THE EU REGULATORY FRAMEWORK FOR MEDICINAL PRODUCTS FOR HUMAN USE

2019 ◽  
pp. 503-551
Author(s):  
Marc Martens
Keyword(s):  
Regulatory Framework ◽  
Medicinal Products ◽  
Human Use ◽  
The Eu

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 Emerging Radionuclides in a Regulatory Framework for Medicinal Products – How Do They Fit?

2021 ◽  
Vol 8 ◽  
Author(s):  
Clemens Decristoforo ◽  
Oliver Neels ◽  
Marianne Patt
Keyword(s):  
Clinical Research ◽  
Copper Chloride ◽  
Regulatory Framework ◽  
Regulatory Environment ◽  
Medicinal Products ◽  
Slowing Down ◽  
Eu Directive ◽  
Formal Requirement ◽  
Theranostic Applications ◽  
The Eu

Recent years have seen the establishment of several radionuclides as medicinal products in particular in the setting of theranostics and PET. [177Lu]Lutetium Chloride or [64Cu]Copper Chloride have received marketing authorization as radionuclide precursor, [68Ga]Gallium Chloride has received regulatory approval in the form of different 68Ge/68Ga generators. This is a formal requirement by the EU directive 2001/83, even though for some of these radionuclide precursors no licensed kit is available that can be combined to obtain a final radiopharmaceuticals, as it is the case for Technetium-99m. In view of several highly promising, especially metallic radionuclides for theranostic applications in a wider sense, the strict regulatory environment poses the risk of slowing down development, in particular for radionuclide producers that want to provide innovative radionuclides for clinical research purposes, which is the basis for their further establishment. In this paper we address the regulatory framework for novel radionuclides within the EU, the current challenges in particular related to clinical translation and potential options to support translational development within Europe and worldwide.

Exploratory assessment of the current EU regulatory framework for development of advanced therapies

1969 ◽  
Vol 16 (4) ◽  
Author(s):  
Pawanbir Singh ◽  
Laure Brévignon-Dodin ◽  
Satya P Dash
Keyword(s):  
Regenerative Medicine ◽  
Research And Development ◽  
Regulatory Framework ◽  
Medicinal Products ◽  
Advanced Therapy Medicinal Products ◽  
Regulatory Strategy ◽  
Technology Changes ◽  
Advanced Therapy ◽  
Advanced Therapies ◽  
The Eu

The Advanced Therapy Medicinal Products (ATMP) Regulation provides a necessary regulatory framework for the commercialisation and use of regenerative medicine-based therapeutic products in the EU. However, concerns have been raised about the appropriateness of the regulatory strategy it has adopted to address different, complex and evolving categories of medicinal products. This article explores some of the potential shortfalls of the ATMP Regulation with regard to facilitating the research and development of advanced therapies in the present and in the future. It concludes that while providing a much needed harmonised regulatory framework for the companies operating in the sector, the new regulation has yet to demonstrate its capacity to keep up with radical technology changes.

scholarly journals THE APPLICATION OF THE PERSONAL IDENTIFICATIONAL NUMBER FOR EU CITIZENS RESIDING IN THE REPUBLIC OF BULGARIA - PRACTICAL ASPECTS

2020 ◽  
Author(s):  
Michal Stojanov ◽  
Keyword(s):  
Legal Framework ◽  
Regulatory Framework ◽  
Administrative Services ◽  
The Republic ◽  
The Eu

Bulgaria's membership in the EU is accompanied by the formation of innumerable bene-fits and commitments that the country receives as inevitable effects of its integration. Participa-tion in the EU is a prerequisite for improvement and supranational unification in the regulation of certain elements in the national legal framework and in the organization of administrative services in the country. However, for more than a decade there have been areas in which the established regulatory framework is not adequately reflected in the work of the Bulgarian ad-ministrative structures. The paper examines the application of the identifier Personal Number for EU citizens permanently residing in the Republic of Bulgaria, where it is found that it is insuffi-ciently applied, which results in bad practices and practical difficulties.

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.

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