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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) 23-26 May 2016
Item published on line: May 27th, 2016 | 13:00:01 CEST +0200
Item accessed: May 28th, 2016 | 09:46:53 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/05/news_detail_002535.jsp&mid=WC0b01ac058004d5c1
Six medicines, including two combination therapies for chronic hepatitis C, recommended for approval
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News and press releases: Two new combination therapies against chronic hepatitis C
Item published on line: May 27th, 2016 | 13:00:00 CEST +0200
Item accessed: May 28th, 2016 | 09:46:53 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/05/news_detail_002537.jsp&mid=WC0b01ac058004d5c1
Direct-acting antivirals Epclusa and Zepatier recommended for approval
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News and press releases: Improving safety of first-in-human clinical trials
Item published on line: May 27th, 2016 | 11:00:00 CEST +0200
Item accessed: May 28th, 2016 | 09:46:53 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/05/news_detail_002538.jsp&mid=WC0b01ac058004d5c1
EMA starts EU-wide reflection on necessary changes to best practices
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News and press releases: European expert group proposes reduction of use in animals of last resort antibiotic colistin to manage risk of resistance
Item published on line: May 26th, 2016 | 17:00:00 CEST +0200
Item accessed: May 28th, 2016 | 09:46:53 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/05/news_detail_002536.jsp&mid=WC0b01ac058004d5c1
Updated advice is released for public consultation
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News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 17-19 May 2016
Item published on line: May 20th, 2016 | 16:00:00 CEST +0200
Item accessed: May 28th, 2016 | 09:46:53 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/05/news_detail_002534.jsp&mid=WC0b01ac058004d5c1
CVMP opinions on veterinary medicinal products
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News and press releases: Accessing key EMA information on human medicines
Item published on line: May 20th, 2016 | 11:00:00 CEST +0200
Item accessed: May 28th, 2016 | 09:46:53 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/05/news_detail_002532.jsp&mid=WC0b01ac058004d5c1
New guide to information about medicines evaluated by the Agency
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News and press releases: Progress in science, medicine and health
Item published on line: May 17th, 2016 | 17:00:00 CEST +0200
Item accessed: May 28th, 2016 | 09:46:53 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/05/news_detail_002531.jsp&mid=WC0b01ac058004d5c1
EMA publishes 2015 annual report
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News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 May 2016
Item published on line: May 13th, 2016 | 16:00:00 CEST +0200
Item accessed: May 28th, 2016 | 09:46:53 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/05/news_detail_002528.jsp&mid=WC0b01ac058004d5c1
PRAC concludes on meta-analysis on the risk of inhibitor development in severe haemophilia patients receiving recombinant factor VIII products
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News and press releases: European Medicines Agency closed 16 May 2016
Item published on line: May 13th, 2016 | 10:00:00 CEST +0200
Item accessed: May 28th, 2016 | 09:46:53 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/05/news_detail_002530.jsp&mid=WC0b01ac058004d5c1
EMA closed from 18:30 on Friday 13 May until 7:30 on Tuesday 17 May 2016
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News and press releases: Can regulators influence the affordability of medicines?
Item published on line: May 12th, 2016 | 11:00:00 CEST +0200
Item accessed: May 28th, 2016 | 09:46:53 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/05/news_detail_002529.jsp&mid=WC0b01ac058004d5c1
Top EMA and national authority representatives discuss options in a NEJM article
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News and press releases: Supporting innovative SMEs as major drivers of new pharmaceutical developments
Item published on line: May 11th, 2016 | 11:45:00 CEST +0200
Item accessed: May 28th, 2016 | 09:46:53 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/05/news_detail_002525.jsp&mid=WC0b01ac058004d5c1
EMA publishes report on the first ten years of its SME initiative
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News and press releases: European Medicines Agency closed 5-9 May 2016
Item published on line: May 3rd, 2016 | 16:30:00 CEST +0200
Item accessed: May 28th, 2016 | 09:46:53 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/05/news_detail_002527.jsp&mid=WC0b01ac058004d5c1
EMA closed from 18:30 on Wednesday 4 May until 7:30 on Tuesday 10 May 2016
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News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 April 2016
Item published on line: April 29th, 2016 | 13:00:04 CEST +0200
Item accessed: May 28th, 2016 | 09:46:53 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/04/news_detail_002518.jsp&mid=WC0b01ac058004d5c1
Six medicines, including one new antibacterial recommended for authorisation in the EU; antiseptic gel for newborns receives positive scientific opinion for use outside the EU
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News and press releases: Boosting care for newborn babies in low-income countries
Item published on line: April 29th, 2016 | 13:00:03 CEST +0200
Item accessed: May 28th, 2016 | 09:46:53 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/04/news_detail_002524.jsp&mid=WC0b01ac058004d5c1
Umbipro to help prevent umbilical cord infections
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News and press releases: New medicine to help in the fight against antimicrobial resistance
Item published on line: April 29th, 2016 | 13:00:02 CEST +0200
Item accessed: May 28th, 2016 | 09:46:53 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/04/news_detail_002523.jsp&mid=WC0b01ac058004d5c1
Zavicefta is recommended for approval for patients with limited treatment options.
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News and press releases: New treatment for rare white blood cell cancer
Item published on line: April 29th, 2016 | 13:00:01 CEST +0200
Item accessed: May 28th, 2016 | 09:46:53 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/04/news_detail_002522.jsp&mid=WC0b01ac058004d5c1
Treatment of follicular lymphoma to be added to Gazyvaro’s approved uses
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News and press releases: EMA completes review of inhaled corticosteroids for chronic obstructive pulmonary disease
Item published on line: April 29th, 2016 | 13:00:00 CEST +0200
Item accessed: May 28th, 2016 | 09:46:53 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/04/news_detail_002521.jsp&mid=WC0b01ac058004d5c1
Review finds no differences between products in risk of pneumonia
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TRUST Consultancy News Topic: European Medicines Agency (EMA) - Withdrawn Products & Applications

