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This section on health in the EU has been created as a trustworthy gateway to a wide range of information and data on health-related issues and activities at both European, national and international level. The content is produced by the European Commission, the Member States of the EU and the European Economic Area (EEA), plus EU candidate countries; by international organisations; and by pan-European non-governmental organisations in the area of public health.

50th Anniversary International conference    edqm.eu

03 March 2014 50thAnniversary International conference On 6-8 October 2014, the EDQM is organising a landmark international conference to celebrate the 50th anniversary of the Convention on the Elabo[...]

Risk assessment vs risk management: What’s the difference?    europa.eu

Published on: 16 April 2014 The decision to separate the tasks of risk assessment and risk management just over a decade ago has transformed the safety of Europe's food. And while there is wide recog[...]

Call for scientific data for use in HMPC assessment work on Glycine max, lecithin, draft: consultation open    europa.eu

The HMPC invites all interested parties such as pharmaceutical industry associations, health care professional groups, learned societies, consumers and patients' associations, governmental institutio[...]

Stop-the-clock guidelines to improve efficiency and consistency of regulated product assessments    europa.eu

Published on: 14 April 2014 New working practices will increase the efficiency, clarity and consistency of the assessment of regulated product applications, said the European Food Safety Authority (E[...]

Guidelines debate in favour of BCG maintenance    uroweb.org

Audience participation was an integral part of the Guidelines-dedicated Thematic Session 3 where the outcomes of pro and contra debates were revealed through voting. During the session Profs. Richard[...]

Hepatitis A: EFSA and ECDC update their rapid outbreak assessment    europa.eu

Published on: 11 April 2014 More than 1,300 hepatitis A cases have been reported in eleven Member States since January 2013, with 240 confirmed cases related to the ongoing outbreak. Initially the ou[...]

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 April 2014    europa.eu

The Pharmacovigilance Risk Assessment Committee (PRAC) gave a recommendation on one safety review and started four new safety reviews at its April meeting.[...]

Specifications for additional efficacy studies for medicines published in the Official Journal of the EU    europa.eu

The European Commission has adopted a delegated act specifying the situations where a post-authorisation efficacy study can be required by medicines regulatory authorities.[...]

Development and evolution of risk assessment for food allergens    eufic.org

The risk from the unintentional presence of an allergen in a food product must be assessed before it can be managed effectively. Using probabilistic modelling, the risk can be assessed by combining d[...]

Scientific guideline: Draft concept paper on the establishment of a guideline on the selection of sterilisation processes for drug products, draft: consultation open    europa.eu

This concept paper addresses the need for a revision of the guidance on the selection of sterilisation methods currently provided for in the annexes to the (separate) human and veterinary development[...]

Hepatitis C treatment guidelines issued    who.int

WHO has issued its first guidance for the treatment of hepatitis C, a chronic infection that affects an estimated 130 million to 150 million people and results in 350 000 to 500 000 deaths a year wor[...]

Bisphenol A: EFSA to complete re-evaluation by the end of 2014    europa.eu

Published on: 9 April 2014 The European Food Safety Authority (EFSA) is extending the timeline to complete its full risk assessment of bisphenol A (BPA) to the end of 2014. This will give EFSA's scie[...]

President Barroso received representatives of the Group of Eminent Persons of the Atlantic Basin Initiative    europa.eu

European Commission Press release Brussels, 7 April 2014 The President of the European Commission has met ten representatives of the Group of Eminent Persons of the Atlantic Basin Initiative. Among o[...]

EPHA comments on WHO draft guidelines for sugar intake for adults and children    epha.org

At the end of March 2014, EPHA commented on the World Health Organization's (WHO) draft guidelines for sugar intake for adults and children. Put recently for public consideration, the new proposal ai[...]

Pioneering EU project on track to assess level of contaminants in seafood    europa.eu

Pollution of the oceans and climate change has sparked concerns not just about the status of the marine environment but also about the impact on seafood safety and public health. In the global seafoo[...]

148th Session of the European Pharmacopoeia Commission    edqm.eu

04 April 2014 148th Session of the European Pharmacopoeia Commission During its 148th session, the European Pharmacopoeia Commission adopted eight new monographs for inclusion in the European Pharmac[...]

New resources support quality management in laboratories    who.int

To help laboratories implement systems to manage quality control, WHO recently launched a suite of resources in several languages.[...]

Peer review on PES approaches for sustainable activation of long-term unemployed (LTU)    europa.eu

The National Employment agency of Bulgaria will host this peer review from 10-11 April in Sofia, Bulgaria.[...]

Exercise training improves HDL quality in CHF patients    escardio.org

Nicolle Kraenkel comments on a study by V. Adams et al. (Circulation Research, 2013), suggesting that in patients with severe CHF, exercise training achieves a [...]

Final Report Summary - RISK-LESS (Quantitative Vulnerability Assessment for the Evaluation of Landslide Risk in Inhabited Areas)    europa.eumsw8

UNIVERSITAT POLITECNICA DE CATALUNYA This project was focused on the quantification of the vulnerability due to different types of landslides, with the objective of the refinement of the current appr[...]

Food4Me: Protecting the consumer with guidelines for personalised nutrition offerings    eufic.org

In this podcast the work within the Food4Me project in addressing the legal challenges and issues associated with the delivery of personalised nutrition services or advice to the public is discussed,[...]

Certification - Clarification of two rounds of evaluation    edqm.eu

27 March 2014 Certification - Clarification of Policy of Two rounds of Evaluation The Certification Division has published a document on its Policy of Two Rounds of Evaluation for Applications for Ce[...]

Roma integration: EU Roma Summit to evaluate progress    europa.eu

European Commission Press release Brussels, 28 March 2014 Local, national and EU politicians and leaders will gather with civil society in Brussels on 4 April to discuss progress on Roma integration [...]

