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| TOPICAL NEWS AND PUBLICATIONS |
| European Medicines Agency holds first scientific workshop on nanomedicines | Sep. 07, 2010 |
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European and international experts prepare for the evaluation of future nanomedicines... |
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| European Medicines Agency starts review of Pandemrix | Aug. 31, 2010 |
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Agency is investigating whether there is a link between vaccine and cases of narcolepsy The European Medicines Agency has launched a review of Pandemrix on the request of the European Commission to investigate whether there is a link between cases of narcolepsy and vaccination with Pandemrix. A limited number of cases was reported, all collected through spontaneous reporting systems, mainly in Sweden and Finland. Pandemrix, an influenza vaccine, has been used since September 2009 for vaccination against H1N1 influenza... |
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| Agency website down for maintenance from 18:00 UK time 27 August until 09:00 UK time 30 August | Aug. 27, 2010 |
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The European Medicines Agency website at http://www.ema.europa.eu will be down for essential maintenance from 1800 UK time on Friday 27 August until Monday 30 August 0900 UK time. In addition, the following websites and applications will be down during... |
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| News from the EMA / Activities of the PDCO / August meeting | Aug. 18, 2010 |
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| During its meeting from 4–6 August 2010 the Paediatric Committee (PDCO) adopted the following opinions... | ||||||
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| EMA and US FDA seek potential candidate companies for joint GMP inspection programme | Aug. 13, 2010 |
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The European Medicines Agency (EMA) and the Food and Drug Administration of the United States of America (US FDA) continue to seek potential candidate companies for a joint GMP inspection pilot programme for manufacturers of medicinal products. Companies that have submitted in parallel two equivalent marketing authorisation applications for the same... |
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| News from the EMEA / Activities of the PDCO / July meeting | Aug. 09, 2010 |
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| During its meeting from 14–16 July 2010 the Paediatric Committee (PDCO) adopted the following opinions... | ||||||
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| News from the EMA / Activities of the CHMP / July meeting | Aug. 09, 2010 |
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| During its meeting from 19 - 22 July 2010 the Committee for Human Medicinal Products (CHMP) adopted... | ||||||
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| Reminder to applicants regarding requirements for all future eCTD submissions | Jul. 20, 2010 |
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Applicants are advised that from 1 July 2010 the EU M1 v1.4 must be used for all eCTD submissions for all European procedures, and any eCTD submissions provided from this date using any previous version of the EU M1 specification (v1.0. v1.1, v1.2.1 or v1.3) will not be accepted... |
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| Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 13-15 July 2010 | Jul. 19, 2010 |
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The Committee adopted by consensus a positive opinion for an initial marketing authorisation application under exceptional circumstances in accordance with Article 32 of Regulation (EC) No 726/2004 for... |
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| European Medicines Agency launches new website | Jul. 19, 2010 |
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The European Medicines Agency today unveiled its new corporate website at www.ema.europa.eu. The site has been completely redesigned and rebuilt to optimize usability for the Agencys key online audiences and build on existing activities to improve openness and transparency. |
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| European Medicines Agency starts review of rosiglitazone-containing medicines | Jul. 12, 2010 |
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The European Medicines Agency has started a review of the rosiglitazone-containing anti-diabetes medicines Avandia, Avandamet and Avaglim, to determine whether new data on the risk of cardiovascular problems have an impact on their... Read more: http://www.ema.europa.eu/humandocs/PDFs/EPAR/Avandia/42516610en.pdf |
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| Vacancy notice for the European Medicines Agency Executive Director | Jul. 08, 2010 |
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| The vacancy notice for the Executive Director will be soon republished in the media as the conditions and requirements are being reviewed. Despite attempts to cancel the previous publication, a number of advertisements have appeared in some national media in recent days. The European Commission will publish a new vacancy notice shortly in the Official Journal of the European Union, which will also be advertised in national media and selected journals. Candidates who responded to these advertisements will be informed by the Commission services as soon as the republication date is known. | |||||
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| European Medicines Agency and European Commission start reflection process on way forward for the Agency and the network | Jul. 08, 2010 |
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The European Medicines Agency and the European Commission held a joint one-day conference on 30 June 2010 to discuss the outcome of the recent evaluation of the Agency and how the findings of the exercise can be used in preparing the Agency... Read more: http://www.ema.europa.eu/pdfs/general/direct/pr/42253510en.pdf |
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| European Medicines Agency updates treatment recommendations because of continued Fabrazyme shortage | Jul. 06, 2010 |
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The European Medicines Agencys Committee for Medicinal Products for Human Use (CHMP) has been obliged to revise its previous recommendations on the use of Fabrazyme (agalsidase beta). This follows information from the manufacturer, Genzyme, stating that the current supply... Read more: http://www.ema.europa.eu/pdfs/general/direct/pr/42827710en.pdf |
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| CHMP re-elects its Chair and Vice-Chair | Jul. 05, 2010 |
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The Agencys Committee for Medicinal Products for Human Use (CHMP) unanimously re-elected Dr Eric Abadie as its Chair and Dr Tomas Salmonson as its Vice-Chair for a second 3-year mandate, during the June 2010 CHMP meeting. Monthly report of the June 2010 CHMP meeting: http://www.ema.europa.eu/pdfs/human/press/pr/41043110en.pdf |
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| SME Office wins award for "Most significant contribution to mediscience sector" | Jun. 28, 2010 |