Withdrawn application: Opsiria, sirolimus, Initial authorisation
Item published on line: May 27th, 2016 | 13:00:00 CEST +0200
Item accessed: May 28th, 2016 | 09:46:01 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003978/wapp/Initial_authorisation/human_wapp_000209.jsp&mid=WC0b01ac058001d128

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Withdrawn application: Xegafri, rociletinib, Initial authorisation
Item published on line: May 27th, 2016 | 13:00:00 CEST +0200
Item accessed: May 28th, 2016 | 09:46:01 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004053/wapp/Initial_authorisation/human_wapp_000208.jsp&mid=WC0b01ac058001d128

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

European Medicines Agency-Industry Stakeholders Platform second meeting on paediatric medicines, European Medicines Agency, London, UK, From: 15-Apr-2016, To: 15-Apr-2016
Item published on line: May 27th, 2016 | 16:35:00 CEST +0200
Item accessed: May 28th, 2016 | 09:46:59 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2016/04/event_detail_001276.jsp&mid=WC0b01ac058004d5c3
The European Medicines Agency (EMA) is hosting the second EMA-Industry Stakeholders Platform meeting on paediatric medicines. This meeting will serve as stage to discuss among other topics the experience, so far, with paediatric standard paediatric-investigation plans (PIPs), the pilot on early interaction on paediatric development and changes to the summary report and electronic submission.
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Workshop on single-arm trials (SAT) in oncology, European Medicines Agency, London, UK, From: 30-Jun-2016, To: 30-Jun-2016
Item published on line: May 20th, 2016 | 14:15:00 CEST +0200
Item accessed: May 28th, 2016 | 09:46:59 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2016/05/event_detail_001285.jsp&mid=WC0b01ac058004d5c3
Single-arm trials (SATs) have led to regulatory approval of oncology products in case of dramatic activity in well-defined populations with high unmet medical need. Further, when randomized-controlled trials are not possible, SATs augmented with statistical approaches may become the standard basis of evidence of efficacy for new applications. However, what constitutes dramatic activity and high unmet medical need is often debated and there is no regulatory guidance on cancer drug development in these situations and how to manage the remaining uncertainties optimally. This workshop will debate the experience gained with these types of approvals, the strengths and weaknesses of different approaches, explore the views of different stakeholders and underlying principles, and will discuss the need and appropriateness for further regulatory guidance.
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Workshop on immunogenicity assessment of biotechnology-derived therapeutic proteins, European Medicines Agency, London, UK, From: 09-Mar-2016, To: 09-Mar-2016
Item published on line: May 20th, 2016 | 10:49:00 CEST +0200
Item accessed: May 28th, 2016 | 09:46:59 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2016/01/event_detail_001257.jsp&mid=WC0b01ac058004d5c3
The workshop is held to discuss the draft Committee for Medicinal Products for Human Use/Biosimilar Medicinal Products Working Party (BMWP) guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins. Participants will include experts from the BMWP, the Biostatistics Working Party (BWP), other regulatory authorities and stakeholders who provided comments on the draft guideline as well as specifically invited interested parties.
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Workshops for micro, small and medium-sized enterprises: focus on non-clinical aspects, European Medicines Agency, London, UK, From: 03-Oct-2016, To: 03-Oct-2016
Item published on line: May 19th, 2016 | 16:10:00 CEST +0200
Item accessed: May 28th, 2016 | 09:46:59 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2016/05/event_detail_001284.jsp&mid=WC0b01ac058004d5c3
This workshop aims to provide an overview of non-clinical data requirements for the authorisation of medicinal products, how to address these during the medicinal product development, and detail the approaches for biological and advanced therapy medicinal products. A regulatory brief on the new PRIME scheme is also included in the programme.