 EFSA assesses the risk of Salmonella and Norovirus in leafy greens    europa.eu

Published on: 27 March 2014 Rainfall, use of contaminated water for irrigation or contaminated equipment are among the factors that cause contamination of leafy greens with Salmonella and Norovirus. [...]

Knowledge database: new version released    edqm.eu

03 March 2014 Knowledge database: new version released A new version of the Knowledge Database has been released: please read the instructions given under [...]

Development of a new Pan-Europea Paediatric formulary as a complementary contribution to other European activities for ensuring better medicines for children    edqm.eu

14 March 2014 Development of a new Pan-European paediatric formulary initiated as a complementary contribution to other European activities for ensuring better medicines for children The European Com[...]

Trends in Blood Transfusion in Europe: 2001-2008 Report now available    edqm.eu

12 March 2014 Trends in Blood Transfusion in Europe 2001-2008 Report now available This report is the second trend analysis report on the outcomes of the surveys requesting information on the collect[...]

Certification - Clarification of two rounds of evaluation    edqm.eu

27 March 2014 Certification - Clarification of Policy of Two rounds of Evaluation The Certification Division has published a document on its Policy of Two Rounds of Evaluation for Applications for Ce[...]

Joint Statement: Tackling alcohol related harm requires better actions    eurocare.org

Why the public health community is disappointed with the European Parliament resolution on EU Alcohol Strategy[...]

Peroxyacetic acid: EFSA assesses safety and efficacy to reduce pathogens on poultry carcasses and meat    europa.eu

Published on: 26 March 2014 Using solutions containing peroxyacetic acid (PAA) to reduce contamination from pathogens on poultry carcasses and meat would not pose toxicity concerns, EFSA's experts sa[...]

EMA reorganisation: changes to handling of certain evaluation procedures to be introduced from 1 April 2014    europa.eu

The reorganisation of the European Medicines Agency (EMA) is now entering its next chapter.[...]

Scientific guideline: Concept paper on the revision of the guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins, draft: consultation open    europa.eu

The Guideline on Immunogenicity Assessment of Biotechnology-derived Therapeutic Proteins, CHMP/BMWP/42832/2005 laid down general recommendations for the performance of a systematic immunogenicity ass[...]

Scientific guideline: Draft concept paper for a guideline on user safety of topically administered products, draft: consultation open    europa.eu

This concept paper addresses the need for a specific user safety guideline for topically administered products. The CVMP adopted the revised general User Safety Guideline for pharmaceutical veterinar[...]

EDQM launches new database to assist authorities in the fight against counterfeit/falsified medical products    edqm.eu

24 March 2014 EDQM launches new database to assist authorities in the fight against counterfeit/falsified medical products As part of its anti-counterfeiting activities, the EDQM is pleased to announ[...]

Joint Statement: Tackling alcohol related harm requires better actions    eurocare.org

Why the public health community is disappointed with the European Parliament resolution on EU Alcohol Strategy[...]

[Joint Statement] Tackling alcohol related harm requires better actions    epha.org

Why the public health community is disappointed with the European Parliament resolution on EU Alcohol Strategy. On the 10th March Members of the Environment Public Health and Food Safety (ENVI) Commi[...]

European Parliament and Council back Commission's proposal for a Single Resolution Mechanism: a major step towards completing the banking union    europa.eu

Commission Statement Brussels, 20 March 2014 European President of the European Commission, José Manuel Barroso said: Today's political agreement on the single resolution mechanism completes our bank[...]

Pesticides and protected crops – EFSA presents environmental risk assessment guidance    europa.eu

Published on: 20 March 2014 New guidance from EFSA provides a framework for carrying out environmental risk assessment of pesticides emitted from protected crops - those grown in greenhouses and unde[...]

African swine fever: EFSA assesses control measures to prevent spread    europa.eu

Published on: 17 March 2014 Hunting is not a tool to drastically reduce the risk for introduction and spread of African swine fever virus in wild boar populations. Artificial feeding of wild boar mig[...]

Assessment of progress towards the Europe 2020 social inclusion objectives    europa.eu

With its objective of inclusive as well as smart and sustainable growth, and with its (first ever) EU poverty and social exclusion target, the Europe 2020 Strategy (potentially) increases the importa[...]

Call for scientific data for use in HMPC assessment work on Polygoni avicularis herba, draft: consultation open    europa.eu

Call for scientific data for use in HMPC assessment work on Polygoni avicularis herba Call for scientific data for use in HMPC assessment work on Polygoni avicularis herba hmpc.secretariat@ema.europ[...]

Call for scientific data for the systematic review of the monograph on Meliloti herba, draft: consultation open    europa.eu

Call for scientific data for the systematic review of the monograph on Meliloti herba Call for scientific data for the systematic review of the monograph on Meliloti herba hmpc.secretariat@ema.europ[...]

Development of a new Pan-Europea Paediatric formulary as a complementary contribution to other European activities for ensuring better medicines for children    edqm.eu

14 March 2014 Development of a new Pan-European paediatric formulary initiated as a complementary contribution to other European activities for ensuring better medicines for children The European Com[...]

Trends in Blood Transfusion in Europe: 2001-2008 Report now available    edqm.eu

12 March 2014 Trends in Blood Transfusion in Europe 2001-2008 Report now available This report is the second trend analysis report on the outcomes of the surveys requesting information on the collect[...]

Periodic Report Summary - TEAMSAFETY (The development project for an innovative 3D virtual team-training maritime safety simulation platform to meet the latest EU safety requirements ...)    europa.eumsw8

WORLD MARITIME UNIVERSITY Project context and objectives: TEAMSAFETY is a two-year project funded by the European Commission (EC)'s Seventh Framework Programme (FP7) within the 'Research for SMEs ass[...]

