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Uutisia (Lääkkeet ja hoito)
Terveys-EU-sivuston uutis- ja tapahtumasyötteet tuotetaan automaattisesti Euroopan komission määrittelemien kriteerien mukaisesti. Luokitteluvirheet ovat mahdollisia.
Public consultation on advanced therapy medicinal products» europa.eu
European Commission - A summary of the responses is here. Academic GMP Research Consortium[...]European Medicines Agency issues six key recommendations to tackle the issue of medication errors» europa.eu
The European Medicines Agency (EMA) has issued six key recommendations to tackle the issue of medication errors causing harm in the European Union (EU).[...]European Medicines Agency reiterates PRAC recommendation for Diane 35 and generics» europa.eu
Following the conclusion of the Pharmacovigilance Risk Assessment Committee (PRAC) that the benefits of Diane 35 and its generics outweigh the risks in a specific patient group, the French National A[...]International Clinical Trials Day: 20 May 2013» europa.eu
The European Medicines Agency supports International Clinical Trials Day, which is took place on Monday 20 May 2013.[...]European Medicines Agency recommends first vaccine for foot-and-mouth disease for authorisation at EU level» europa.eu
The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) has recommended the marketing authorisation for Aftovaxpur DOE for use in response to outbreaks of foot-and-[...]Benefits of Diane 35 and generics outweigh risks in specific patient group » europa.eu
The European Medicines Agency?s Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that the benefits of Diane 35 (cyproterone acetate 2 mg, ethinylestradiol 35 micrograms) and its gener[...]European Patients' Rights Day: 10 benefits the EU brings to patients» europa.eu
Commission MEMO Brussels, 15 May 2013 European A high level of health protection; the right to benefit from medical treatment; access to healthcare - preventive, diagnostic and curative treatment reg[...][EPHA Briefing] Access to Medicines in Europe in Times of Austerity» epha.org
When discussing the topic of access to medicines in the context of the economic crisis we have to consider three determinants: affordability and availability, in terms of access to medicines, and inn[...]Hospital visits take on new meaning with therapeutic robots» europa.eu
Having hospital visits from a robot may sound like a strange form of therapy, but according to robotics experts, they can be extremely helpful therapeutic devices. The idea comes from the MOnarCH pro[...]Commission awards prizes to best eHealth SMEs»
The winners of the 2nd EU SME eHealth Competition came up with innovations in areas such as improving cognitive behavioural therapy for mental care, improving physiological monitoring, and people facing emergencies.
New recommendations on the use of phthalates and parabens as excipients in human medicines released for public consultation» europa.eu
The European Medicines Agency has published today a draft guideline on the use of phthalates and a reflection paper on the use of parabens as excipients in human medicines, which include precautionar[...]Launch of World MS Day 2013: Raising awareness of the challenges facing young people with MS»
The campaign this year centres on asking ‘What’s your Motto?’. We all have mottos and inspirational words that get us through the tough times in life. The 2013 campaign will share the mottos of six inspiring young people for identity, relationships and the future, as well as inviting the public and people with MS to share their own mottos on the website.
European gene therapy research may restore essential human senses» europa.eu
A world without hearing, sight or smell; without music, the light of the day or the scent of a delicious meal. This is the reality for those who suffer from congenital cilia diseases, a condition ste[...]European Medicines Agency reorganisation» europa.eu
The first details of the planned reorganisation of the European Medicines Agency (EMA) have been announced.[...]Research Headlines - Sweetening the bitter pill of cancer treatment» europa.eu
Despite a massive research effort, cancer is still a major killer in Europe. European researchers are working on a sugar-based drug-delivery system which they believe will boost the potency of anti-c[...]European Medicines agency publishes final advice from clinical trial advisory groups» europa.eu
The European Medicines Agency (EMA) has published the final advice from the advisory groups that have been set up to inform the EMA in drafting its policy on proactive access to clinical-trial data.[...]RareConnect announces 40th online community»
RareConnect.org, the platform created, monitored and run by patient organisations EURORDIS and NORD, continues its mission of bringing rare disease patients together, across borders and beyond language barriers
Recommendation to suspend tetrazepam-containing medicines endorsed by CMDh » europa.eu
Following the recent recommendation by the Pharmacovigilance Risk Assessment Committee (PRAC), the Co-ordination Group for Mutual Recognition and Decentralised Procedures ? Human (CMDh) has endorsed [...]European Medicines Agency recommends approval of first treatment for pseudobulbar affect (europa.eu, ) »
The European Medicines Agency?s Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of a marketing authorisation for Nuedexta, a medicine for the treatment of pseudobul[...]European Medicines Agency recommends approval of combined advanced-therapy product (europa.eu, ) »
The European Medicines Agency?s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for MACI (matrix-induced autologous chondrocyte implantation), an advance[...]Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2013 (europa.eu, ) »
This page provides an overview of the opinions adopted at the April 2013 meeting of the CHMP and other important outcomes.[...]