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Third industry stakeholder platform on the operation of the centralised procedure for human medicinal products, European Medicines Agency, London, UK, From: 21-Apr-2016, To: 21-Apr-2016
Item published on line: May 19th, 2016 | 13:02:00 CEST +0200
Item accessed: May 28th, 2016 | 09:46:59 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2016/04/event_detail_001278.jsp&mid=WC0b01ac058004d5c3
The European Medicines Agency (EMA) is hosting the third meeting of its industry stakeholder platform on the operation of the centralised procedure, which was established in April 2015. The objective of this series of semi-annual meetings between regulators and representatives of industry stakeholder organisations is to provide an opportunity for both general updates and more focused discussions on specific processes or issues to support continuous improvement, and generally to foster a constructive dialogue with industry stakeholders. The third meeting will address management of accelerated assessment, pre-submission dialogue, improvements in the post-authorisation management as well as first experience with requests for PRIME.
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Multi-stakeholder advanced therapy medicinal products (ATMPs) expert meeting: exploring solutions to foster ATMPs’ development and patient access in Europe, European Medicines Agency, London, UK, From: 27-May-2016, To: 27-May-2016
Item published on line: May 13th, 2016 | 14:28:00 CEST +0200
Item accessed: May 28th, 2016 | 09:46:59 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2016/05/event_detail_001283.jsp&mid=WC0b01ac058004d5c3
With representation from the European medicines regulatory network and the European Commission, EMA is organising this multi-stakeholder expert meeting on ATMPs to address challenges identified to pharmaceutical innovation in Europe. The aim is to understand the current European Union environment for ATMPs and to explore new or different ways for stimulating innovation, facilitating European research and development and accelerating patients’ access to high quality, safe and efficacious ATMPs. EMA has invited a broad range of experienced stakeholders involved throughout the ATMP medicines’ life cycle, from early research and development through to the product supply chain. This includes experienced academics, incubator managers, investors, healthcare professionals, patients, industry representatives (from micro-, small- and medium-sized as well as large companies) and health-technology-assessment bodies.
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Targeted consultation on the guideline for development of new medicinal products for the treatment of rheumatoid arthritis, European Medicines Agency, London, UK, From: 07-Jun-2016, To: 07-Jun-2016
Item published on line: May 3rd, 2016 | 15:30:00 CEST +0200
Item accessed: May 28th, 2016 | 09:46:59 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2016/05/event_detail_001282.jsp&mid=WC0b01ac058004d5c3
In the frame of public consultation on the revision of the guideline on clinical investigation of medicinal products other than non-steroidal anti-inflammatory drugs (NSAIDs) for treatment of rheumatoid arthritis, the European Medicines Agency is hosting a meeting to supplement the ongoing debate.
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Seventh industry stakeholder platform: operation of European Union pharmacovigilance legislation, European Medicines Agency, London, UK, From: 04-Apr-2016, To: 04-Apr-2016
Item published on line: April 29th, 2016 | 15:06:00 CEST +0200
Item accessed: May 28th, 2016 | 09:46:59 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2016/04/event_detail_001274.jsp&mid=WC0b01ac058004d5c3
The seventh platform meeting with industry stakeholder associations on the implementation and operation of the European Pharmacovigilance Legislation will take place at the European Medicines Agency (EMA) on 4 April 2016. Discussion at the meeting will include a roadmap for periodic safety update reports (PSURs), scientific advice for post-authorisation studies and signal management. The agenda of the meeting is published on the EMA website.
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TRUST Consultancy News Topic: European Medicines Agency (EMA) - Ongoing public consultations

