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TRUST News Review Pages: What is this and how to use it?
This TRUST News Page is a continuously updated, concise pharmaceutical & medical devices industry news overview, meant as an efficient, "Scrip-like" news research and review tool. It is generated by RSS feed at the moment you access this page, and is therefore always up-to-date.

 

You can select your specific news area of interest by clicking it in the Content Index Map above. You are free to bookmark or link to this page, if you deem this useful. Furthermore, each news item summary below possesses a quick link, enabling you to share the news item quickly on Twitter, LinkedIn, or Facebook.

 

Please note that TRUST can not alter or influence the messages displayed, nor is it responsible for its content. If needed, refer to the original European Medicines Agency website.

TRUST Consultancy News Topic: European Medicines Agency (EMA) - Patient safety, news and press releases

News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 July 2016
Item published on line: July 22nd, 2016 | 13:00:05 CEST +0200
Item accessed: July 25th, 2016 | 17:45:49 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/07/news_detail_002571.jsp&mid=WC0b01ac058004d5c1
Eight medicines recommended for approval; use of Truvada extended to include pre-exposure prophylaxis (PrEP) against HIV-1 infection
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News and press releases: Two new medicines for advanced kidney cancer
Item published on line: July 22nd, 2016 | 13:00:04 CEST +0200
Item accessed: July 25th, 2016 | 17:45:49 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/07/news_detail_002577.jsp&mid=WC0b01ac058004d5c1
Cabometyx and Kisplyx provide additional treatment options for patients with unmet medical need
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News and press releases: First medicine for HIV pre-exposure prophylaxis recommended for approval in the EU
Item published on line: July 22nd, 2016 | 13:00:03 CEST +0200
Item accessed: July 25th, 2016 | 17:45:49 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/07/news_detail_002578.jsp&mid=WC0b01ac058004d5c1
Truvada to enhance existing HIV prevention strategies
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News and press releases: CHMP confirms recommendations for use of Zydelig
Item published on line: July 22nd, 2016 | 13:00:02 CEST +0200
Item accessed: July 25th, 2016 | 17:45:49 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/07/news_detail_002573.jsp&mid=WC0b01ac058004d5c1
Patients should be monitored for infection and given antibiotics during and after treatment
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News and press releases: EMA recommends suspension of medicines over flawed studies at Semler Research Centre
Item published on line: July 22nd, 2016 | 13:00:01 CEST +0200
Item accessed: July 25th, 2016 | 17:45:49 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/07/news_detail_002574.jsp&mid=WC0b01ac058004d5c1
Bioequivalence studies performed at the site cannot be used to support medicines approval in the EU
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News and press releases: EMA website briefly unavailable on 25 July
Item published on line: July 22nd, 2016 | 11:30:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:49 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/07/news_detail_002576.jsp&mid=WC0b01ac058004d5c1
Website unavailable for approximately 10 minutes between 07:00 and 09:00 (UK time) on Monday 25 July due to essential maintenance
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News and press releases: Proposals to revise guidance on first-in-human clinical trials
Item published on line: July 21st, 2016 | 13:00:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:49 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/07/news_detail_002572.jsp&mid=WC0b01ac058004d5c1
Comments invited on a concept paper on changes intended to support best practices
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News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 12-14 July 2016
Item published on line: July 15th, 2016 | 16:00:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:49 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/07/news_detail_002569.jsp&mid=WC0b01ac058004d5c1
The Committee elected Helen Jukes from the United Kingdom as its vice-chair for a 3-year mandate.
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News and press releases: EMA recommends suspending the veterinary medicine Velactis used in dairy cows at the time of drying off
Item published on line: July 15th, 2016 | 16:00:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:49 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/07/news_detail_002570.jsp&mid=WC0b01ac058004d5c1
Suspension follows reports of serious adverse events in cows, including recumbency and deaths
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News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-8 July 2016
Item published on line: July 8th, 2016 | 16:00:03 CEST +0200
Item accessed: July 25th, 2016 | 17:45:49 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/07/news_detail_002567.jsp&mid=WC0b01ac058004d5c1
PRAC concludes a safety review and starts three new safety reviews
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News and press releases: PRAC concludes review of Zydelig and issues updated recommendations for use
Item published on line: July 8th, 2016 | 16:00:02 CEST +0200
Item accessed: July 25th, 2016 | 17:45:49 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/07/news_detail_002568.jsp&mid=WC0b01ac058004d5c1
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed its review of Zydelig
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News and press releases: Statement on the outcome of the UK referendum
Item published on line: July 6th, 2016 | 17:12:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:49 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/07/news_detail_002566.jsp&mid=WC0b01ac058004d5c1
EMA’s procedures and work streams continue as usual
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News and press releases: Procedural information – EMA goes electronic for PDCO opinions and subsequent EMA decisions
Item published on line: July 6th, 2016 | 11:30:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:49 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/07/news_detail_002565.jsp&mid=WC0b01ac058004d5c1
As of 1 August 2016, PDCO opinions and subsequent EMA decisions will be transmitted to applicants electronically only
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News and press releases: Infringement procedure against Roche – EMA update
Item published on line: July 4th, 2016 | 12:00:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:49 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/07/news_detail_002564.jsp&mid=WC0b01ac058004d5c1
The European Medicines Agency (EMA) has concluded its second inquiry within the framework of its infringement procedure against Roche.
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News and press releases: Strengthening interaction with academia
Item published on line: June 30th, 2016 | 16:20:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:49 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/06/news_detail_002563.jsp&mid=WC0b01ac058004d5c1
EMA consults academia in preparation of a framework of collaboration
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TRUST Consultancy News Topic: European Medicines Agency (EMA) - Withdrawn Products & Applications