Periodic Report Summary - CANCERALIA (Development of novel diagnostic and therapeutic approaches to improve patient outcome in lung and pancreatic tumours)»
europa.eu
FUNDACION CENTRO NACIONAL DE INVESTIGACIONES ONCOLOGICAS CARLOS III Project context and objectives: Lung and pancreatic cancer represent major public health challenges in Europe and the western world[...]The European Medicines Agency (EMA) publishes list of drugs under additional monitoring» epha.org
As part of the deliverables of the pharmacovigilance legislation that came into effect in July 2012, the European Medicines Agency (EMA) released an initial list of drugs subject to additional monito[...]European Medicines Agency publishes initial list of medicines under additional monitoring» europa.eu
The European Medicines Agency has published today the initial list of medicines that are subject to additional monitoring.[...]New treatment may lead the way to fighting obesity and diabetes» europa.eu
Two professors believe they may have a promising lead from which to develop a new treatment for obesity and diabetes. The project titled i2MOVE ('Intelligent implantable modulator of vagus nerve func[...]Stem cell therapy treatments» europa.eu
Concerns have been raised in the media about certain stem cell therapy treatments.[...]World Immunisation week (20-27 April) – New vaccine scheduler»
A new interactive platform of vaccination schedules for individual European countries and for specific age groups has been developed by the European Centre for Disease Prevention and Control (ECDC), with the Groupe d’Etudes en Preventologie.
Global Forum unites international organisations to tackle how to best prevent CVD» escardio.org
International initiatives and national strategies outlining important steps to prevent the ongoing spread of CVD will be presented Friday afternoon at the Global Forum for CVD Prevention in Clinical [...]Key deliverable of Falsified Medicines Directive achieved » europa.eu
The European Medicines Agency has upgraded its EudraGMP database so that it now contains information on good distribution practice (GDP) in addition to good manufacturing practice (GMP).[...]EP resolution underlines the need for action on medicines access problem» epha.org
On 18 April, the European Parliament (EP) voted on a Resolution on the impact of the financial and economic crisis on human rights. The resolution highlighted some of the global impacts of the crisis[...]European Medicines Agency publishes 2012 annual report» europa.eu
The European Medicines Agency has published today its 2012 annual report. The report highlights the main trends recently observed in the Agency?s activities.[...]Use of antibiotics in animals - EMA to give advice to European Commission on public and animal health impact» europa.eu
The European Medicines Agency (EMA) will provide advice on the impact on public health and animal health of the use of antibiotics in animals. The request was made by the European Commission as part [...]