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The European Medicines Agency is honoured that the work of its SME Office has been recognised at the European Mediscience Awards Dinner 2010 – the largest annual gathering of quoted healthcare, biotech and life-sciences companies in Europe. Established in 2005, the Agencys SME Office provides financial incentives and administrative assistance specifically to smaller European companies developing innovative new medicines. |
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| Call for expression of interest for health professional and patient organisations representatives for the Paediatric Committee (PDCO) launched | Jun. 28, 2010 |
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The European Commission is looking for three representatives from patient organisations and three representatives from healthcare professional organisations to join the PDCO as full members for a new three-year mandate. This call is intended to replace the members who were appointed for the period starting on 1 August 2008. Current members may reapply. The Committee meets for three consecutive days each month in London. Representatives from civil society are involved in the PDCO’s procedures in the same way as all other members and should be prepared to actively contribute to the PDCO’s scientific discussions about medicines for children. Full description of the position and applying instructions: http://ec.europa.eu/health/files/paediatrics/call_2010_06.pdf |
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| News from the EMA / Activities of the CHMP / June meeting | Jun. 28, 2010 |
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| During its meeting from 21 - 24 June 2010 the Committee for Human Medicinal Products (CHMP) adopted... | ||||||
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| Public statement on Duloxetine Boeringer Ingelheim (duloxetine): Withdrawal of the marketing authorisation in the European Union | Jun. 22, 2010 |
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On the 8th October 2008 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Duloxetine Boehringer Ingelheim, duloxetine, which had been approved for the treatment of diabetic peripheral... Read more: http://www.ema.europa.eu/humandocs/PDFs/EPAR/duloxetineboehringeringelheim/16805710en.pdf |
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| Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 15-17 June 2010 | Jun. 21, 2010 |
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The Committee elected Dr Anja Holm from Denmark as its Chair for a 3-year mandate. The Committee also re-elected Dr Rory Breathnach as the Chair of the Scientific Advice Working Party for a further 3-year mandate... Read more: http://www.ema.europa.eu/pdfs/vet/press/pr/35456510en.pdf |
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| European Medicines Agency Management Board re-elects Pat O Mahony as chair | Jun. 21, 2010 |
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At its 10 June 2010 meeting in London, the European Medicines Agencys Management Board unanimously re-elected Pat O Mahony, Chief Executive of the Irish Medicines Board, as chair for a second three-year mandate... Read more: http://www.ema.europa.eu/pdfs/general/manage/mbpr/37610310en.pdf |
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| News from the EMEA / Activities of the PDCO / June meeting | Jun. 21, 2010 |
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| During its meeting from 9-11 June 2010 the Paediatric Committee (PDCO) adopted the following opinions... | ||||||
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| European Medicines Agency and European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) sign cooperation agreement | Jun. 14, 2010 |
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The new arrangement between the two agencies furthers cooperation and boosts exchange of information and expertise on psychoactive substances. The EMCDDA will report on an ad hoc basis to the EMA on any misuse of medicinal products detected through its networks, complementing information gathered through the EU pharmacovigilance system. The EMA will be able to provide ad hoc reports to the EMCDDA on the misuse of authorised medicinal products. More information about the agreement is available here: http://www.ema.europa.eu/pdfs/general/direct/24891610en.pdf |
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| European Medicines Agency and European Network of Centres for Pharmacoepidemiology & Pharmacovigilance (ENCePP) launch "ENCePP studies" | Jun. 14, 2010 |
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On 8 June 2010 the European Medicines Agency and the European Network of Centres for Pharmacoepidemiology & Pharmacovigilance (ENCePP) launched "ENCePP studies". Building on the foundations of the ENCePP network of Excellence, "ENCePP studies" is a seal for EU-based, benefit/risk or risk studies that are carried out in... Read more: http://www.ema.europa.eu/pdfs/general/direct/pr/34360510en.pdf |
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| News from the EMA / Activities of the COMP / June meeting | Jun. 09, 2010 |
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| The COMP met on 1-3 June 2010 and adopted the following 20 positive opinions on orphan medicinal product designation... | ||||||
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| Nineteenth pandemic pharmacovigilance update | Jun. 09, 2010 |
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This report summarises the adverse drug reactions reported after the use of the centrally authorised pandemic vaccines Arepanrix, Celvapan, Focetria and Pandemrix, and the antiviral Tamiflu1. It also provides information on the evolution of the H1N1 pandemic, an estimate... Read more: http://www.ema.europa.eu/pdfs/influenza/35608710en.pdf |
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| EMA and EU Commission – Topical News / Handling of Duplicate Marketing Authorisation Applications in the Centralised Procedure (ENTR/F/RSR 38016) / pharmind® 05-2010 | Jun. 02, 2010 |
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| On 30 March 2010, the European Commission published a note on the handling of duplicate marketing authorisation applications in the centralised procedure. The note aims at the creation of more transparency and predictability regarding the criteria which have to be complied with in order to obtain a Commission authorisation to submit a duplicate marketing authorisation... | ||||||
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| European Medicines Agency launches public consultation on ethical and good clinical practice (GCP) aspects of clinical trials conducted in third countries | Jun. 02, 2010 |
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The European Medicines Agency is inviting public comments on its ’Reflection paper on ethical and GCP aspects of clinical trials conducted in third countries for evaluation in marketing authorisation applications for medicines for human use, submitted to the EMA’. Draft reflection paper: http://www.ema.europa.eu/Inspections/docs/71239709en.pdf |
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| Wyeth Europa Limited withdraws its marketing authorisation application for Brilence | Jun. 02, 2010 |
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The European Medicines Agency has been formally notified by Wyeth Europa Limited of its decision to withdraw its duplicate application for a centralised marketing authorisation for the medicine Brilence (bazedoxifene), 20 mg film-coated tablets... Read more: http://www.ema.europa.eu/humandocs/PDFs/EPAR/brilence/34227310en.pdf |
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