Withdrawn application: Begedina, begelomab, Initial authorisation
Item published on line: July 22nd, 2016 | 13:00:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:10 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004144/wapp/Initial_authorisation/human_wapp_000214.jsp&mid=WC0b01ac058001d128

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Withdrawn application: Kyndrisa, drisapersen, Initial authorisation
Item published on line: June 30th, 2016 | 11:45:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:10 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003846/wapp/Initial_authorisation/human_wapp_000213.jsp&mid=WC0b01ac058001d128

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TRUST Consultancy News Topic: European Medicines Agency (EMA) - Meetings & Events

European Union (EU) International Organisation for Standardisation (ISO) identification of medical products (IDMP) task force meeting, European Medicines Agency, London, UK, From: 30-Jun-2016, To: 01-Jul-2016
Item published on line: July 22nd, 2016 | 17:30:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:53 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2016/07/event_detail_001309.jsp&mid=WC0b01ac058004d5c3
European Union (EU) International Organisation for Standardization (ISO) identification of medical products (IDMP) task force meeting with the representatives from the European Medicines Agency (EMA), terminology organisations, software vendors and developers of medicinal products dictionaries / databases to discuss aspects of planning, development, implementation and maintenance of the ISO IDMP standards in the EU, in line with requirements defined at international level and based on agreed EU implementation principles.
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10th anniversary of European Medicines Agency’s Patients' and Consumers' Working Party (PCWP), European Medicines Agency, London, UK, From: 14-Jun-2016, To: 14-Jun-2016
Item published on line: July 20th, 2016 | 10:57:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:53 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2016/03/event_detail_001264.jsp&mid=WC0b01ac058004d5c3
2016 marks the 10th anniversary of the European Medicines Agency’s (EMA) PCWP. A working group of patients' organisations was first created in 2003. Following endorsement of its framework of interaction by EMA’s Management Board, the working group was formalised into an official working party, the PCWP. Building on the importance of multi-stakeholder dialogue, the PCWP regularly holds its annual meetings jointly with the Healthcare Professionals’ Working Party. The PCWP is a unique platform for exchange and dialogue with patients and consumers on all issues related to medicines. The EMA is proud of the work of the PCWP and this anniversary meeting will be an opportunity to reflect on past successes and to plan for the future.
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Joint DIA/EFGCP/EMA better medicines for children conference 2016 on optimisiation of drug development for the benefit of children, European Medicines Agency, London, UK, From: 10-Oct-2016, To: 11-Oct-2016
Item published on line: July 8th, 2016 | 10:15:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:53 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2016/07/event_detail_001308.jsp&mid=WC0b01ac058004d5c3
The conference will discuss how drug development can be further optimised to the benefit of children’s health. This will include a discussion on lessons learned during the years of full operation of the European Union (EU) Paediatric Regulation, new concepts and strategies for an integrated approach at each and every step of paediatric development and sessions dedicated to specific areas of expertise such as neonatology as well as evolving concepts such as the approach to extrapolation from adult data. On day one participants will discuss more specialised and hot topic issues in five breakout sessions. Day two will discuss the holistic integrated approach and global issues. This event is organised by European Forum for Good Clinical Practice (EFGCP), with the partnership of Drug Information Association (DIA) and European Medicines Agency (EMA).
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European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting: Session on communication and information on medicines, European Medicines Agency, London, UK, From: 08-Mar-2016, To: 08-Mar-2016
Item published on line: July 6th, 2016 | 11:30:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:53 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2016/02/event_detail_001259.jsp&mid=WC0b01ac058004d5c3