Final Report Summary - EUSANH-ISA (Improving science advice for health in Europe, EUSANH)»
europa.eu
HEALTH COUNCIL OF THE NETHERLANDS Executive summary: The European science advisory network for health (EUSANH) is a collaborative network of science advisory bodies (SABs) within the European Union ([...]Guideline on good pharmacovigilance practices: Product-or population-specific considerations I: Vaccines for prophylaxis against infectious diseases: consultation open» europa.eu
The objective of this module is to strengthen the conduct of pharmacovigilance for vaccines. It should be noted that the overall objectives and processes of pharmacovigilance are no different for vac[...]Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 April 2013» europa.eu
The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restrictions in the use of Protelos/Osseor (strontium ranelate) based on the outcome of a routine be[...]EU agencies consider phenylbutazone detected in horsemeat of low concern for consumers; recommend improved horse traceability and monitoring of veterinary medicinal residues» europa.eu
A joint assessment from the European Food Safety Authority (EFSA) and the European Medicines Agency (EMA) concludes that the illegal presence of residues of phenylbutazone in horsemeat is of low conc[...]New therapy for fragile X chromosome syndrome discovered» europa.eu
Researchers at the University of the Basque Country (UPV/EHU) and the Achucarro neurosciences centre have discovered a new therapy for the fragile X chromosome syndrome, the most widespread cause of [...]Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 9-11 April 2013» europa.eu
The Committee adopted by consensus a positive opinion for an initial marketing authorisation application for Equilis West Nile from Intervet International B.V. a vaccine for the active immunisation o[...]Guideline on good pharmacovigilance practices: P I - Vaccines for prophylaxis against infectious diseases – Definitions for inclusion in GVP annex I: consultation open» europa.eu
Guideline on good pharmacovigilance practices (GVP): P I - Vaccines for prophylaxis against infectious diseases – Definitions for inclusion in GVP annex I Guideline on good pharmacovigilance practice[...]Exploiting a new genetic model in the study of Parkinson's disease» europa.eu
Parkinson's disease is the second most widespread neurodegenerative disease in the world, with an estimated 1.2 million sufferers in Europe alone. One Marie Curie Fellow is carrying out innovative ge[...]EPHA briefing on cyber security and health technologies» epha.org
Below is an updated version of the EPHA briefing on cyber security and health technologies, first published in September 2012, taking account of developments and further EPHA work since then. As note[...]European Medicines Agency publishes report on patient recruitment and geographical location of clinical trials» europa.eu
Almost 62% of the patients in pivotal trials submitted in marketing-authorisation applications (MAAs) to the European Medicines Agency between January 2005 and December 2011 were recruited outside of[...]Reducing the costs and trauma of inner ear implant surgery» europa.eu
People who are hard of hearing not only face the risk of slipping into social isolation due to their condition but, more seriously, they can also be at risk during simple, everyday activities: such a[...]Targeted cancer treatment shows real promise» europa.eu
An EU-funded research project is working to overcome current chemotherapy-related challenges, developing a new method which directs drug delivery exclusively to tumours, increasing effectiveness whil[...]World Health Day 2013 - Control your blood pressure» escardio.org
The WHO and partners focus on the global problem of high blood pressure (BP). Many people do not know they have high BP. As a result, it leads to more than nine million deaths every year, including a[...]World Health Day on 7 April 2013: focus on high blood pressure» europa.eu
The European Medicines Agency supports World Health Day, taking place on Sunday 7 April 2013.[...]Concept paper on the need for a reflection paper on quality aspects of medicines for older people: consultation open» europa.eu
Unlike the paediatric case (regulation (EC) No 1901/2006), there is no specific legal requirement for the development of medicines for geriatric use. Nevertheless, there is a need to ensure that medi[...]Using bioglass to mend bones» europa.eu
Bones have an amazing ability to regenerate after suffering slight damage. Past a certain point however, this natural healing process is really put to the test. When breaks are too big, bones need a [...]Integrating cardiovascular imaging modalities revolutionises care offered to patients » escardio.org
How the different advanced cardio vascular imaging technologies fit together in managing cardiac patients, will be one of the main themes explored at the International Conference on Nuclear Cardiolog[...]Concept paper on the development of medicinal products for the treatment of autism spectrum disorder: consultation open» europa.eu
