Tag Archives: EMA

EMA and the European Commission update guidance to prepare pharmaceutical companies for UK’s withdrawal from the EU

Publication of updated Q+As and practical guidance LONDON, 20-Jun-2018 — /EuropaWire/ — The European Medicines Agency (EMA) and the European Commission have updated their guidance to help pharmaceutical companies prepare for the United Kingdom’s (UK) withdrawal from the European Union (EU). Updates to the questions-and-answers … Read the full press release

EMA, PMDA and the FDA host a workshop to discuss the development of antibiotics for children, London on 21-22 June 2018

Workshop with regulators from EU, Japan and US open for registration LONDON, 28-May-2018 — /EuropaWire/ — The European Medicines Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and the United States’ Food and Drug Administration (FDA) are co-organising a workshop to discuss the development … Read the full press release

Sandoz: EMA Committee for Medicinal Products for Human Use (CHMP) adopts positive opinion for marketing authorization of infliximab

Sandoz is seeking approval of biosimilar infliximab for use in all indications of its reference medicine across gastroenterology, rheumatology and dermatology Positive opinion is based on comprehensive clinical and non-clinical data that is expected to confirm that Sandoz biosimilar infliximab … Read the full press release

EU Member States to select new host city for the European Medicines Agency (EMA) on 20 November 2017

Close collaboration with new host country as of day one key for successful move LONDON, 09-Nov-2017 — /EuropaWire/ — With less than two weeks to go before EU Member States select a new host city for the European Medicines Agency (EMA) … Read the full press release

European Medicines Agency (EMA): Updated annex to excipient guidelines has new safety advice for 15 excipients

LONDON, 10-Oct-2017 — /EuropaWire/ — The European Medicines Agency (EMA) and the European Commission have updated the annex to the European Commission guideline on excipients in the labelling and package leaflet of medicinal products for human use. Excipients refer to everything in a medicine other than the active substance. While most excipients are considered inactive, some can have … Read the full press release

European Medicines Agency (EMA), EU healthcare payers discussed how their cooperation can contribute to boosting sustainable access to medicines for EU citizens

European Medicines Agency and healthcare payer organisations held joint meeting on 19 September LONDON, 29-Sep-2017 — /EuropaWire/ — The European Medicines Agency (EMA) and European Union (EU) healthcare payers met for the first time on 19 September 2017 at EMA’s offices … Read the full press release

New hosts for UK-based EU agencies EMA and EBA will now be assessed by the European Commission

BRUSSELS, 03-Aug-2017 — /EuropaWire/ — The application procedure to host the two UK-based EU agencies, the European Medicines Agency (EMA) and the European Banking Authority (EBA), came to a close at midnight last night, 31 July 2017. The European Commission will … 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

European Medicines Agency develops framework and action plan for closer interaction with academic community

LONDON, 03-Apr-2017 — /EuropaWire/ — As a science-driven organisation, the European Medicines Agency (EMA) has developed a framework to formalise, structure and further develop interactions with the academic community in the context of the European medicines regulatory network. The framework … Read the full press release

EMA to broadcast workshops on personalised medicines

EMA workshop will discuss role of patients, consumers and healthcare professionals LONDON, 07-Mar-2017 — /EuropaWire/ — How has the concept of personalised medicine evolved globally and in the European Union and what are its regulatory challenges and opportunities? These are some … Read the full press release

Roche’s Marketing Authorisation Application and Biologics License Application for OCREVUS accepted by EMA and FDA

OCREVUS is the first investigational medicine seeking marketing authorisation for both relapsing and primary progressive multiple sclerosis (MS) FDA grants Priority Review Designation for OCREVUS Biologics License Application (BLA) BASEL, 29-Jun-2016 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced … 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

EMA: Call for civil society members to join two EMA committees extended until 18 October

Deadline to submit expressions of interest to represent civil society at PRAC andCAT to European Commission extended until 18 October LONDON, 1-10-2015 — /EuropaWire/ — The Health and Food Safety Directorate-General of the European Commission has extended the deadline for … 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

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

GSK submits variation to the Marketing Authorisation for eltrombopag (Revolade™) to the European Medicines Agency (EMA)

LONDON, 13-11-2014 — /EuropaWire/ — GSK today announced the submission to the European Medicines Agency (EMA) of a variation to the Marketing Authorisation for eltrombopag (Revolade™), seeking an additional indication for the treatment of adult patients with severe aplastic anaemia … Read the full press release

EMA and US FDA published joint first conclusions of parallel assessment of quality-by-design applications (QbD)

29-8-2013 — /EuropaWire/ — The European Medicines Agency (EMA) and the United States Food and Drug Administration (US FDA) have published a joint question-and-answer document that outlines the conclusions of their first parallel assessment of quality-by-design (QbD) elements of marketing-authorisation applications. Quality-by-design is a science- and … 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

European Medicines Agency: Concerns have been raised in the media about certain stem cell therapy treatments

23-4-2013 — /europawire.eu/ — These sorts of new techniques potentially offer exciting possibilities to patients for the treatment of a range of difficult or previously untreatable conditions. Like all treatments, these techniques also come with benefits and risks. Specific rules were introduced … Read the full press release