The Coherency of Regulatory Requirements for Homeopathic Medicinal Products in the EU and the EAEU

Abstract Background. In an attempt to stop the distribution of falsified medicinal products, the EU has adopted Directive 2011/62/EU. Since 9th February 2019, each package of medicinal product must be given a unique number in combination with a mandatory indicator of integrity. The Directive requires the creation of a system of serialization and verification of the medicinal products. Aim of the study: To determine the level of awareness about the serialization and verification system among masters of pharmacy and the preparedness of Bulgarian pharmacies to meet the new challenges. Materials and methods: A pilot survey was conducted in 25 pharmacies in Sofia. 41 specialists in pharmacy holding a master degree were interviewed using the “direct individual survey” method. Results and discussion: The knowledge about the availability of new regulatory requirements is in serious dissonance with the established high level of non-awareness of the forthcoming initiatives. Over 2/3 (78%) of the respondents do not know what the practical challenges to their pharmacy practices will be.

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Regulatory Requirements for the Quality of Allergen Products for Allergen Immunotherapy of Food Allergy

Current Allergy and Asthma Reports ◽

10.1007/s11882-021-01008-9 ◽

2021 ◽

Vol 21 (5) ◽

Author(s):

Lisa Englert ◽

Vera Mahler ◽

Andreas Bonertz

Keyword(s):

Allergen Immunotherapy ◽

Major Allergen ◽

Food Allergies ◽

Manufacturing Processes ◽

Critical Element ◽

Medicinal Products ◽

Regulatory Requirements ◽

Quality Aspects ◽

Allergenic Activity ◽

Recent Developments

Abstract Purpose of Review Medicinal products for allergen immunotherapy (AIT) of food allergies have gained enormous momentum in recent years. With this new class of products entering marketing authorization procedures, compliance to regulatory requirements becomes a critical element. Here, an overview is provided on specific requirements and aspects concerning the quality control and manufacturing of these products. Recent Findings Recent developments in the field of AIT for food allergies are divers, including products for oral, epicutaneous, and subcutaneous application, most notably targeting egg, milk, and peanut allergy. As the source materials for food AIT product are typically produced for food consumption and not for medicinal purposes, unique challenges arise in the manufacturing processes and controls of these medicinal products. Individual approaches are needed to assure acceptable quality, including control of relevant quantitative and qualitative characteristics. Major characteristics for quality verification include determination of protein content, total allergenic activity, and major allergen content. The applied manufacturing processes need to be established such that relevant process parameters are kept within justified limits and consistency of produced batches is assured. Summary Allergen products for food AIT present specific challenges with respect to quality aspects that differentiate them from other commonly available AIT products. While established regulation is available and provides clear guidance for most aspects, other issues require consideration of new and individual settings relevant here. Consequently, as experience grows, respective amendments to currently available guidance may be needed.

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Identification of Cost-Optimal Measures for Energy Renovation of Thermal Envelopes in Different Types of Public School Buildings in the City of Valencia

Applied Sciences ◽

10.3390/app11115108 ◽

2021 ◽

Vol 11 (11) ◽

pp. 5108

Author(s):

María Esther Liébana-Durán ◽

Begoña Serrano-Lanzarote ◽

Leticia Ortega-Madrigal

Keyword(s):

Public Schools ◽

Energy Consumption ◽

Public Administration ◽

School Buildings ◽

Regulatory Requirements ◽

Building Stock ◽

Eu Directive ◽

Global Cost ◽

The City ◽

The Eu

In order to achieve the EU emission reduction goals, it is essential to renovate the building stock, by improving energy efficiency and promoting total decarbonisation. According to the 2018/844/EU Directive, 3% of Public Administration buildings should be renovated every year. So as to identify the measures to be applied in those buildings and obtain the greatest reduction in energy consumption at the lowest cost, the Directive 2010/31/EU proposed a cost-optimisation-based methodology. The implementation of this allowed to carry out studies in detail in actual scenarios for the energy renovation of thermal envelopes of public schools in the city of Valencia. First, primary school buildings were analysed and classified into three representative types. For each type, 21 sets of measures for improving building thermal envelopes were proposed, considering the global cost, in order to learn about the savings obtained, the repayment term for the investment made, the percentage reduction in energy consumption and the level of compliance with regulatory requirements. The result and conclusions will help Public Administration in Valencia to draw up an energy renovation plan for public building schools in the city.

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Redundant trials can be prevented, if the EU clinical trial regulation is applied duly

BMC Medical Ethics ◽

10.1186/s12910-020-00536-9 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Daria Kim ◽

Joerg Hasford

Keyword(s):

Clinical Trials ◽

Health Risks ◽

Ethics Committees ◽

Medical Community ◽

Significant Extent ◽

Regulatory Requirements ◽

Trial Participants ◽

Clinical Trials Regulation ◽

Clinical Trial Regulation ◽

The Eu

Abstract The problem of wasteful clinical trials has been debated relentlessly in the medical community. To a significant extent, it is attributed to redundant trials – studies that are carried out to address questions, which can be answered satisfactorily on the basis of existing knowledge and accessible evidence from prior research. This article presents the first evaluation of the potential of the EU Clinical Trials Regulation 536/2014, which entered into force in 2014 but is expected to become applicable at the end of 2021, to prevent such trials. Having reviewed provisions related to the trial authorisation, we propose how certain regulatory requirements for the assessment of trial applications can and should be interpreted and applied by national research ethics committees and other relevant authorities in order to avoid redundant trials and, most importantly, preclude the unnecessary recruitment of trial participants and their unjustified exposure to health risks.