Autism spectrum disorders (ASDs) are a group of neurodevelopmental disabilities with symptoms typically presenting before the age of 3 years and persisting into adulthood. They are described as[...]Future treatment of gonorrhoea at risk: new ECDC report» europa.eu
Effective control of gonorrhoea, the second most commonly reported sexually transmitted infection in Europe, relies on successful antimicrobial treatment. As data from the ECDC report Gonococcal anti[...]European Medicines Agency Workshop on Medication Errors» epha.org
The European Medicines Agency (EMA) organised a workshop on Medication Errors on 28 February - 1 March, a timely event given that such incidents are much more frequent across Europe than is commonly [...]European Medicines Agency to begin PSUR assessment based on active substances in both centrally and nationally authorised medicines» europa.eu
On 1 April 2013, the European Medicines Agency will start carrying out single assessments of the periodic safety update reports (PSURs) of active substances contained in both centrally and nationally[...]European Medicines Agency investigates findings on pancreatic risks with GLP-1-based therapies for type 2 diabetes» europa.eu
The European Medicines Agency is investigating findings by a group of independent academic researchers that suggest an increased risk of pancreatitis (inflammation of the pancreas) and pre-cancerous [...]HIV/AIDS: Treatment as prevention - Evidence from Europe and beyond» aidsactioneurope.org
As part of its European HIV prevention work, NAM is collaborating with AVAC to provide a series of webinars (conference calls with accompanying slides) to train and inform prevention advocates and an[...]European Medicines Agency issues recommendations for 2013/2014 seasonal flu vaccine composition» europa.eu
The European Medicines Agency has issued the European Union (EU) recommendations for the influenza virus strains that should be included in vaccines for the prevention of seasonal influenza next wint[...]European Medicines Agency updates procedural guidance in line with new pharmacovigilance legislation» europa.eu
The European Medicines Agency has revised its procedural guidance for pharmaceutical companies to include the latest information related to the new pharmacovigilance legislation.[...]European Medicines Agency’s Management Board welcomes new civil-society members» europa.eu
The European Medicines Agency's Management Board held its first meeting in 2013 on 20-21 March 2013. The Board welcomed four new civil-society representatives as full members.[...]EDCTP-funded projects for tuberculosis vaccines» edctp.org
Every year 9 million people are newly diagnosed with tuberculosis (TB). The disease kills approximately 1.4 million people per year including infants and adolescents. TB/HIV co-infection and MDR/XDR-[...]Draft guideline on the declaration of the quantitative composition / labelling of biological medicinal products that contain modified proteins as active substance: consultation open» europa.eu
Draft guideline on the declaration of the quantitative composition / labelling of biological medicinal products that contain modified proteins as active substance Draft guideline on the declaration o[...]Call for experts: EDCTP Strategic Advisory Committee and EDCTP Interim Strategic Advisory Committee» edctp.org
EDCTP is calling on high level experts from across multiple fields and sectors to apply for membership of the Interim Strategic Advisory Committee (Interim SAC) and the Strategic Advisory Committee ([...]Using simpler synthesis and greener chemistry to improve medicines» europa.eu
An estimated 170 million people worldwide are infected with hepatitis C, which kills more than 350,000 every year from related illnesses like liver cancer. There is no vaccine for it, and treatments [...]Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 March 2013» europa.eu
This page provides an overview of the opinions adopted at the March 2013 meeting of the CHMP and other important outcomes.[...]European Medicines Agency recommends restricting use of cilostazol-containing medicines» europa.eu
The European Medicines Agency's Committee on Medicinal Products for Human Use (CHMP) has recommended that the use of cilostazol-containing medicines in the treatment of intermittent claudication - a [...]Informing relatives of heart or lung transplantation patients» escardio.org
The results of this qualitative study showed a gap between the information and support that relatives to newly listed heart or lung transplant patients need and receive. The professional teams and so[...]Ultrasound to Combat Liver Tumours» europa.eu
Liver tumours are either benign or malignant; if malignant then they can be primary or secondary. In Europe, a solitary lesion in the liver is more likely to be a metastatic carcinoma than a primary [...]Complementary and Alternative medicine studies take centre stage at EuroHeartCare » escardio.org
Two abstracts show the potential for medical yoga and acupressure, in addition to pharmacological therapies, to reduce blood pressure and heart rates in patients with AF. In a third abstract, a surve[...]Robotic Hand» europa.eu
