various methods for the detection of effects on fertility in males. The current project was undertaken to compare the efficiency of methods by evaluating reports in the open literature. The results of the examination of 117 substances or substance classes support the view that histopathology and organ weight analysis provide the best general-purpose means of detecting substances with the potential to affect male fertility. Examinations at up to 4 weeks of treatment appear to be as effective as examinations conducted at later times. Mating with females for detection of effects unrelated to interference with sperm production appears to provide an optimal combination because adding other methodologies does not materially improve the detection rate. As to the timing of the mating trial, a 2-week premating period is as efficient as mating at 4 weeks and apparently more efficient than mating after prolonged premating treatment.

More medicines for children: impact of the EU paediatric regulation

2018 ◽  
Vol 103 (6) ◽  
pp. 557-564 ◽  
Author(s):  
Sofia Nordenmalm ◽  
Paolo Tomasi ◽  
Chrissi Pallidis
Keyword(s):  
Product Information ◽  
Positive Impact ◽  
The European Union ◽  
Medicinal Products ◽  
Paediatric Regulation ◽  
Line Extension ◽  
Pharmaceutical Form ◽  
Paediatric Drug Development ◽  
Medicines For Children ◽  
The Eu

IntroductionThis paper focuses on the authorisation of new medicines, new indications and new pharmaceutical forms or strengths for use in children and also on the availability of paediatric information in the product information of centrally authorised medicinal products following the enforcement of the Paediatric Regulation on 26 January 2007.ObjectivesTo investigate whether the Paediatric Regulation has led to more medicines available for children in the European Union (EU) and if more information on paediatric use is now available in the product information of medicines authorised via the centralised procedure.Materials and methodsWe retrospectively analysed the centrally authorised medicinal products in the EU that had an approval for an initial marketing authorisation, a type II variation, or a line extension during the years 2004–2006 and 2012–2014. Medicinal products not subjected to the obligations of the Paediatric Regulation were excluded.ResultsIn 2004–2006, 20 new medicines and 10 new indications were centrally authorised for paediatric use compared with 26 new medicines and 37 new indications in 2012–2014. The number of medicines with a new pharmaceutical form or strength for use in children was eight in 2004–2006 and seven in 2012–2014. There was a huge increase in the number of products with changes of paediatric relevance in the summary of product characteristics in 2012–2014 compared with 2004–2006.ConclusionsThe entry into force of the Paediatric Regulation has had a positive impact on paediatric drug development with more medicines available for children in the EU and substantially more information available for clinicians on paediatric use in the product information.

The Proposed EU-regulation on Clinical Trials on Medicinal Products: An Unethical Proposal?

2013 ◽  
Vol 20 (4) ◽  
pp. 347-362 ◽  
Author(s):  
Jilles Heringa ◽  
Joseph Dute
Keyword(s):  
Clinical Trials ◽  
Human Subjects ◽  
The European Union ◽  
Medicinal Products ◽  
Member States ◽  
Legal Documents ◽  
Human Use ◽  
Proposed Regulation ◽  
High Level ◽  
Force Member

Abstract The Commission has proposed a regulation ‘on clinical trials on medicinal products for human use’ to introduce one regulatory framework for clinical trials in the European Union. This regulation should replace the current clinical trials directive (2001/20/EC). In this article we describe and critically review the main provisions of the proposed regulation. We assess the consequences for a sound authorisation procedure of clinical trials and the level of protection for human subjects. We note that the proposed regulation is inconsistent with applicable international legal documents, such as the Biomedicine Convention and the Declaration of Helsinki. We conclude that the proposed regulation does not ensure a “high level of human health protection” — required by its legal basis in the TFEU — because it may force Member States concerned to accept a reporting Member States’ approval of — in their estimation — an unethical clinical trial.

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