This is a joint meeting with representatives from patients’, consumers’ and healthcare professionals’ organisations to promote an open debate on how information on medicines is produced and used. It aims to identify specific lines of research to stakeholders in the field of communication and information on medicines that could support future advancements to better meet the needs and expectations of patients, consumers, healthcare professionals and regulators. The objectives are to discuss findings emerging from recent information-related surveys, to recognise challenges and opportunities that can shape the production and use of medicines information and assess the role of different actors, and finally to list organisations’ and EMA’s unmet needs in relation to information and communication that can inform a ‘research agenda’.
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Second annual scientific workshop at EMA: Applying regulatory science to neonates , European Medicines Agency, London, UK, From: 12-Sep-2016, To: 13-Sep-2016
Item published on line: July 5th, 2016 | 15:38:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:53 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2016/07/event_detail_001306.jsp&mid=WC0b01ac058004d5c3
This workshop is co-sponsored by the EMA and the Critical Path Institute. It focuses on reviewing the progress and exploring new initiatives for the International Neonatal Consortium (INC), which is dedicated to accelerating the development of safe and effective therapies for neonates. One cross-cutting topic is how to enhance a research culture. Other overarching topics are precision medicine for neonates and long-term outcome measures. Therapeutic areas that will be examined include Neonatal Abstinence Syndrome (NAS) and Necrotizing Enterocolitis (NEC).
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Pharmacovigilance Risk Assessment Committee (PRAC): 4-8 July 2016, European Medicines Agency, London, UK, From: 04-Jul-2016, To: 08-Jul-2016
Item published on line: July 4th, 2016 | 18:35:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:53 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2014/03/event_detail_000899.jsp&mid=WC0b01ac058004d5c3
The Pharmacovigilance Risk Assessment Committee (PRAC) is the committee that is responsible for assessing all aspects of the risk management of medicines for human use.
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Healthcare Professionals' Organisations Working Party (HCPWP) workshop with academia, European Medicines Agency, London, UK, From: 15-Jun-2016, To: 15-Jun-2016
Item published on line: June 30th, 2016 | 16:22:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:53 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2016/06/event_detail_001291.jsp&mid=WC0b01ac058004d5c3
The European Union (EU) Medicines Agencies Network Strategy to 2020 calls for sound collaboration between the network and the academic world to ensure that innovative medicines can be optimally developed for the benefit of all European citizens. A strong partnership between regulators and academia is indispensable for a proactive process to support innovation and channel it into the continuous evolution of regulatory science. This workshop is the culmination of the consultation process to define a framework for collaboration based on robust foundations. The specific objectives of the workshop are to collectively review the status quo, present different perspectives and expectations, and discuss the main pillars of the framework.
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2016 annual workshop of the European network of paediatric research (Enpr-EMA) at the European Medicines Agency, European Medicines Agency, London, UK, From: 02-Jun-2016, To: 03-Jun-2016
Item published on line: June 28th, 2016 | 18:30:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:53 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2016/04/event_detail_001279.jsp&mid=WC0b01ac058004d5c3
The first day of the workshop is an open meeting to all stakeholders, including patient and parent organisations, network representatives, pharmaceutical industry staff responsible for paediatric studies and regulators. The main tocpics of the workshop this year will be the deliverables of the working groups and the implementation of the new Clinical Trial Regulation with a focus on ethics related issues. The second day is dedicated to members of Enpr-EMA and its coordinating group.
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European Medicines Agency Human Scientific Committees' Working Party with Patients’ and Consumers’ Organisations (PCWP) meeting, European Medicines Agency, London, UK, From: 14-Jun-2016, To: 14-Jun-2016
Item published on line: June 28th, 2016 | 16:00:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:53 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2016/06/event_detail_001289.jsp&mid=WC0b01ac058004d5c3
This PCWP meeting welcomes the new members and representatives for the 2016 – 2019 mandate. Updates will be given on the EMA initiatives to support and accelerate early access: adaptive pathways and the PRIME initiative. Also to be discussed is the proactive publication of clinical study reports; the EUPATI guidance documents will be presented and feedback will be given from the scientific committees.
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TRUST Consultancy News Topic: European Medicines Agency (EMA) - Ongoing public consultations