Losing the use of a limb - or losing the limb completely - can have a huge impact on a person's quality of life. Coming to terms with an impairment or disability can be an equally traumatic experienc[...]European Medicines Agency reminds companies of timeframe to submit product-information translations in Croatian» europa.eu
The European Medicines Agency reminds applicants and marketing-authorisation holders that they need to submit of translations of product information in Croatian for opinions as of April 2013.[...]Scientific guideline: guideline on the clinical development of medicinal products intended for the treatment of chronic primary immune thrombocytopenia, consultation open» europa.eu
This guideline describes the information on the clinical development to be documented when an application for a marketing authorisation for a medicinal product is made for the treatment of chronic pr[...]European & Developing Countries Clinical Trials Partnership: High-Level Conference on EDCTP2: proceedings and video available online» edctp.org
Today the European & Developing Countries Clinical Trials Partnership (EDCTP) published the report of the High-Level Conference on the second EDCTP programme (EDCTP2) and a short video on the eve[...]Simplification of submission of applications for centrally authorised medicines» europa.eu
The European Medicines Agency has simplified the process of submission of applications for centrally authorised medicines, reducing the number of applications companies now need to submit.[...]Draft guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms : consultation open» europa.eu
This guideline replaces Guideline on Modified Release Oral and Transdermal Dosage Forms Section II 9 (Pharmacokinetic and Clinical Evaluation (EMA/CPMP/EWP/280/96 Corr*)).[...]European Medicines Agency updates product information template to label medicines subject to additional monitoring and encourage adverse-reaction reporting» europa.eu
As part of the implementation of the European Union (EU) pharmacovigilance legislation, the European Medicines Agency has updated the product information template to allow easy identification of huma[...]European Medicines Agency focuses on new legislation, increased efficiency and transparency in 2013 work programme» europa.eu
The European Medicines Agency has published its work programme for 2013.[...]14 March 2013: World Kidney Day: ‘Acute kidney injury: stop kidney attack!'» europa.eu
The European Medicines Agency supports World Kidney Day, which is taking place on Thursday 14 March 2013.[...]
Periodic Report Summary 2 - NAD (Nanoparticles for therapy and diagnosis of Alzeimer disease)»
europa.eu
UNIVERSITA' DEGLI STUDI DI MILANO-BICOCCA Project context and objectives: Over three million people in the European Union (EU) have Alzheimer disease (AD), with one in 20 people over 65, and one in f[...]3D Technology in Medicine» europa.eu
Medical visualisation uses computers to create 3D images from medical imaging data sets. This is a relatively new field of science, but despite its youth, the technology has already revolutionised me[...]European Society of Cardiology responds to European Commission's Proposals for new regulation to govern medical devices» escardio.org
ESC authors have outlined five suggestions that they feel would make the EC legislation stronger: a requirement to establish the clinical efficacy of certain new high-risk devices; greater transparen[...]Revised rules on the distribution of medicinal products in the EU» europa.eu
European Commission - General Information Major developments General Information [...]Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 March 2013» europa.eu
The PRAC welcomed the appointment by the European Commission of one member and alternate each representing healthcare professionals and patient organisations.[...]Scientific guideline: Draft guideline on influenza vaccines – quality module, draft: consultation open» europa.eu
The purpose of this guideline is to provide guidance on development, manufacturing and control for Marketing Authorisation Applications for influenza vaccines. The Quality Module has been updated in [...]Questions and answers: New 'black symbol' for medicinal products» europa.eu
European Commission MEMO Brussels, 7 March 2013 What is the black symbol? The black symbol is an inverted equilateral black triangle to be included in product information for certain categories of me[...]Pharmaceuticals: New symbol to identify medicines undergoing additional monitoring» europa.eu
European Commission Press release Brussels, 7 March 2013 An inverted triangle will shortly appear on the inside leaflet of certain medicinal products on the EU market, following a legal act adopted b[...]
Periodic Report Summary - ÆRTOS (Associated European research and technology organisations)»
europa.eu
FRAUNHOFER-GESELLSCHAFT ZUR FOERDERUNG DER ANGEWANDTEN FORSCHUNG E.V The European research area net (ERA-NET) projects aim to create synergies among national research and development (R&D) progra[...]