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Regulatory requirements for clinical trial and marketing authorisation application for cell-based medicinal products

Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz ◽

10.1007/s00103-009-0991-5 ◽

2009 ◽

Vol 53 (1) ◽

pp. 24-29 ◽

Cited By ~ 7

Author(s):

P. Salmikangas ◽

E. Flory ◽

J. Reinhardt ◽

T. Hinz ◽

R. Maciulaitis

Keyword(s):

Clinical Trial ◽

Marketing Authorisation ◽

Medicinal Products ◽

Regulatory Requirements ◽

Marketing Authorisation Application

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

Scientific Messenger of LNU of Veterinary Medicine and Biotechnology ◽

10.32718/nvlvet10019 ◽

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.

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More medicines for children: impact of the EU paediatric regulation

Archives of Disease in Childhood ◽

10.1136/archdischild-2017-313309 ◽

2018 ◽

Vol 103 (6) ◽

pp. 557-564 ◽

Cited By ~ 9

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.

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Fundamental review of the trading book: state of art on implementation of Standardised Approach

Risk Management Magazine ◽

10.47473/2020rmm0087 ◽

2021 ◽

Vol 16 (2) ◽

pp. 10-20

Author(s):

Nicoletta Figurelli ◽

◽

Carlo Frazzei ◽

Alessandro Garufi ◽

Tommaso Giordani ◽

...

Keyword(s):

Risk Management ◽

Best Practices ◽

Financial Institutions ◽

Regulatory Framework ◽

Regulatory Requirements ◽

Basel Committee ◽

Key Points ◽

Front Office ◽

State Of Art ◽

The Eu

Following the publication of the regulatory framework for the Fundamental Review of the Trading Book (FRTB) by both the Basel Committee (BCBS) and the EU Regulator, the Financial Institutions have started the mandatory actions to comply with the new regulatory requirements. This article aims to provide an overview of the key challenges that banks have had to face in recent years, with a particular focus on the most significant methodological key points and the main impacts on business from the technicalities of the new regulatory framework, in order to provide guidelines and best practices on Standardized Approach (SA) topics shared between Risk Management and Front Office

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Regulatory exclusivities for medicinal products for human use in the EU

Pharmaceutical Patent Analyst ◽

10.4155/ppa.15.35 ◽

2016 ◽

Vol 5 (1) ◽

pp. 5-8

Author(s):

Carla Schoonderbeek ◽

Bart Jong

Keyword(s):

Medicinal Products ◽

Human Use ◽

The Eu

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Comparison of Regulatory Requirements for Pharmaceuticals in Non- European Union Member States Kosovo, Ukraine and Serbia

Applied Clinical Research Clinical Trials and Regulatory Affairs ◽

10.2174/2213476x06666190624152156 ◽

2020 ◽

Vol 7 (1) ◽

pp. 37-44

Author(s):

Shivani Jani ◽

Nilesh Patel ◽

Urvi Chotaliya ◽

Ashok Patel

Keyword(s):

European Union ◽

Union Member ◽

Regulatory Requirements ◽

Member States ◽

Registration Process ◽

Eu Membership ◽

Regulatory Guidelines ◽

Small Countries ◽

European Union Member States ◽

The Eu

Background: Literature review suggested that regulatory guidelines should be harmonized for better processing of applications and for the upliftment of the regulatory field. Therefore it was thought worthwhile to compare the guidelines for countries where there is requirement of harmonization. Kosovo, Ukraine and Serbia were selected because of being European countries and still they are not a part of EU. Introduction: Kosovo, Ukraine and Serbia are small countries of Europe but they are not members of European Union. They have their own guidelines for the submission of MAA for marketing of pharmaceuticals and medical devices. They are trying to obtain the EU membership and therefore it was worthwhile to compare the guidelines of these countries. Method: The registration process of pharmaceuticals in Kosovo, Ukraine and Serbia was studied throughly. Along with it, the guidelines for European Union were also studied. A comparison of guidelines of all the three countries with the guidelines of European Union for pharmaceuticals was carried out. Result: The comparison of guidelines showed that there are still some changes needed in the guidelines of Kosovo, Ukraine and Serbia before they can merge with the guidelines of European Union. Some of the points in the guidelines are very different from the guidelines of EU. Conclusion: So it was worthwile to study the regulatory requirements of pharmaceuticals in Non- European Union Member States Kosovo, Ukraine and Serbia.

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