Report - Proposal for a Council Decision requiring Member States to ratify or to accede to the Hong Kong International Convention for the Safe and Environmentally Sound Recycling of Ships, 2009, in the interests of the EU - A7-0166/2014 - Committee on the Environment, Public Health and Food Safety    europa.eu

RECOMMENDATION on the draft Council decision concerning the ratification of, or the accession to, the Hong Kong International Convention for the Safe and Environmentally Sound Recycling of Ships, 200[...]

Commission welcomes adoption of Quality Framework to improve quality of traineeships    europa.eu

The European Commission welcomes today's adoption by the EU's Council of Minister of a Quality Framework on Traineeships to enable trainees to acquire high-quality work experience under safe and fair[...]

Youth employment: Commission welcomes adoption of guidelines to improve quality of traineeships    europa.eu

European Commission Press release Brussels, 10 March 2014 Quality Framework to improve quality of traineeships The European Commission welcomes today's adoption by the EU's Council of Minister of a Q[...]

Scientific guideline: Interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU, draft: consultation open    europa.eu

Interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU Interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU enhanced-surveil[...]

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 March 2014    europa.eu

The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) gave recommendations on three safety referrals at its March 2014 meeting.[...]

EMA and FDA extend pilot programme for parallel assessment of quality-by-design applications    europa.eu

As of 1 April 2014 the European Medicines Agency (EMA) and the United States Food and Drug Administration (US FDA) have agreed on a two-year extension of their joint pilot programme for the parallel [...]

WHO revising sugar guidelines    who.int

WHO is opening a public consultation on draft guidelines on sugar intake. They will provide countries with recommendations on limiting the consumption of sugars to reduce public health problems such [...]

Scientific guideline: Draft guideline on core SmPC for human fibrinogen products, draft: consultation open    europa.eu

This guideline describes the information to be included in the Summary of Product Characteristics (SmPC) for Human Fibrinogen, which is indicated for the treatment and prophylaxis of bleeding in pati[...]

African swine fever hits EU: EFSA assesses measures to prevent spread    europa.eu

Published on: 4 March 2014 At the end of January Poland and Lithuania reported cases of African swine fever in wild boars. This is the first time that this infectious disease has been reported in the[...]

Innovation performance: EU Member States, International Competitors and European Regions compared    europa.eu

European Commission MEMO Brussels, 4 March 2014 This Memo explains the objectives of the Innovation Union Scoreboard and provides an overview of the research and innovation performance of EU Member S[...]

50th Anniversary International conference: Register before 31 March to benefit from special Early Bird rates    edqm.eu

03 March 2014 50thAnniversary International conference: Register before 31 March to benefit from special Early Bird rates On 6-8 October 2014, the EDQM is organising a landmark international conferen[...]

Knowledge database: new version released    edqm.eu

03 March 2014 Knowledge database: new version released A new version of the Knowledge Database has been released: please read the instructions given under [...]

EDQM takes its first steps on social network Twitter    edqm.eu

03 March 2014 EDQM takes its first steps on social network Twitter The EDQM has recently created an account on the social network Twitter. Twitter is an online social networking and microblogging ser[...]

Scientific guideline: Draft reflection paper on the wording of indication for medicinal products for treatment of type 2 diabetes, draft: consultation open    europa.eu

Currently, the wording of the indication in section 4.1 of the SmPC (Summary of Product Characteristics) for recently approved centrally authorised medicinal products intended for the treatment of pa[...]

Scientific guideline: Draft guideline on the evaluation of the pharmacokinetics of medicinal products in patients with decreased renal function, draft: consultation open    europa.eu

Pharmacokinetic studies can be used to estimate drug exposure in subpopulations of patients with characteristics that might affect the pharmacokinetics of the drug, and alternative dosing regimens ma[...]

Scientific guideline: Draft concept paper on revision of the points to consider on pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products (CHMP/EWP/2655/99) and conversion to a CHMP guideline, draft: consultation open    europa.eu

This concept paper proposes a revision of the CHMP's points to consider on pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products (CPMP/EWP/2655/99) and its conv[...]

Scientific guideline: Draft guideline on the evaluation of medicinal products for the treatment of chronic constipation, draft: consultation open    europa.eu

This guideline intends to address the EU regulatory position in the main topics of clinical development of new medicinal products in the treatment of chronic constipation, opioid-induced constipation[...]

Alarming obesity rates in the WHO European Region require urgent action to protect children's health    epha.org

A recent WHO Europe Report, presenting an update on the marketing of foods high in fat, salt and sugar to children in the period 2012-2013, highlights increasing obesity rates in children. The overvi[...]

Guidelines on Diabetes: new resources available    escardio.org

In addition to the Full text of the ESC Clinical Practice Guidelines on Diabetes, Pre-Diabetes and Cardiovascular Diseases, developed with EASD, new related resources are now available. Discover the [...]

Scientific guideline: Questions and answers on Benzyl alcohol in the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’, draft: consultation open    europa.eu

The objective of this group is to update the labelling of selected excipients listed in the Annex of the above mentioned EC guideline, as well as to add new excipients to the list, based on a review [...]

Scientific guideline: Questions and answers on Benzoic acid and Benzoates in the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’, draft: consultation open    europa.eu

The objective of this group is to update the labelling of selected excipients listed in the Annex of the above mentioned EC guideline, as well as to add new excipients to the list, based on a review [...]

Scientific guideline: Questions and answers on Ethanol in the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’, draft: consultation open    europa.eu

The objective of this group is to update the labelling of selected excipients listed in the Annex of the above mentioned EC guideline, as well as to add new excipients to the list, based on a review [...]

NEOShield to assess Earth defence    europa.eu

The phenomenon of collisions in the history of our solar system is very fundamental, having played the major role in forming the planets we observe today. Asteroids and comets may have contributed to[...]