Final Report Summary - ÆRTOS (Associated European Research and Technology Organisations)»
europa.eu
FRAUNHOFER-GESELLSCHAFT ZUR FOERDERUNG DER ANGEWANDTEN FORSCHUNG E.V The European research area net (ERA-NET) projects aim to create synergies among national research and development (R&D) progra[...]Pharmaceuticals: New symbol to identify medicines undergoing additional monitoring»
The symbol will allow patients and health care professionals to easily identify medicinal products that are undergoing additional monitoring, and its accompanying text will encourage them to report unexpected adverse reactions through national reporting systems.
Novel treatment for bone marrow cancer» europa.eu
Multiple myeloma is a form of cancer in which the plasma cells in the bone marrow grow out of control, causing damage to bones as well as predisposing patients to anaemia, infection and kidney failur[...]Public consultation starts on first guideline on medicines for the treatment of lupus erythematous» europa.eu
The European Medicines Agency has released the first guideline in the European Union on clinical investigation of medicines for the treatment of lupus erythematosus for public consultation.[...]Concept paper on the need for revision of note for guidance on clinical investigation of medicinal products for the treatment of cardiac failure, draft: consultation open» europa.eu
Chronic Heart Failure (CHF) encompasses heterogeneous groups of patients with a wide spectrum of symptoms and different causes. The CHMP Guideline on the clinical investigations of medicinal products[...]Reflection paper on quality of essential oils as active substances in herbal medicinal products/traditional herbal medicinal products, draft: consultation open» europa.eu
This reflection paper applies to essential oils used as active substances in herbal medicinal products (HMPs) both for human and veterinary use and in traditional herbal medicinal products (THMPs) fo[...]Scientific guideline: Guideline on the clinical investigation of medicinal products for the treatment of Duchenne and Becker muscular dystrophy, draft: consultation open» europa.eu
Recent advances in basic and clinical research have opened new perspectives for future therapeutic options in Duchenne and Becker muscular dystrophy (DBMD). The increasing number of clinical trials t[...]Concept paper on the need to revise the guideline on the clinical development of fixed dose combinations of medicinal products regarding dossier content requirements» europa.eu
The current guideline CHMP/EWP/240/95 Rev. 1 contains a section describing the legal basis applicable to fixed dose combination (FDC) product marketing authorisation application (MAA).[...]Scientific guideline: Guideline on the use of porcine trypsin used in the manufacture of human biological medicinal products, draft: consultation open» europa.eu
This guideline describes the information to be considered by the manufacturer of human biological medicinal products using porcine trypsin.[...]Tackling medication errors: European Medicines Agency workshop calls for coordinated EU approach» europa.eu
A close collaboration between national patient safety authorities, national competent authorities, the European Medicines Agency, and the European Commission is necessary to tackle the issue of medic[...]Scientific guideline: Concept paper on use of recovered/recycled solvents in the manufacture of herbal preparations for use in herbal medicinal products / traditional herbal medicinal products, draft: consultation open» europa.eu
This concept paper concerns the standards to be applied to recycled/recovered solvents used for extraction of herbal substances in the manufacture of herbal preparations for use in herbal medicinal p[...]28 February 2013 - Rare Disease Day: 'Rare disorders without borders' » europa.eu
The European Medicines Agency supports Rare Disease Day, which is taking place on Thursday 28 February.[...]Mining for new drugs in the ocean» europa.eu
Each time we use an antibiotic, the weaker strains of infection are killed off while the stronger, more virulent strains are left behind to multiply. In the past, this has not caused much concern, as[...]Muscle, skin and gastrointestinal problems cause a quarter of patients with heart disease and strokes to stop treatment in HPS2-THRIVE trial » escardio.org
The largest randomised study of the vitamin niacin in patients with occlusive arterial disease (narrowing of the arteries) has shown a significant increase in adverse side-effects when it is combined[...]European Medicines Agency revises three guidance documents to include orphan-related information» europa.eu
The European Medicines Agency has revised three guidance documents to include information related to orphan medicines.[...]Adjusted fees for applications to European Medicines Agency from 1 April 2013» europa.eu