Scientific guideline: Draft guideline on the plant testing strategy for veterinary medicinal products, draft: consultation open
Item published on line: May 27th, 2016 | 17:00:00 CEST +0200
Item accessed: May 28th, 2016 | 09:47:05 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500207463
Plant toxicity tests are used in the terrestrial environmental risk assessment of veterinary medicinal products (VMPs) as described in the VICH guideline on environmental impact assessment for veterinary medicinal products Phase II (CVMP/VICH/790/2003) (CVMP/VICH, 2005).
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Scientific guideline: Draft reflection paper on non-spontaneous adverse event reports (peer-reviewed literature, internet and social media), draft: consultation open
Item published on line: May 27th, 2016 | 17:00:00 CEST +0200
Item accessed: May 28th, 2016 | 09:47:05 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500207464
It is acknowledged that the topics of reports published in peer-reviewed worldwide literature and information on adverse events from the internet are introduced in Volume 9B of the Rules Governing Medicinal Products in the European Union (EU). However detailed guidance on handling such reports is not given and interpretation of requirements has been variable between national competent authorities (NCAs) to date.
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Scientific guideline: Updated advice on the use of colistin products in animals within the European Union: development of resistance and possible impact on human and animal health, draft: consultation open
Item published on line: May 26th, 2016 | 17:00:00 CEST +0200
Item accessed: May 28th, 2016 | 09:47:05 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500207233
Colistin is an antibacterial agent of the polymyxin class. Following the discovery of a gene (called mcr-1) that causes bacteria to become resistant to colistin, the European Commission requested the European Medicines Agency to update its 2013 advice on the use of colistin in animals. This updated advice provides an analysis of colistin toxicity, susceptibility testing, activity and resistance mechanisms, risk profile (based on consumption patterns and epidemiology), and risk management options.
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Scientific guideline: Draft reflection paper on the dissolution specification for generic oral immediate release products, draft: consultation open
Item published on line: May 13th, 2016 | 14:44:00 CEST +0200
Item accessed: May 28th, 2016 | 09:47:05 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500206407
This document discusses the suitability of the dissolution method and the specifications for in vitro dissolution of orally administered generic drug products with immediate release characteristics.
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Inventory of paediatric therapeutic needs - Respiratory
Item published on line: May 11th, 2016 | 16:20:00 CEST +0200
Item accessed: May 28th, 2016 | 09:47:05 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500206082