Regulatory and procedural guideline: VICH GL53 on Electronic exchange of documents: file format requirements, draft: consultation open    europa.eu

This guideline has been developed by the appropriate VICH Expert Working Group and is subject to consultation by the parties, in accordance with the VICH process. At step 7 of the process the final d[...]

Just published: Drug use in prison: assessment report    europa.eu

The report presents a review of tools for monitoring illicit drug use in prison population in Europe. The objective of the report is to describe the existing tools used at national level, to assess t[...]

GMP Non-Compliance : Information is now publicly available via the EudraGMDP data base    edqm.eu

21 February 2014 GMP Non-Compliance : Information is now publicly available via the EudraGMDP data base The European Medicines Agency (EMA) has launched a new version of the EudraGMDP database which [...]

New guidelines for Water Demand Management    europa.eu

The quality and the quantity of fresh water resources face increasing challenges in many parts of Europe. Climate change, rapid population growth and urbanistion, diminishing freshwater resources, an[...]

Scientific guideline: Lessons learned from the review of the labelling of centrally authorised pandemic vaccines, draft: consultation open    europa.eu

Lessons learned from the review of the labelling of centrally authorised pandemic vaccines Lessons learned from the review of the labelling of centrally authorised pandemic vaccines Email address fo[...]

Info Session on Applications - Pesticides – Technical meeting on Cumulative Risk Assessment    europa.eu

Published on: Stakeholders in the field of pesticides gathered in Parma, Italy to discuss EFSA's ongoing work to implement cumulative risk assessment (CRA) of pesticides in European Union legislation[...]

Lamivudine monograph (2217): Change of title to Lamivudine, anhydrous    edqm.eu

19 February 2014 Lamivudine monograph (2217): Change of title to Lamivudine, anhydrous During its 147th session, the Ph. Eur. Commission decided to indicate clearly that the published monograph for L[...]

Scientific guideline: Draft reflection paper on microbiological aspects of herbal medicinal products and traditional herbal medicinal products, draft: consultation open    europa.eu

Directive 2001/83/EC as amended and Directive 2001/82/EC as amended provide definitions for herbal substances, herbal preparations, and herbal medicinal products (HMPs). The basic legislation applies[...]

EFSA assesses safety of formaldehyde in feed    europa.eu

Published on: 18 February 2014 Formaldehyde is currently used as a feed additive and as a preservative for skimmed milk intended for pigs. In their risk assessment, EFSA's experts concluded that whil[...]

Third and Fourth Technical OMCL Counterfeit Training    edqm.eu

17 February 2014 Third and Fourth Technical OMCL Counterfeit Training 5-6 December 2013 and 30-31 January 2014, Vienna (Austria) Two new tailor-made hands-on training sessions for OMCLs on the testin[...]

Periodic Report Summary 3 - SPIDIA (Standardisation and improvement of generic pre-analytical tools and procedures for in vitro diagnostics)    europa.eumsw8

QIAGEN GMBH Project Context and Objectives: SPIDIA is a 4.5-years large-scale integrating project that works on the missing standardisation and improvement of pre-analytical procedures for in vitro d[...]

Periodic Report Summary 2 - TEMPOTEST-QC (An integrated toolkit for the clinical evaluation of microbial detection and antibiotic susceptibility point-of-care testing technologies)    europa.eumsw8

ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM Project context and objectives: In 2007, 2 European Union (EU) expert groups recommended that more emphasis be placed on research into tackling antimicr[...]

Periodic Report Summary 2 - PLANTLIBRA (Plant food supplements: levels of intake, benefit and risk assessment)    europa.eumsw8

UNIVERSITA DEGLI STUDI DI MILANO Project context and objectives: Botanicals have been used for centuries for their health-promoting effects. Across Europe, despite the current economic situation, pla[...]

Report - Monitoring, reporting and verification of carbon dioxide emissions from maritime transport and amendment of Regulation (EU) No 525/2013 - A7-0080/2014 - Committee on the Environment, Public Health and Food Safety    europa.eu

REPORT on the proposal for a regulation of the European Parliament and of the Council on the monitoring, reporting and verification of carbon dioxide emissions from maritime transport and amending Re[...]

Peer Review on ‘Emplois d’avenir’ – ‘Jobs for the future’ scheme    europa.eu

The Peer Review will focus on measures to improve the position of young people facing obstacles to access the labour market, a key objective of the European Employment Strategy as well as a top prior[...]

Peer Review: Minimum Wage    europa.eu

The Peer Review will focus on methods to determine and adapt national minimum wage levels while limiting negative impacts on employment or the economy.[...]

Scientific guideline: Concept paper on the need for a single note for guidance on the chemistry of active substances, draft: consultation open    europa.eu

Concept paper on the need for a single note for guidance on the chemistry of active substances Concept paper on the need for a single note for guidance on the chemistry of active substances Email ad[...]

Periodic Report Summary 2 - CAP2M-SCHED (Consolidation, industrial alignment and performance verification for movement to market of a scheduling solution featuring heuristics-enhanced simulation ...)    europa.eumsw8

PRINCEPS SARL Project context and objectives: The work carried out within CAP2M-SCHED was a direct consequence of the research and technological development (RTD) achievements of its precursor projec[...]

Scientific guideline: Concept paper on review and update of European Medicines Agency guidelines to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products, draft: consultation open    europa.eu

The Joint CHMP/CVMP ad-hoc expert group on the application of the 3Rs in the regulatory testing of medicinal products (JEG 3Rs), in coordination with relevant CHMP and CVMP working parties, has been [...]

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 February 2014    europa.eu

During its February meeting, the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) did not initiate or conclude a safety referral.[...]

Technical specifications for rail interoperability on accessibility for persons with reduced mobility: adopted!    euroblind.org

After almost three years of work, the Technical Specifications for rail Interoperability on accessibility for persons with reduced mobility (TSI-PRM) have been adopted by the Member States on 30 Janu[...]

