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If you want to find news, press releases, public statements and information on meetings and events then this section of the website contains all you need. You can also review the What's New page which is a scrolling feed of all new information published on the website daily.
Latest News
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18/06/2013
European Medicines Agency revises MUMS / limited-market policy
The European Medicines Agency has published a public statement revising the operation of the minor-use-minor-species (MUMS) / limited-market policy for veterinary medicines. ... Read more
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17/06/2013
European Medicines Agency’s Management Board endorses revised EMA Code of Conduct
At its meeting held on 13 June 2013, the European Medicines Agency’s (EMA) Management Board adopted the revised EMA Code of Conduct, which aims to ensure that the Agency maintains the highest professional standards of integrity, transparency and independence. ... Read more
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14/06/2013
Registration opens for workshop on EMA-HTA parallel scientific advice in drug development
The European Medicines Agency (EMA) is inviting expressions of interest in attending its workshop on parallel scientific advice in drug development with health-technology-assessment (HTA) bodies on 26 November 2013. ... Read more
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14/06/2013
Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 11-13 June 2013
The Committee adopted by consensus a positive opinion for an extension of the existing authorisation for Econor (valnemulin) from Novartis Animal Health GmbH concerning the addition of a new target species, rabbits for reduction of mortality during an outbreak of epizootic rabbit enteropathy. ... Read more
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14/06/2013
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 June 2013
The Pharmacovigilance Risk Assessment Committee (PRAC) made recommendations on four safety referrals at its June 2013 meeting. ... Read more
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14/06/2013
PRAC recommends restricting the use of flupirtine-containing medicines
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has concluded its review of flupirtine-containing medicines and recommended restrictions in their use. ... Read more
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14/06/2013
PRAC recommends restricting the use of codeine when used for pain relief in children
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended a series of measures to address safety concerns with codeine-containing medicines when used for the management of pain in children. ... Read more
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14/06/2013
PRAC recommends suspending marketing authorisations for infusion solutions containing hydroxyethyl-starch
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has concluded following a review of the available evidence that the benefits of infusion solutions containing hydroxyethyl-starch (HES) no longer outweigh their risks and therefore recommended that the marketing authorisations for these medicines be suspended. ... Read more
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14/06/2013
PRAC recommends the same cardiovascular precautions for diclofenac as for selective COX-2 inhibitors
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that the effects of the painkiller diclofenac on the heart and circulation when given systemically (by means such as capsules, tablets or injections) are similar to those of selective COX-2 inhibitors, another group of painkillers. ... Read more
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10/06/2013
Revised guideline on biosimilars containing biotechnology-derived proteins published for public consultation
The European Medicines Agency has released a revision of the guideline addressing the clinical and non-clinical issues related to similar biological products (biosimilars) containing biotechnology-derived proteins as the active substance for a six-month public consultation. ... Read more
Latest Events
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08/03/2012 - 09/03/2012 :
2012 European Medicines Agency/International Federation for Animal Health Europe info day
The European Medicines Agency/International Federation for Animal Health Europe info day 2012 covers the latest developments in the scientific review, legislation and marketing authorisation procedure. It is an opportunity for professionals to get first-hand information on current developments in the regulatory scene. Registration open until 24 February 2012, places limited.
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08/03/2012 - 09/03/2012 : CAT
Committee for Advanced Therapies (CAT): 8-9 March 2012
The Committee for Advanced Therapies (CAT) is the committee that is responsible for assessing the quality, safety and efficacy of advanced-therapy medicines. It does not currently publish the minutes or agendas of its meetings. It does publish a meeting report after each meeting.
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07/03/2012 - 09/03/2012 : PDCO
Paediatric Committee (PDCO): 7-9 March 2012
The Paediatric Committee (PDCO) is the committee that is responsible for assessing the content of paediatric investigation plans, which describe how a medicine should be studied in children, as well as waivers and deferrals. It does not currently publish the minutes or agendas of its meetings. It does publish a meeting report after each meeting.
Latest Human Alerts
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17/12/2012
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19/11/2012
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23/10/2012
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19/10/2012
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24/08/2012
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20/07/2012
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22/06/2012
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22/06/2012
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22/06/2012
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25/05/2012