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Scientific guideline: Draft information in the package leaflet for fructose and sorbitol in the context of the revision of the guideline on 'Excipients in the label and package leaflet of medicinal products for human use' (CPMP/463/00 Rev. 1), draft: consultation open
Item published on line: May 4th, 2016 | 14:00:00 CEST +0200
Item accessed: May 28th, 2016 | 09:47:05 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500206001
This document supports the revision of the European Commission Guideline on 'Excipients in the label and package leaflet of medicinal products for human use' with regard to fructose and sorbitol, which are used as excipients in a variety of oral (tablets, capsules, suspensions) and topical formulations (creams, emulsions). Sorbitol (and rarely fructose) is also used as a protein/peptide stabiliser in some medicinal products for parenteral use such as blood products (immunoglobulins) and vaccines.
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Scientific guideline: Draft information in the package leaflet for fragrances containing allergens in the context of the revision of the guideline on 'Excipients in the label and package leaflet of medicinal products for human use' (CPMP/463/00 Rev. 1), draft: consultation open
Item published on line: May 4th, 2016 | 14:00:00 CEST +0200
Item accessed: May 28th, 2016 | 09:47:05 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500206000
This document supports the revision of the European Commission Guideline on 'Excipients in the label and package leaflet of medicinal products for human use' with regard to fragrance allergens. The European Commission designated 26 fragrances as allergens requiring labelling in cosmetic and detergent products if the concentration of the designated ingredient exceeds 100 parts per million (ppm) for a rinse-off product and 10 ppm for a leave-on product. Some of these allergens are also used in topically applied medicinal products. Since topically applied medicinal products may be applied on a more sensitive skin (if damaged), a zero threshold should be applied.
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Scientific guideline: Draft information in the package leaflet for aspartame in the context of the revision of the guideline on 'Excipients in the label and package leaflet of medicinal products for human use' (CPMP/463/00 Rev. 1), draft: consultation open
Item published on line: May 4th, 2016 | 14:00:00 CEST +0200
Item accessed: May 28th, 2016 | 09:47:05 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500205999
This document supports the revision of the European Commission Guideline on 'Excipients in the label and package leaflet of medicinal products for human use' with regard to aspartame. Aspartame (L-aspartyl L-phenylalanine methylester) is an artificial sweetener used to substitute sugar in food and beverages and to make pharmaceuticals more palatable.The main reason for reassessing the information on the package leaflet was new scientific data becoming available through the European Food Safety Authority’s full re-evaluation of the safety of aspartame as a food additive in the EU (E951) published in December 2013. The EFSA assessment served as the basis for the present evaluation of aspartame as excipient in medicinal products.
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Scientific guideline: Concept paper on the revision of the 'Guideline on the environmental risk assessment of medicinal products for human use', draft: consultation open
Item published on line: May 4th, 2016 | 10:00:00 CEST +0200
Item accessed: May 28th, 2016 | 09:47:05 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500205987
In 2006, the 'Guideline on Environmental Risk Assessment of Medicinal Products for Human Use' (EMEA/CHMP/SWP/4447/00) was published. The purpose of the guideline is to describe the assessment of potential environmental risks of human medicinal products including considerations for risk mitigation measures to limit their impact on the environment. Minor, editorial, changes have been included at later stages in the current version (EMEA/CHMP/SWP/4447/00 Corr. 2). A Questions and Answer document (EMA/CHMP/SWP/44609/2010) to the Guideline was released in 2011, and has been updated recently.
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Scientific guideline: Draft guideline on good pharmacogenomic practice, draft: consultation open
Item published on line: May 2nd, 2016 | 12:15:00 CEST +0200
Item accessed: May 28th, 2016 | 09:47:05 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500205758
The aim of this guideline is to lay out the requirements related to the choice of appropriate genomic methodologies during the development and life-cycle of a drug.
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Scientific guideline: Draft Everolimus tablets 0.25, 0.5, 0.75 and 1mg; 2.5, 5 and 10mg, dispersible tablets 0.1 and 0.25mg; 2, 3 and 5mg product-specific bioequivalence guidance, draft: consultation open
Item published on line: May 2nd, 2016 | 10:00:00 CEST +0200
Item accessed: May 28th, 2016 | 09:47:05 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500205726

