Tag Archives: The European Medicines Agency

The European Medicines Agency launches new online portal for orphan designation applications

EMA launches new submission portal today LONDON, 20-Jun-2018 — /EuropaWire/ — The European Medicines Agency (EMA) has launched a new secure online portal for orphan designation applications. The portal, named ‘Iris’, provides a single space where applicants can submit and manage the information and … Read the full press release

Sweden submitted its official offer to host the The European Medicines Agency (EMA)

The European Medicines Agency (EMA) is currently looking for a new location in connection with the UK’s withdrawal from the EU. Sweden has now submitted its official offer to host the EMA. STOCKHOLM, 03-Aug-2017 — /EuropaWire/ — The offer guarantees … Read the full press release

The European Medicines Agency publishes guidance for the publication of clinical data

Requirements for industry now available on submission of clinical data for publication LONDON, 04-Mar-2016 — /EuropaWire/ — The European Medicines Agency (EMA) has published detailed guidance for pharmaceutical companies on the requirements to comply with its policy on the publication of … Read the full press release

The European Medicines Agency (EMA) veterinary committee sets objectives to limit risks arising from use of antimicrobials in animals

EMA veterinary committee sets objectives to limit risks arising from use of antimicrobials in animals LONDON, 20-11-2015 — /EuropaWire/ — The European Medicines Agency has released for public consultation a new strategy on antimicrobials for 2016-2020 adopted by its Committee … Read the full press release

The European Medicines Agency starts review of HPV vaccines to further clarify aspects of their safety profile

LONDON, 14-7-2015 — /EuropaWire/ — The European Medicines Agency (EMA) has started a review of HPV vaccines to further clarify aspects of their safety profile. These vaccines have been used in around 72 million people worldwide and their use is … Read the full press release

The European Medicines Agency publishes workshop report on how to ensure the availability of veterinary vaccines in the European Union

EMA publishes workshop report on requirements for the authorisation of vaccines LONDON, 14-7-2015 — /EuropaWire/ — The European Medicines Agency (EMA) has published today the outcome of a workshop which explored how to ensure the availability of veterinary vaccines in … Read the full press release

The European Medicines Agency releases draft guideline on the development of gene therapies

EMA invites feedback on its new draft guideline LONDON, 22-5-2015 — /EuropaWire/ — The European Medicines Agency (EMA) has released a draft guideline on quality, non-clinical and clinical aspects of gene therapies for a three-month public consultation. The document aims … Read the full press release

The European Medicines Agency to host workshop on the use of bacteriophages to treat bacterial infections on 8 June 2015

EMA to host workshop on therapeutic use of bacteriophages LONDON, 22-5-2015 — /EuropaWire/ — The European Medicines Agency (EMA) will host a workshop on the use of bacteriophages to treat bacterial infections on 8 June 2015. The workshop will be … Read the full press release

European Network of Paediatric Research at the European Medicines Agency will hold its 7th annual workshop on 28 May 2015 at the EMA

Registration now open for a workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) on 28 May 2015 LONDON, 9-4-2015 — /EuropaWire/ — Enpr-EMA will hold its 7th annual workshop on 28 May 2015 at … Read the full press release

The European Medicines Agency gives scientific advice to GSK on its development plan for an Ebola vaccine

Developers encouraged to request accelerated procedure for scientific advice LONDON, 30-10-2014 — /EuropaWire/ — The European Medicines Agency (EMA) has given scientific advice to GSK on its development plan for an Ebola vaccine. This is the first time in the … Read the full press release

The European Medicines Agency to publish full details of its adjusted fees at the end of March

LONDON, 4-3-2014 — /EuropaWire/ — The European Medicines Agency reminds applicants and marketing-authorisation holders that adjusted fees will be coming into effect on Tuesday 1 April 2014. Every year, the Agency adjusts its fees on 1 April, in line with the European … Read the full press release

The European Medicines Agency published ‘First annual report on EudraVigilance for the European Parliament, the Council and the Commission’ 1 January – 31 December 2012

30-7-2013 — /EuropaWire/ — The European Medicines Agency (EMA) has published the ‘First annual report onEudraVigilance for the European Parliament, the Council and the Commission’, which covers the period from 1 January to 31 December 2012. It is the third time the … Read the full press release

The European Medicines Agency’s new database EudraGMDP will now contain GDP & GMP information

Key deliverable of Falsified Medicines Directive achieved 22-4-2013 — /europawire.eu/ — The European Medicines Agency has upgraded its EudraGMP database so that it now contains information on good distribution practice (GDP) in addition to good manufacturing practice (GMP). The new database, now called EudraGMDP, is a … Read the full press release