The European Medicines Agency reminds applicants and marketing-authorisation holders that adjusted fees will be coming into effect on Monday 1 April 2013.[...]OECD urges countries to harmonise clinical trial regulations to boost medical research and save lives» oecd.org
Increasingly complex and inconsistent clinical trial regulations are causing delays, raising costs and leading to a decline in the number of international trials conducted by academics for non-commer[...]Regulatory and procedural guideline: Standard acute-myeloid-leukaemia paediatric investigation plan, draft: consultation open» europa.eu
The standard PIP for acute myeloid leukaemia (AML) was prepared by the Paediatric Committee with external experts in the Paediatric oncology task force of the EMA. The aim is to highlight the persist[...]Regulatory and procedural guideline: Standard rhabdomyosarcoma paediatric investigation plan, draft: consultation open» europa.eu
The standard PIP for rhabdomyosarcoma was prepared by the Paediatric Committee with external experts of the Paediatric oncology task force of the EMA. The aim is to highlight the persistent unmet the[...]Pharmaceuticals legislation in the EU: EudraLex latest version available» europa.eu
Now, you can consult the whole Pharmaceutical Legislation (Human and Veterinary) with an integrated search engine . The Eudralex V27 is similar to the EudraLex section of this web site, but it can be[...]European Medicines Agency: Meeting highlights from the Committee for Medicinal Products for Human Use 18-21 February 2013» europa.eu
This page provides an overview of the opinions adopted at the February 2013 meeting of the CHMP and other important outcomes.[...]Public consultation opens on standard paediatric investigation plans for two types of cancer in children » europa.eu
The European Medicines Agency has opened a public consultation on two standard paediatric investigation plans (PIPs) for two specific types of cancer with unmet medical needs in children, acute myelo[...]National rules for the education in Complementary Medicine approved in Italy» homeopathyeurope.org
On 7 February 2013, the State and the Regions and Autonomous Provinces Conference approved the national rules for the education in Complementary Medicine. The process which led to this important even[...]European Medicines Agency: outcomes of seven years of active support to small and medium-size businesses» europa.eu
Micro, small and medium-sized enterprises (SMEs) that are registered with the SME office of the European Medicines Agency have seen a consistent improvement in the success rate of their marketing-aut[...]Responses to the public consultation on a common logo for legally-operating online pharmacies» europa.eu
Responses to the concept paper submitted for public consultation concerning the implementing act on a common logo for legally-operating online pharmacies/retailers offering medicinal products for hum[...]Now available: Concept document - Experts Workshop on the proposal of an EU accreditation scheme for breast cancer services/European breast cancer guidelines» europa.eu
Organised by the JRC-IHCP Cancer Policy Support Group[...]Research Headlines - How European research is making kidney transplants safer» europa.eu
For those unfortunate to suffer from kidney failure, an organ transplant may seem like the best long-term treatment. But kidney transplants are loaded with risk, the most salient being the rejection [...]European Medicines Agency: Committee for paediatric medicinal products - towards more and better information on the use of medicines for children»
The Paediatric Committee (PDCO) of the European Medicines Agency released last year the first ‘5-year Report to the European Commission on the experience acquired on the Paediatric Regulation’External link icon.
Scientific guideline: Reflection paper on GCP compliance in relation to trial master files (paper and/or electronic) for management, audit and inspection of clinical trials, draft: consultation open» europa.eu
This reflection paper has been prepared to bring together the requirements of EU legislation and guidance relating to the TMF . This is deemed necessary by the EU GCP IWG Inspectors due to the numero[...]European Medicines Agency: Committee for Orphan Medicinal Products – strengthened interactions with patients and international partners»
"The European Medicines Agency’s Committee for Orphan Medicinal Products (COMP) is stepping into another stage of its role in the lifecycle of orphan medicines and in the field of rare diseases, after the first 12 years of the implementation of the Orphan-Medicinal-Product Regulation in the European Union," explains Bruno Sepodes, chair of the COMP
Nanoparticles and the Immune System»
Until recently, nature was the only "manufacturer" of molecular matter. In the last few years however, nanotechnology has entered the public consciousness, bringing together different areas of science. The technology is expected to lead to innovations that can help address many of the problems facing today's society