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Scientific guideline: Draft Fingolimod capsules 0.5mg product-specific bioequivalence guidance, draft: consultation open
Item published on line: May 2nd, 2016 | 10:00:00 CEST +0200
Item accessed: May 28th, 2016 | 09:47:05 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500205727

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Scientific guideline: Draft Levodopa/Carbidopa/Entacapone film-coated tablet 200mg/50mg/200mg, 175mg/43.75mg/200mg, 150mg/37.5mg/200mg, 125mg/31.25mg/200mg, 100mg/25mg/200mg, 75mg/18.75mg/200mg and 50mg/12.5mg/200mg product-specific bioequivalence guidance, draft: consultation open
Item published on line: May 2nd, 2016 | 10:00:00 CEST +0200
Item accessed: May 28th, 2016 | 09:47:05 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500205728

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Scientific guideline: Draft Paliperidone prolonged-release tablet 1.5mg, 3mg, 6mg, 9mg and 12mg product-specific bioequivalence guidance, draft: consultation open
Item published on line: May 2nd, 2016 | 10:00:00 CEST +0200
Item accessed: May 28th, 2016 | 09:47:05 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500205729

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Scientific guideline: Draft Pazopanib film-coated tablet 200mg and 400mg product-specific bioequivalence guidance, draft: consultation open
Item published on line: May 2nd, 2016 | 10:00:00 CEST +0200
Item accessed: May 28th, 2016 | 09:47:05 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500205730

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Scientific guideline: Reflection paper providing an overview of the current regulatory testing requirements for veterinary medicinal products and opportunities for implementation of the 3Rs, draft: consultation open
Item published on line: April 29th, 2016 | 15:25:00 CEST +0200
Item accessed: May 28th, 2016 | 09:47:05 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500205609
In October 2014 the CHMP and CVMP agreed a draft guideline for consultation on regulatory acceptance of 3R (replacement, reduction, refinement) testing approaches (EMA/CHMP/CVMP/JEG- 3Rs/450091/2012).
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Scientific guideline: Reflection paper on anthelmintic resistance, draft: consultation open
Item published on line: April 29th, 2016 | 15:25:00 CEST +0200
Item accessed: May 28th, 2016 | 09:47:05 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500205608
Helminth infestations are common in most animals. Usually, there is a balance between helminth infestation and the immune system of the animal and thus helminths may not lead to clinical signs of disease.
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Scientific guideline: Concept paper on DNA vaccines non-amplifiable in eukaryotic cells for veterinary use, draft: consultation open
Item published on line: April 29th, 2016 | 15:25:00 CEST +0200
Item accessed: May 28th, 2016 | 09:47:05 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500205606
The ‘Note for guidance on DNA vaccines non-amplifiable in eukaryotic cells for veterinary use’ was adopted in March 2000 and came into effect on 1st January 2001.
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Scientific guideline: Concept paper for the revision of the CVMP guideline on the conduct of bioequivalence studies for veterinary medicinal products, draft: consultation open
Item published on line: April 29th, 2016 | 15:25:00 CEST +0200
Item accessed: May 28th, 2016 | 09:47:05 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500205605
The current CVMP guideline for the conduct of bioequivalence studies for veterinary medicinal products (EMA/CVMP/016/00-Rev.2) was first adopted in January 2001 and revised in April 2011.
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Regulatory and procedural guideline: Reflection paper on collecting and reporting information on off-label use in pharmacovigilance, draft: consultation open
Item published on line: April 29th, 2016 | 10:20:00 CEST +0200
Item accessed: May 28th, 2016 | 09:47:05 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500205499
This paper outlines a proposal for the collection and reporting of information on off-label use by Marketing Authorisation Holders (MAHs) in relation to their pharmacovigilance obligations provided in Title IX of Directive 2001/83/EC.
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TRUST Consultancy News Topic: European Medicines Agency (EMA)
Pending EC decisions and European Public Assessment Reports (EPARs): Human medicinal products

