European News Updates

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These European updates are some of the recent key regulatory news items we have noted, including those from the regulatory agencies and authorities in Europe. A two-letter code is used at the beginning of each item to indicate the country or region, according to the ISO list.

[UK] MHRA: Information sent to healthcare professionals in August about the safety of medicines

A list of letters sent to healthcare professionals in August 2010, to inform of new safety information and advice.

[EU] EMA: News and Press Releases CHMP meeting on 8 September 2010 to discuss Avandia and Pandemrix

The Committee for Medicinal Products for Human Use (CHMP) is meeting on Wednesday 8 September to discuss the ongoing benefit-risk review of the rosiglitazone-containing medicines Avandia, Avandamet and Avaglim.

[DK] Danish Medicines Agency: Danish Pharmacovigilance Update

The newsletter Danish Pharmacovigilance Update puts focus on medicine and its side effects. The purpose of Danish Pharmacovigilance Update is to give primarily doctors quick and easy access to the most important information about medicine and side effects.

[NL] MEB: Suspension of medicinal products containing cyclosporine

Based on a decision by the European Commission the Medicines Evaluation Board has suspended the marketing authorisation of six medicinal products containing cyclosporine with immediate effect. Subsequent to assessment of a new bioequivalence study the suspension of the marketing authorisation may be lifted.

[DK] Danish Medicines Agency: EudraCT portal available 2 - 7 September 2010

We have previously stated that the EudraCT portal would be unavailable 2 - 7 September 2010. However, the planned deployment of EudraCT Version 8 is delayed, and the portal will remain available in the period mentioned.

[NL] MEB: Publication on investigation into the implementation of pregnancy prevention programmes for isotretinoin in Europe

The implementation process for the pregnancy prevention programme (ZPP) for isotretinoin in Europe is still lacking. This became clear from a literature review analysing studies that have been carried out. Therefore treatment with isotretinoin must be researched in even greater detail for the pregnancy prevention programme to see whether any measures should be taken, bearing the eventual aim and disadvantages of use in mind.

[NL] MEB: 20 August 2010 – Monthly update: state of affairs concerning backlogs

The backlogs in implementation of European procedures slightly decreased in the past month, while the backlogs in national procedures increased somewhat.

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The European Medicines Agency on Twitter

The European Medicines Agency have created a news feed on Twitter (https://twitter.com/EMA_News). However, some companies have chosen to block access to Twitter for employees. To help regulatory professionals in those companies, we render recent items from their news feed on our site, for accessibility.