- News and Events
This section of the website contains the European Medicines Agency's news and press releases, information on meetings and events, public consultations and related information.
For a scrolling feed of all of the new and updated information published on the website, see the what's new page.
Regulatory information – new formatted table template to be used in selected veterinary procedural submission cover letters
The European Medicines Agency has published a new formatted table template that all companies need to insert in the cover letters of selected applications for veterinary medicines from now on. ... Read more
Fourteen new veterinary medicines were recommended for marketing authorisation by the European Medicines Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) in the first half of 2014. ... Read more
Guide on methodological standards in pharmacoepidemiology revised to include pharmacogenetic studies
The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), coordinated by the European Medicines Agency, has revised its guide on methodological standards in pharmacoepidemiology to include a chapter on the design and analysis of pharmacogenetic studies. ... Read more
The Committee adopted by consensus a positive opinion for an initial marketing authorisation application for Nobilis IB Primo QX (lyophilisate and solvent for suspension), from Intervet International B.V., a vaccine for the active immunisation of chickens from one day-old onwards in order to reduce respiratory signs of infectious bronchitis. ... Read more
The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) concluded two safety reviews and gave a recommendation as part of a regular benefit-risk assessment review of a medicine at its July meeting. ... Read more
European Medicines Agency recommends 39 medicines for human use for marketing authorisation in first half of 2014
Thirty-nine medicines for human use were recommended for marketing authorisation by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in the first half of 2014, compared with 44 in first half of 2013 and 33 in first half of 2012. ... Read more
Registration opens for workshop on clinical trial design in neuromyelitis optica to facilitate global medicine development in a rare and serious disease
Registration is now open for a regulatory workshop on clinical trial design in neuromyelitis optica and spectrum disorders at the European Medicines Agency on 10 October 2014. ... Read more
Management Board delays formal adoption of EMA publication of clinical trial data policy to October 2014
The Management Board of the European Medicines Agency (EMA) has postponed formal adoption of the policy on publication of clinical trial data to its 2 October 2014 meeting. ... Read more
European Medicines Agency releases revised guidance on advanced-therapy classification for public consultation
The European Medicines Agency’s Committee for Advanced Therapies (CAT) has revised a reflection paper on the classification of advanced-therapy medicinal products (ATMPs) to reflect the current thinking of the committee on how ATMPs should be classified. ... Read more
This page provides an overview of the opinions adopted at the June 2014 meeting of the Committee for Medicinal Products for Human Use (CHMP) and other important outcomes. ... Read more
This month's events
13/09/2012 - 14/09/2012 : CAT
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.
11/09/2012 - 13/09/2012 : CVMP
The Committee for Medicinal Products for Veterinary Use (CVMP) is the committee that is responsible for preparing the Agency's opinions on all questions concerning veterinary 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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