Pending EC decision: Sialanar, glycopyrronium bromide, Opinion date: 28-Apr-2016
Item published on line: May 27th, 2016 | 18:00:00 CEST +0200
Item accessed: May 28th, 2016 | 09:45:46 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003883/smops/Negative/human_smop_000976.jsp&mid=WC0b01ac058001d127

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Human medicines European public assessment report (EPAR): Procoralan, ivabradine, Revision: 16, Authorised
Item published on line: May 27th, 2016 | 16:00:00 CEST +0200
Item accessed: May 28th, 2016 | 09:45:46 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000597/human_med_000995.jsp&mid=WC0b01ac058001d124

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Human medicines European public assessment report (EPAR): Tepadina, thiotepa, Revision: 9, Authorised
Item published on line: May 27th, 2016 | 16:00:00 CEST +0200
Item accessed: May 28th, 2016 | 09:45:46 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001046/human_med_001229.jsp&mid=WC0b01ac058001d124

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Human medicines European public assessment report (EPAR): Myfenax, mycophenolate mofetil, Revision: 17, Authorised
Item published on line: May 27th, 2016 | 16:00:00 CEST +0200
Item accessed: May 28th, 2016 | 09:45:46 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000884/human_med_000914.jsp&mid=WC0b01ac058001d124

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Human medicines European public assessment report (EPAR): Evra, norelgestromin / ethinyl estradiol, Revision: 17, Authorised
Item published on line: May 27th, 2016 | 16:00:00 CEST +0200
Item accessed: May 28th, 2016 | 09:45:46 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000410/human_med_000775.jsp&mid=WC0b01ac058001d124

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Pending EC decision: Qtern, saxagliptin / dapagliflozin, Opinion date: 26-May-2016
Item published on line: May 27th, 2016 | 13:00:00 CEST +0200
Item accessed: May 28th, 2016 | 09:45:46 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004057/smops/Positive/human_smop_000988.jsp&mid=WC0b01ac058001d127

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Pending EC decision: Zepatier, elbasvir / grazoprevir, Opinion date: 26-May-2016
Item published on line: May 27th, 2016 | 13:00:00 CEST +0200
Item accessed: May 28th, 2016 | 09:45:46 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004126/smops/Positive/human_smop_000989.jsp&mid=WC0b01ac058001d127

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Pending EC decision: Epclusa, sofosbuvir / velpatasvir, Opinion date: 26-May-2016
Item published on line: May 27th, 2016 | 13:00:00 CEST +0200
Item accessed: May 28th, 2016 | 09:45:46 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004210/smops/Positive/human_smop_000990.jsp&mid=WC0b01ac058001d127

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Pending EC decision: Adcetris, brentuximab vedotin, Opinion date: 26-May-2016
Item published on line: May 27th, 2016 | 13:00:00 CEST +0200
Item accessed: May 28th, 2016 | 09:45:46 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002455/smops/Positive/human_smop_000982.jsp&mid=WC0b01ac058001d127

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Pending EC decision: Kyprolis, carfilzomib, Opinion date: 26-May-2016
Item published on line: May 27th, 2016 | 13:00:00 CEST +0200
Item accessed: May 28th, 2016 | 09:45:46 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003790/smops/Positive/human_smop_000984.jsp&mid=WC0b01ac058001d127

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Pending EC decision: Humira, adalimumab, Opinion date: 26-May-2016
Item published on line: May 27th, 2016 | 13:00:00 CEST +0200
Item accessed: May 28th, 2016 | 09:45:46 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000481/smops/Positive/human_smop_000983.jsp&mid=WC0b01ac058001d127

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Pending EC decision: Tysabri, natalizumab, Opinion date: 26-May-2016
Item published on line: May 27th, 2016 | 13:00:00 CEST +0200
Item accessed: May 28th, 2016 | 09:45:46 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000603/smops/Positive/human_smop_000987.jsp&mid=WC0b01ac058001d127