JRC published a harmonisation framework for health-based evaluation of indoor emissions from construction products in the European Union    europa.eu

The harmonisation framework concerns the health based evaluation of chemical emissions from construction products based on the lowest concentration of interest (LCI) approach.[...]

Environmental risk assessment, new plant-breeding techniques: EFSA meets with NGOs    europa.eu

Published on: Environmental risk assessment and new plant-breeding techniques topped the agenda of a meeting in Brussels on 31 January between the European Food Safety Authority (EFSA) and non-govern[...]

EFSA welcomes stakeholder views on cumulative assessment group methodology    europa.eu

Published on: 5 February 2014 Stakeholders have delivered their feedback on EFSA's new approach for grouping pesticides that paves the way for implementing cumulative risk assessment of these substan[...]

The gold standard for cancer treatment    europa.eu

In the past, the best-known medical use of gold in the human body was probably limited to dental repairs, and even then considered by some to be a little ostentatious! But now, with the support of th[...]

Scientific guideline: Draft guideline on the investigation of subgroups in confirmatory clinical trials, draft: consultation open    europa.eu

Investigation into the effects of treatment in well-defined subsets of the trial population is an integral part of clinical trial planning, analysis and inference that follows the inspection of the p[...]

Regulatory information - EMA announces next steps for the maintenance of information on authorised medicines by marketing-authorisation holders    europa.eu

The European Medicines Agency (EMA) has released guidance today to support marketing-authorisation holders updating the information on authorised medicines that they have submitted to the Agency in a[...]

EFSA publishes 'stop-the-clock' timelines for regulated product applications    europa.eu

Published on: 31 January 2014 During the risk assessment of regulated products such as food contact materials, GMOs or feed additives EFSA may ask for additional information in order to complete its [...]

Counterfeit Medicines & Similar Crimes free publications    edqm.eu

29 January 2014 Counterfeit Medicines & Similar Crimes free publications The EDQM has just launched a new webpage dedicated to its publications in the field of counterfeit medicines and similar c[...]

Scientific guideline: Draft guideline on key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products, draft: consultation open    europa.eu

This guideline addresses the influence of pharmacogenomics on pharmacovigilance activities, including considerations on how to evaluate the pharmacovigilance related issues for medicinal products wit[...]

EMA releases guidance on the use of pharmacogenomics to improve safety monitoring of medicines    europa.eu

The European Medicines Agency has released a draft guideline for public consultation which addresses how pharmacogenomics can support pharmacovigilance activities and in particular how the results of[...]

Just published: Risk assessment of 4-MA    europa.eu

This report presents the data and findings of the risk assessment on the new psychoactive substance, 4-methylamphetamine, that was conducted by the Scientific Committee of the EMCDDA. Concerns over t[...]

Just published: 5-IT risk assessment    europa.eu

This report presents the data and findings of the risk assessment on the new psychoactive substance, 5-(2-aminopropyl)indole, that was conducted by the Scientific Committee of the EMCDDA. Concerns ov[...]

Just published: Risk assessment of 4-MA    europa.eu

This report presents the data and findings of the risk assessment on the new psychoactive substance, 4-methylamphetamine, that was conducted by the Scientific Committee of the EMCDDA. Concerns over t[...]

Scientific guideline: Draft guideline on core SmPC and package leaflet for (99Mo/99mTc) generator, draft: consultation open    europa.eu

This guideline describes the information to be included in the Summary of Products Characteristics (SmPC) and Package Leaflet for (99Mo/99mTc) generator.[...]

Counterfeit Medicines & Similar Crimes free publications    edqm.eu

29 January 2014 Counterfeit Medicines & Similar Crimes free publications The EDQM has just launched a new webpage dedicated to its publications in the field of counterfeit medicines and similar c[...]

Outcome of the joint EDQM/EMA workshop on characterisation of new clotting factor concentrates    edqm.eu

28 January 2014 Outcome of the workshop - Joint EMA / EDQM workshop on characterisation of new clotting factor concentrates (factor VIII and factor IX) with respect to potency assays used for labelli[...]

Super wind turbines represent a major technological breakthrough    europa.eu

Harnessing the wind's energy is the objective of a new project, which aims to provide an important breakthrough in offshore wind industrial solutions. The EU-funded project, called SUPRAPOWER, is wor[...]

EDQM announces the extension of its ISO 9001:2008 Certification to the conduct of laboratory studies    edqm.eu

08 January 2014 EDQM announces the extension of its ISO 9001:2008 Certification to the conduct of laboratory studies The EDQM is now certified for several more activities. The updated certificate was[...]

Periodic Report Summary - EUIMA (Take-up activities by universities of specific guidelines and recommendations to implement their modernisation agenda)    europa.eumsw8

ASSOCIATION EUROPEENNE DE L'UNIVERSITE Project context and objectives: The 'European universities implementing their modernisation agenda' (EUIMA) project addresses two major elements of the modernis[...]

Assessing the long term impact of HPV screening on cervical cancer detection    europa.eu

Cervical cancer screening has helped to dramatically reduce the number of cases of - and mortality from - this disease. Now a study from the Karolinska Institutet suggests that testing for the human [...]

New Resolution on live kidney donation programmes adopted by the Committee of Ministers    edqm.eu

22 January 2014 Resolution CM/Res(2013)56 on the development and optimisation of live kidney donation programmes Even though many countries with established transplant programmes have improved their [...]

EDQM announces the extension of its ISO 9001:2008 Certification to the conduct of laboratory studies    edqm.eu

08 January 2014 EDQM announces the extension of its ISO 9001:2008 Certification to the conduct of laboratory studies The EDQM is now certified for several more activities. The updated certificate was[...]