Draft European Union herbal monograph on Allium sativum L., bulbus, draft: consultation open
Item published on line: July 25th, 2016 | 16:00:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:56 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500210926

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Scientific guideline: Draft guideline on the higher-tier testing of veterinary medicinal products to dung fauna, draft: consultation open
Item published on line: July 25th, 2016 | 15:45:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:56 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500210930
Dung, especially from larger mammals, makes up a complex and highly dynamic ecosystem within a small environmental scale. This guideline is intended to provide guidance on how to investigate the environmental effects of veterinary medicines containing antiparasitic substances in higher tier laboratory tests and field studies, in situations where the initial Tier A risk assessment indicates a risk to dung flies or beetles. The guideline aims to provide harmonisation of the study design for an easier interpretation and comparison of the results.
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Scientific guideline: Draft guideline on approach towards harmonisation of withdrawal periods, draft: consultation open
Item published on line: July 25th, 2016 | 15:20:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:56 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500210929
In January 2014 the CVMP published a concept paper (EMA/CVMP/SWP/285070/2013) proposing a revision of the Note for guidance: approach towards harmonisation of withdrawal periods, in order to look again at the approach used for considering residues present at levels below the limit of quantification (LOQ). The concept paper noted that the original Note for guidance recommends that a value of half of the limit of quantification should be applied to data points below the limit of quantification, but that since publication of the Note for guidance, more sophisticated methods for dealing with levels below the limit of quantification have become available, such as the maximum likelihood approach (i.e. determining the depletion curve that would maximise the likelihood of the observed data).
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Draft European Union herbal monograph on Glycine max (L.) Merr., oleum, draft: consultation open
Item published on line: July 25th, 2016 | 13:30:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:56 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500210922