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Human medicines European public assessment report (EPAR): Idelvion, albutrepenonacog alfa, Revision: 0, Authorised
Item published on line: May 27th, 2016 | 13:00:00 CEST +0200
Item accessed: May 28th, 2016 | 09:45:46 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003955/human_med_001974.jsp&mid=WC0b01ac058001d124

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Pending EC decision: Ninlaro, ixazomib, Opinion date: 26-May-2016
Item published on line: May 27th, 2016 | 13:00:00 CEST +0200
Item accessed: May 28th, 2016 | 09:45:46 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003844/smops/Negative/human_smop_000991.jsp&mid=WC0b01ac058001d127

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Pending EC decision: Pemetrexed Fresenius Kabi, pemetrexed, Opinion date: 26-May-2016
Item published on line: May 27th, 2016 | 13:00:00 CEST +0200
Item accessed: May 28th, 2016 | 09:45:46 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003895/smops/Positive/human_smop_000979.jsp&mid=WC0b01ac058001d127

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Pending EC decision: Bortezomib Sun, bortezomib, Opinion date: 26-May-2016
Item published on line: May 27th, 2016 | 13:00:00 CEST +0200
Item accessed: May 28th, 2016 | 09:45:46 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004076/smops/Positive/human_smop_000980.jsp&mid=WC0b01ac058001d127

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Pending EC decision: Bortezomib Hospira, bortezomib, Opinion date: 26-May-2016
Item published on line: May 27th, 2016 | 13:00:00 CEST +0200
Item accessed: May 28th, 2016 | 09:45:46 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004207/smops/Positive/human_smop_000981.jsp&mid=WC0b01ac058001d127

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Pending EC decision: Revestive, teduglutide, Opinion date: 26-May-2016
Item published on line: May 27th, 2016 | 13:00:00 CEST +0200
Item accessed: May 28th, 2016 | 09:45:46 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002345/smops/Positive/human_smop_000985.jsp&mid=WC0b01ac058001d127

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Pending EC decision: Simponi, golimumab, Opinion date: 26-May-2016
Item published on line: May 27th, 2016 | 13:00:00 CEST +0200
Item accessed: May 28th, 2016 | 09:45:46 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000992/smops/Positive/human_smop_000986.jsp&mid=WC0b01ac058001d127

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Human medicines European public assessment report (EPAR): Zydelig, idelalisib, Revision: 5, Authorised
Item published on line: May 27th, 2016 | 12:30:00 CEST +0200
Item accessed: May 28th, 2016 | 09:45:46 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003843/human_med_001803.jsp&mid=WC0b01ac058001d124

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Human medicines European public assessment report (EPAR): Imvanex, modified vaccinia Ankara virus, Revision: 7, Authorised
Item published on line: May 27th, 2016 | 12:05:00 CEST +0200
Item accessed: May 28th, 2016 | 09:45:46 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): Darzalex, daratumumab, Revision: 0, Authorised
Item published on line: May 27th, 2016 | 11:40:00 CEST +0200
Item accessed: May 28th, 2016 | 09:45:46 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004077/human_med_001979.jsp&mid=WC0b01ac058001d124

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Human medicines European public assessment report (EPAR): Benlysta, belimumab, Revision: 12, Authorised
Item published on line: May 27th, 2016 | 10:15:00 CEST +0200
Item accessed: May 28th, 2016 | 09:45:46 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): Zerbaxa, ceftolozane / tazobactam, Revision: 3, Authorised
Item published on line: May 27th, 2016 | 10:15:00 CEST +0200
Item accessed: May 28th, 2016 | 09:45:46 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003772/human_med_001917.jsp&mid=WC0b01ac058001d124

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Human medicines European public assessment report (EPAR): Orkambi, lumacaftor / ivacaftor, Revision: 2, Authorised
Item published on line: May 27th, 2016 | 10:15:00 CEST +0200
Item accessed: May 28th, 2016 | 09:45:46 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003954/human_med_001935.jsp&mid=WC0b01ac058001d124

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