The EDQM adds NMR to its analytical competencies    edqm.eu

07 January 2014 The EDQM adds Nuclear magnetic resonance (NMR) to its analytical competencies As a result of a project launched in 2011, and completed in December 2013, the European Directorate for t[...]

Certification – Submission of information through the centralised European submission platform “CESP”    edqm.eu

20 December 2013 Certification - Submission of information through the centralised European submission platform [...]

Periodic Report Summary 1 - NTM-IMPACT (Assessment of the impacts of non-tariff measures - NTM on the competitiveness of the EU and selected trade partners)    europa.eumsw8

CENTRE DE COOPERATION INTERNATIONAL EN RECHERCHE AGRONOMIQUE POUR LE DEVELOPPEMENT Objectives and organisation The overall objective of the project is to collect and analyse new data on non-tariff me[...]

Periodic Report Summary - MANUCLOUD (Distributed Cloud product specification and supply chain manufacturing execution infrastructure)    europa.eumsw8

FRAUNHOFER-GESELLSCHAFT ZUR FOERDERUNG DER ANGEWANDTEN FORSCHUNG E.V Project context and objectives: The transition from mass production to personalised, customer-oriented and eco-efficient manufactu[...]

Periodic Report Summary - MAARBLE (Monitoring, Analyzing and Assessing Radiation Belt Loss and Energization)    europa.eumsw8

NATIONAL OBSERVATORY OF ATHENS Project context and objectives: The MAARBLE project has two focused and synergistic aims: - to advance scientific research on radiation belt dynamics, and - to enhance [...]

New Resolution on live kidney donation programmes adopted by the Committee of Ministers    edqm.eu

22 January 2014 Resolution CM/Res(2013)56 on the development and optimisation of live kidney donation programmes Even though many countries with established transplant programmes have improved their [...]

Report on Progress under the Co-operation and Verification Mechanism in Bulgaria    europa.eu

European Commission MEMO Brussels, 22 January 2014 Why does the Commission report on progress in judicial reform, the fight against corruption and the fight against organised crime in Bulgaria? Upon [...]

Report on Progress under the Co-operation and Verification Mechanism in Romania    europa.eu

European Commission MEMO Brussels, 22 January 2014 Why does the Commission report on progress in judicial reform and the fight against corruption in Romania? Upon accession of Romania on 1 January 20[...]

Commission issues report on progress in Romania under the Co-operation and Verification Mechanism    europa.eu

European Press release Brussels, 22 January 2014 Commission The report presents the Commission's analysis on the steps Romania has taken in the past twelve months and shows where further steps are ne[...]

Commission issues report on progress in Bulgaria under the Co-operation and Verification Mechanism    europa.eu

European Press release Brussels, 22 January 2014 Commission The report presents the Commission's analysis on the steps Bulgaria has taken in the past eighteen months and shows where further steps are[...]

New Resolution on organ transplantation adopted by the Committee of Ministers    edqm.eu

22 January 2014 Resolution CM/Res(2013)55 on establishing procedures for the collection and dissemination of data on transplantation activities outside a domestic transplantation system Trafficking i[...]

Periodic Report Summary - CASSANDRA (Common assessment and analysis of risk in global supply chains)    europa.eumsw8

NEDERLANDSE ORGANISATIE VOOR TOEGEPAST NATUURWETENSCHAPPELIJK ONDERZOEK (TNO) Project context and objectives: The main objective of the project CASSANDRA is to enable and facilitate the combination o[...]

Training activities – Register Now: EU SHIPSAN ACT Joint Action 2012 2013    europa.eu

The Consumers, Health and Food Executive Agency implements the EU Health Programme, the Consumer Programme and the Better Training for Safer Food initiative[...]

Trends in initial evaluation of veterinary medicines by EMA in 2013    europa.eu

In 2013, the European Medicines Agency's (EMA) Committee for Medicinal Products for Veterinary Use started the evaluation of a record number of 23 marketing-authorisation applications for new veterin[...]

Bisphenol A: EFSA consults on assessment of risks to human health    europa.eu

EFSA is the EU risk assessment body for food and feed safety. It provides independent scientific advice to risk managers.[...]

Bisphenol A: EFSA consults on assessment of risks to human health    europa.eu

Published on: 17 January 2014 EFSA is launching a public consultation on its draft assessment of the human health risks posed by exposure to bisphenol A (BPA). The Authority has undertaken a comprehe[...]

List of publications updated    europa.eu

European Commission - 0[...]

EDQM Store closed for maintenance    edqm.eu

14 January 2013 EDQM Store Closed for Maintenance We wish to inform you that the EDQM Store will be closed and inaccessible due to maintenance on 14th (from 12.00 pm), 15th and 16th January. Sorry fo[...]

ICT industry requires more skills to take off    europa.eu

The launch of Horizon 2020 and the EUR 15 million it brings to the ICT research table are definitely a breath of fresh air for the sector. However, one question remains: do EU workers have the skills[...]

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 January 2014    europa.eu

Following an in-depth review of the medicine, the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that Protelos/Osseor should no longer be used to treat[...]

Final Report Summary - THICK VALUE CONCEPTS (Thick evaluative concepts: value, reasons, and the natural world)    europa.eumsw8

UNIVERSITY OF LEEDS The THICK VALUE CONCEPTS project concerns an area of moral philosophy known as meta-ethics. One central topic of meta-ethics is the meaning and function of evaluative language and[...]

Periodic Report Summary 2 - THICK VALUE CONCEPTS (Thick evaluative concepts: value, reasons, and the natural world)    europa.eumsw8

UNIVERSITY OF LEEDS The THICK VALUE CONCEPTS project concerns an area of moral philosophy known as meta-ethics. One central topic of meta-ethics is the meaning and function of evaluative language and[...]