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Scientific guideline: Draft stem cell-based products for veterinary use: specific questions on tumorigenicity to be addressed by Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT), draft: consultation open
Item published on line: July 25th, 2016 | 12:40:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:56 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500210916
Since several years now, CVMP members are regularly encountered by novel therapies. Amongst these the use of stem cells, in particular mesenchymal stem cells (MSCs), in the veterinary sector is increasing, raising several challenging questions for users, manufacturers and authorities. One of the obstacles to using stem cells as the basis for regenerative medicine therapies appears to be their potential capacity to become tumorigenic.
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Scientific guideline: Draft stem cell-based products for veterinary use: specific questions on target animal safety to be addressed by Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT), draft: consultation open
Item published on line: July 25th, 2016 | 12:40:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:56 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500210915
Cell-based medicinal products (CBMP) are heterogeneous with regard to the origin and type of cells and to the complexity of the product. Cells may be self-renewing stem cells, more committed progenitor cells or terminally differentiated cells exerting a specific defined physiological function.
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Scientific guideline: Concept paper for the revision of the guideline on anticoccidials used for the therapy of coccidiosis in chickens, turkeys and geese, draft: consultation open
Item published on line: July 25th, 2016 | 11:30:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:56 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500210913
The guideline providing specific requirements with respect of the documentation of the efficacy of new veterinary medicinal products developed for therapy of coccidiosis came into effect in 1993. In 2014, a review of current CVMP guideline outlined in the ‘Draft 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’ (EMA/CHMP/CVMP/JEG-20 3Rs/704685/2012) took place.
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Scientific guideline: Concept paper on revision of the current guideline on the summary of product characteristics for antimicrobial products, draft: consultation open
Item published on line: July 25th, 2016 | 11:29:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:56 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500210914
The current guideline on the summary of product characteristics (SPC) for antimicrobial products was developed during 2001-2002 by the EWP and came into effect on 11 June 2003. The guideline was revised by SAGAM (now AWP) during 2006 and 2007 and the revised guideline came into effect on 1 May 2008 (EMEA/CVMP/SAGAM/383441/2005)(1). Since then there have been further significant developments in principles of antimicrobial therapy and antimicrobial resistance and various initiatives have been taken by CVMP.
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Scientific guideline: Concept paper on the revision of the 'Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products', draft: consultation open
Item published on line: July 21st, 2016 | 13:00:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:56 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500210825
Guidance for progression from the conduct of non-clinical studies to clinical trials for investigational medicinal products in humans are addressed in ICH M3(R2) as well as in the EMA ‘Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products’ published in 2007. The EMA guideline mainly addresses the non-clinical aspects of drug development and reflects the practice at the time it was developed which focused on a single ascending dose design for first-in-human (FIH) trials. Since then, integration of the non-clinical data available before FIH administrations and the PK, PD and human safety data emerging during a trial has evolved. Consequently, many FIH trials are now performed with integrated protocols potentially combining different study parts. This concept paper outlines aspects to be considered in revising the current guideline to address the evolution of FIH clinical trials protocols.
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Call for scientific data for the systematic review of the monograph on Polypodium vulgare L., rhizoma, draft: consultation open
Item published on line: July 15th, 2016 | 10:00:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:56 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500210137
Submission period: 15 July 2016 - 15 October 2016
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Call for scientific data for the systematic review of the monograph on Commiphora molmol Engler, gummi-resina, draft: consultation open
Item published on line: July 15th, 2016 | 10:00:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:56 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500210135
Submission period: 15 July 2016 - 15 October 2016
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Call for scientific data for the systematic review of the monograph on Oenothera biennis L.; Oenothera lamarckiana L., oleum, draft: consultation open
Item published on line: July 15th, 2016 | 10:00:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:56 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500210136
Submission period: 15 July 2016 - 15 October 2016
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Call for scientific data for the systematic review of the monograph on Trigonella foenum-graecum L., semen, draft: consultation open
Item published on line: July 15th, 2016 | 10:00:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:56 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500210138
Submission period: 15 July 2016 - 15 October 2016
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Scientific guideline: Draft concept paper on guidance for the collection of data on antimicrobial consumption by species from national data collection systems, draft: consultation open
Item published on line: July 13th, 2016 | 18:25:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:56 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500210217
The European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) activity work stream on the collection of antimicrobial consumption data by animal species aims to foster the collection of harmonised and standardised data in the European Union/European Economic Area (EU/EEA). One of the objectives of this work stream is to provide guidance on the collection of antimicrobial consumption data per animal species.
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Scientific guideline: Draft implementation strategy of ICH Q3D guideline, draft: consultation open
Item published on line: July 12th, 2016 | 11:35:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:56 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500210121
The purpose of this document is to describe the practical implementation of ICH Q3D Guideline for Elemental Impurities in the European context.
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Scientific guideline: Draft guideline on the clinical evaluation of direct acting antivirals for the treatment of chronic hepatitis, draft: consultation open
Item published on line: July 7th, 2016 | 13:30:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:56 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500209917
This draft guideline replaces the CHMP’s Guideline on the clinical evaluation of direct acting antiviral agents intended for treatment of chronic hepatitis C (EMEA/CHMP/EWP/30039/2008). There have been considerable developments in the field of hepatitis C virus (HCV) therapy since the adoption of EMEA/CHMP/EWP/30039/2008. Since 2013 direct acting antivirals (DAAs) have been approved for the treatment of chronic HCV infections within interferon-free combination regimens. Therefore this revision of the prior guidance concerns the development of DAA-only regimens.
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Scientific guideline: Draft guideline on the clinical investigation of medicinal products for the treatment of axial spondyloarthritis - Revision 1, draft: consultation open
Item published on line: July 1st, 2016 | 10:30:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:56 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500209471
This document is a revision of the guideline on clinical investigation of medicinal products for the treatment of ankylosing spondylitis (CPMP/EWP/4891/03) which came into effect in May 2009. It should be considered as general guidance on the development of medicinal products for the treatment of axial spondyloarthritis and should be read in conjunction with other European and ICH guidelines which may apply to this disease area and patient population.
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Scientific guideline: Draft guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials, draft: consultation open
Item published on line: July 1st, 2016 | 01:00:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:56 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500209618
The following guideline is to be seen in connection with Regulation (EU) No. 536/2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, which came into force on June 20, 2014. Since clinical trials can be designed as multi-centre studies potentially involving different member states, it is the aim of this guideline to define harmonised requirements for the documentation to be submitted throughout the European Union.
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Scientific guideline: Stem cell -based products for veterinary use: Specific questions on extraneous agents to be addressed by Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT), draft: consultation open
Item published on line: June 27th, 2016 | 16:40:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:56 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500209367
Cell-based medicinal products (CBMP) are heterogeneous with regard to the origin and type of cells and to the complexity of the product.
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Scientific guideline: Guideline on user safety of topically administered veterinary medicinal products, draft: consultation open
Item published on line: June 27th, 2016 | 16:40:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:56 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500209366
The guideline on user safety of topically administered products has been written to provide specific guidance and advice on how user risk assessments should be conducted for such products.
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TRUST Consultancy News Topic: European Medicines Agency (EMA)
Pending EC decisions and European Public Assessment Reports (EPARs): Human medicinal products

Human medicines European public assessment report (EPAR): Krystexxa, pegloticase, Revision: 3, Withdrawn
Item published on line: July 22nd, 2016 | 18:30:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:00 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002208/human_med_001591.jsp&mid=WC0b01ac058001d124

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Pending EC decision: Truberzi, eluxadoline, Opinion date: 21-Jul-2016
Item published on line: July 22nd, 2016 | 13:00:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:00 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004098/smops/Positive/human_smop_001011.jsp&mid=WC0b01ac058001d127

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Pending EC decision: Ameluz, 5-aminolevulinic acid hydrochloride, Opinion date: 21-Jul-2016
Item published on line: July 22nd, 2016 | 13:00:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:00 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002204/smops/Positive/human_smop_001014.jsp&mid=WC0b01ac058001d127

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Pending EC decision: Cabometyx , cabozantinib, Opinion date: 21-Jul-2016
Item published on line: July 22nd, 2016 | 13:00:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:00 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004163/smops/Positive/human_smop_001016.jsp&mid=WC0b01ac058001d127

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Pending EC decision: Orencia, abatacept, Opinion date: 21-Jul-2016
Item published on line: July 22nd, 2016 | 13:00:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:00 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000701/smops/Positive/human_smop_001013.jsp&mid=WC0b01ac058001d127

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Pending EC decision: Sialanar, glycopyrronium bromide, Opinion date: 21-Jul-2016
Item published on line: July 22nd, 2016 | 13:00:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:00 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003883/smops/Positive/human_smop_000976.jsp&mid=WC0b01ac058001d127

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Pending EC decision: Onivyde, irinotecan, Opinion date: 21-Jul-2016
Item published on line: July 22nd, 2016 | 13:00:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:00 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004125/smops/Positive/human_smop_001007.jsp&mid=WC0b01ac058001d127

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Pending EC decision: Kisplyx, lenvatinib, Opinion date: 21-Jul-2016
Item published on line: July 22nd, 2016 | 13:00:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:00 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004224/smops/Positive/human_smop_001017.jsp&mid=WC0b01ac058001d127

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Pending EC decision: Zydelig, idelalisib, Opinion date: 21-Jul-2016
Item published on line: July 22nd, 2016 | 13:00:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:00 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003843/smops/Positive/human_smop_000938.jsp&mid=WC0b01ac058001d127