EDQM announces the extension of its ISO 9001:2008 Certification to the conduct of laboratory studies    edqm.eu

08 January 2014 EDQM announces the extension of its ISO 9001:2008 Certification to the conduct of laboratory studies The EDQM is now certified for several more activities. The updated certificate was[...]

Final Report Summary - HIGHRESDESI (Desorption electrospray ionisation (DESI) coupled to a high resolution mass spectrometer: fundamental studies and improvements of analytical performance)    europa.eumsw8

MIKROBIOLOGICKY USTAV AKADEMIE VED CESKE REPUBLIKY VVI Introduction The objective of this project was to improve analytical performance of Desorption electrospray ionisation (DESI) coupled to a high [...]

The EDQM adds NMR to its analytical competencies    edqm.eu

07 January 2014 The EDQM adds Nuclear magnetic resonance (NMR) to its analytical competencies As a result of a project launched in 2011, and completed in December 2013, the European Directorate for t[...]

Committee presents candidates for Secretary General Elect and Chair of the Guidelines Office    uroweb.org

Following an open application process in the summer of 2013, the EAU Search and Nomination Committee has put forth two candidates for approval at the next EAU General Assembly. Prof. Christopher Chap[...]

Scientific guideline: Draft guideline on core summary of product characteristics for plasma-derived fibrin sealant / haemostatic products, draft: consultation open    europa.eu

This guideline describes the information to be included in the Summary of Product Characteristics (SmPC) for plasma-derived fibrin sealant / haemostatic products.[...]

Certification – Submission of information through the centralised European submission platform “CESP”    edqm.eu

20 December 2013 Certification - Submission of information through the centralised European submission platform [...]

Assessing the full potential of global stem cell research    europa.eu

The stem cell research sector is growing more than twice as fast (7%) as the global research average (2. 9%), according to a new report. The study, which examined the growth and development of the st[...]

Counterfeit medicines & similar crimes: New publications available on the EDQM Store    edqm.eu

18 December 2013 Counterfeit medicines & similar crimes: New publications available on the EDQM Store The EDQM has published a number of publications on counterfeit medicines. These publications [...]

Office closure    edqm.eu

18 December 2013 Holiday Closure Dates The EDQM office will be closed from Monday afternoon, 23 December 2013 until Thursday, 2 January 2014.[...]

EDQM website: interruption of service on 27 December    edqm.eu

18 December 2013 EDQM website: interruption of service on 27 December The EDQM would like to inform you of the possible interruption of service on the EDQM website on Friday 27 December from 10:00 to[...]

European Medicines Agency and FDA announce launch of generic medicines application inspections initiative    europa.eu

The European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) today announced the launch of a joint initiative to share information on inspections of bioequivalence stu[...]

EFSA evaluates molecular typing methods for food-borne pathogens    europa.eu

Published on: 18 December 2013 Molecular typing methods are laboratory techniques, such as whole genome sequencing, that enable the classification and comparison of strains of disease-causing bacteri[...]

Good practice guidelines for blood establishments    edqm.eu

13 December 2013 Good Practice Guidelines for Blood Establishments and Hospital Blood Banks Required to Comply with EU Directive 2005/62/EC The document has been elaborated as a co-operation between [...]

EFSA assesses potential link between two neonicotinoids and developmental neurotoxicity    europa.eu

EFSA is the EU risk assessment body for food and feed safety. It provides independent scientific advice to risk managers.[...]

EFSA assesses potential link between two neonicotinoids and developmental neurotoxicity    europa.eu

Published on: 17 December 2013 Two neonicotinoid insecticides - acetamiprid and imidacloprid - may affect the developing human nervous system, said the European Food Safety Authority (EFSA). Experts [...]

Scientific guideline: Draft VICH GL52 on Bioequivalence: blood level bioequivalence study, draft: consultation open    europa.eu

This guideline is intended to harmonize the data requirements associated with in vivo blood level bioequivalence (BE) for veterinary pharmaceutical products.[...]

Regulatory and procedural guideline: Draft recommendation on pharmacovigilance surveillance and signal detection of veterinary medicinal products, draft: consultation open    europa.eu

Veterinary medicinal products (VMPs) are granted a marketing authorisation in the European Union (EU) based on demonstration of quality, safety and efficacy through experimental data involving the ta[...]

Good practice guidelines for blood establishments    edqm.eu

13 December 2013 Good Practice Guidelines for Blood Establishments and Hospital Blood Banks Required to Comply with EU Directive 2005/62/EC The document has been elaborated as a co-operation between [...]

Doing the twist: taking assessment of LV function beyond ejection fraction    escardio.org

Echocardiography methods for assessing Left Ventricular (LV) function that go beyond ejection fraction (EF) need to be introduced routinely into clinical practice, says Otto Smiseth. The widespread i[...]

Season's greetings    europa.eu

Season's greetings from EEA[...]

NEW: Safe Cosmetics for Young Children available in Spanish version    edqm.eu

04 December 2013 NEW: Safe Cosmetics for Young Children available in Spanish Safe Cosmetics for Young Children, A Guide for Manufacturers and Safety Assessors (1st Edition 2012) is now available onli[...]

Periodic Report Summary - NANOANTENNA (Development of a high sensitive and specific nanobiosensor (...) dedicated to the in vitro proteins detection and disease diagnosis)    europa.eumsw8

CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE Project Context and Objectives: Despite some recent advances, the detection of traces of biological species in medical diagnosis remains a challenge at th[...]

Black carbon: Better monitoring needed to assess health and climate change impacts    europa.eu

Black carbon is an air pollutant which harms human health and can contribute to climate change - so cutting emissions may have many benefits. The European Environment Agency (EEA) has published a rep[...]

Systemic seismic vulnerability assessment software user’s manual - Just Published - EU Bookshop    europa.eu

Systemic seismic vulnerability assessment software user’s manual[...]