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Pending EC decision: Truvada, emtricitabine / tenofovir disoproxil, Opinion date: 21-Jul-2016
Item published on line: July 22nd, 2016 | 13:00:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:00 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000594/smops/Positive/human_smop_001012.jsp&mid=WC0b01ac058001d127

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Pending EC decision: Thorinane, enoxaparin sodium, Opinion date: 21-Jul-2016
Item published on line: July 22nd, 2016 | 13:00:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:00 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003795/smops/Positive/human_smop_001010.jsp&mid=WC0b01ac058001d127

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Pending EC decision: Inhixa, enoxaparin sodium, Opinion date: 21-Jul-2016
Item published on line: July 22nd, 2016 | 13:00:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:00 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004264/smops/Positive/human_smop_001009.jsp&mid=WC0b01ac058001d127

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Pending EC decision: Imbruvica, ibrutinib, Opinion date: 21-Jul-2016
Item published on line: July 22nd, 2016 | 13:00:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:00 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003791/smops/Positive/human_smop_001015.jsp&mid=WC0b01ac058001d127

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Pending EC decision: Tenofovir disoproxil Zentiva, tenofovir disoproxil, Opinion date: 21-Jul-2016
Item published on line: July 22nd, 2016 | 13:00:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:00 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004120/smops/Positive/human_smop_001018.jsp&mid=WC0b01ac058001d127

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Pending EC decision: Xalkori, crizotinib, Opinion date: 21-Jul-2016
Item published on line: July 22nd, 2016 | 13:00:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:00 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002489/smops/Positive/human_smop_001008.jsp&mid=WC0b01ac058001d127

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Human medicines European public assessment report (EPAR): Imvanex, modified vaccinia Ankara virus, Revision: 8, Authorised
Item published on line: July 21st, 2016 | 16:16:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:00 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002596/human_med_001666.jsp&mid=WC0b01ac058001d124

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Human medicines European public assessment report (EPAR): Jentadueto, linagliptin / metformin hydrochloride, Revision: 10, Authorised
Item published on line: July 21st, 2016 | 11:20:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:00 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002279/human_med_001574.jsp&mid=WC0b01ac058001d124

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Human medicines European public assessment report (EPAR): Afinitor, everolimus, Revision: 17, Authorised
Item published on line: July 21st, 2016 | 10:15:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:00 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001038/human_med_000633.jsp&mid=WC0b01ac058001d124

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Human medicines European public assessment report (EPAR): Sprycel, dasatinib, Revision: 27, Authorised
Item published on line: July 20th, 2016 | 17:37:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:00 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000709/human_med_001062.jsp&mid=WC0b01ac058001d124

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Human medicines European public assessment report (EPAR): ATryn, antithrombin alfa, Revision: 12, Authorised
Item published on line: July 20th, 2016 | 17:17:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:00 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000587/human_med_000658.jsp&mid=WC0b01ac058001d124

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Human medicines European public assessment report (EPAR): Fabrazyme, agalsidase beta, Revision: 22, Authorised
Item published on line: July 20th, 2016 | 16:59:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:00 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000370/human_med_000784.jsp&mid=WC0b01ac058001d124

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Human medicines European public assessment report (EPAR): Synjardy, empagliflozin / metformin, Revision: 4, Authorised
Item published on line: July 20th, 2016 | 15:25:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:00 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003770/human_med_001865.jsp&mid=WC0b01ac058001d124

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Human medicines European public assessment report (EPAR): Benlysta, belimumab, Revision: 13, Authorised
Item published on line: July 20th, 2016 | 14:22:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:00 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002015/human_med_001466.jsp&mid=WC0b01ac058001d124

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Human medicines European public assessment report (EPAR): Protopic, tacrolimus, Revision: 21, Authorised
Item published on line: July 20th, 2016 | 12:54:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:00 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000374/human_med_001000.jsp&mid=WC0b01ac058001d124

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Human medicines European public assessment report (EPAR): Komboglyze, saxagliptin / metformin hydrochloride, Revision: 11, Authorised
Item published on line: July 20th, 2016 | 12:28:00 CEST +0200
Item accessed: July 25th, 2016 | 17:45:00 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002059/human_med_001516.jsp&mid=WC0b01ac058001d124

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