Assessment of benefits from the RFCS research programme - Just Published - EU Bookshop    europa.eu

Assessment of benefits from the RFCS research programme[...]

EFSA completes full risk assessment on aspartame and concludes it is safe at current levels of exposure    europa.eu

EFSA is the EU risk assessment body for food and feed safety. It provides independent scientific advice to risk managers.[...]

EFSA completes full risk assessment on aspartame and concludes it is safe at current levels of exposure    europa.eu

Published on: 10 December 2013 Aspartame and its breakdown products are safe for human consumption at current levels of exposure, EFSA concludes in its first full risk assessment of this sweetener. T[...]

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 December 2013    europa.eu

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has started a further in-depth review of the benefits and risks of the leukaemia medicine Iclusig, particularly the [...]

Press Release: EFA’s new book on Minimum Standards of COPD care    efanet.org

Standards of Care for COPD patients are not equal in Europe EFA reveals the state of play and releases Minimum Standards of Care to enable active patients participating in society COPD is a serious l[...]

[Child Safety Product Guide] Products Specifically designed for children are causing injuries that could be avoided    epha.org

Vilnius, Thursday, 5 December, 2013 - Each day children are injured when interacting with products in their everyday environment; even with products made especially for children. Estimates from the E[...]

Research shades light on how to improve alcohol consumption estimates    eurocare.org

University of Glasgow Institute of Health and Wellbeing project explores and addresses non-response bias in health surveys with a focus on alcohol consumption.[...]

Scientific guideline: Draft sunitinib product-specific bioequivalence guidance , draft: consultation open    europa.eu

Draft sunitinib product-specific bioequivalence guidance Draft sunitinib product-specific bioequivalence guidance Email address for submissions pkwpsecretariat@ema.europa.eu [...]

Youth employment: Commission proposes standards to improve quality of traineeships    europa.eu

Guidelines to enable trainees to acquire high-quality work experience under safe and fair conditions, and to increase their chances of finding a good quality job, have been proposed today by the Euro[...]

Youth employment: Commission proposes standards to improve quality of traineeships    europa.eu

European Commission Press release Brussels, 4 December 2013 Guidelines to enable trainees to acquire high-quality work experience under safe and fair conditions, and to increase their chances of find[...]

Assessment of the risk to humans posed by exposure to low levels of chemicals    eufic.org

The Threshold for Toxicological Concern (TTC) is an approach used to assess the risk (if any) posed by chemicals to which humans are exposed at very low levels but when no toxicity data are available[...]

EFSA expands body of work on cumulative risk assessment    europa.eu

Published on: 3 December 2013 EFSA presents its conclusions on the relevance of dissimilar mode of action as part of its ongoing work in the field of cumulative risk assessment (CRA) of pesticide res[...]

Scientific guideline: Concept paper on the second revision of the guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products, draft: consultation open    europa.eu

This concept paper is concerned with the revision of the clinical and non-clinical sections of the guideline on the use of the Common Technical Document (CTD) format in the preparation of a registrat[...]

Front-running cities changing transport, improving quality of life    europa.eu

Many cities in Europe are changing, according to a new report which points to rapid transformations in urban transport in some areas. While cycling and efficient public transport are becoming the nor[...]

EFSA Scientific Colloquium XIX: Biodiversity as protection goal in environmental risk assessment for EU agro-ecosystems    europa.eu

Published on: Programme and presentationsNearly 100 people from a wide range of scientific backgrounds, including many risk assessors and risk managers, gathered in Parma, Italy, to discuss how to es[...]

Standards for COPD Care Now    efanet.org

EFA Releases its Book on COPD in Europe Seeking Minimum Standards of Care At the EFA-ECC World Chronic Obstructive Pulmonary Disease (COPD) Day Event in Brussels on November 28th, the EFA Book on Min[...]

Christmas closure for dispatch of publications and reference standards    edqm.eu

5 November 2013 Christmas closure for dispatch of publications and reference standards The EDQM will be closed from Monday afternoon, 23 December 2013 and reopens Thursday 02 January 2014. Deadlines [...]

European Pharmacopoeia and Traditional Chinese Medicines    edqm.eu

29 November 2013 European Pharmacopoeia and Traditional Chinese Medicines The EDQM, Council of Europe and the State Administration of Traditional Chinese Medicine of the People's Republic of China (S[...]

147th Session of the European Pharmacopoeia Commission    edqm.eu

02 December 2013 147th Session of the European Pharmacopoeia Commission At its 147th session, the European Pharmacopoeia Commission approved the priorities for the three coming years, which are aimed[...]

Minimum Standards of Care for COPD Patients in Europe    efanet.org

EFA is excited to release its second book concerning COPD in Europe, the EFA Book on Minimum Standards of Care for COPD patients in Europe, which was produced as a result of the EFA COPD Project. The[...]

European Pharmacopoeia and Traditional Chinese Medicines    edqm.eu

29 November 2013 European Pharmacopoeia and Traditional Chinese Medicines The EDQM, Council of Europe and the State Administration of Traditional Chinese Medicine of the People's Republic of China (S[...]

Early dialogue between regulators and health technology assessment bodies key to medicines development    europa.eu

Early dialogue between regulators and health technology assessment bodies key to medicines development Early dialogue between regulators and health technology assessment bodies key to medicines deve[...]

Benchmarks for the assessment of wage developments - Just Published - EU Bookshop    europa.eu

Benchmarks for the assessment of wage developments[...]

Scientific guideline: Draft guideline on the adventitious agent safety of urine-derived medicinal products, draft: consultation open    europa.eu

Human urine is used to prepare several products indicated in the field of endocrinology, such as human chorionic gonadotropin (hCG), human menopausal gonadotropin or menotropin (HMG) and follicle-sti[...]

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