Tag Archives: European Medicines Agency

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

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

European Medicines Agency accepted Sandoz’s Marketing Authorization Application for biosimilar to Roche’s EU-licensed MabThera®

Sandoz advances biosimilar portfolio with sixth major biosimilar file acceptance in less than one year Sandoz is seeking approval for all indications included in the reference product’s label Sandoz’ submission includes data from multiple clinical trials with over 800 patients … Read the full press release

AstraZeneca announces positive CHMP opinion recommending the approval of new antibiotic, CAZ AVI

LONDON, 02-May-2016 — /EuropaWire/ — AstraZeneca today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending the approval of a new antibiotic, CAZ AVI 2g/0.5g powder. CAZ … Read the full press release

European Medicines Agency extends deadline for submitting expressions of interest to participate in the information-sharing initiative for generics

Companies encouraged to submit expressions of interest LONDON, 23-4-2015 — /EuropaWire/ — The deadline for submitting expressions of interest to participate in the information-sharing initiative for generics has been extended to give more time to companies to submit their applications. … 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

European Medicines Agency publishes its revised overarching guideline on biosimilars; possibility for medicines developers to use non-EEA authorised comparator in clinical studies

EMA to allow use of non-EEA authorised comparator in clinical studies; new guidance applicable as of today LONDON, 30-10-2014 — /EuropaWire/ — The European Medicines Agency (EMA) has published its revised overarching guideline on biosimilars. The main change brought by this … 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

EMA’s view on coated nanomedicines general issues published

16-8-2013 — /EuropaWire/ — The European Medicines Agency has published a reflection paper on general issues for consideration regarding the parenteral administration of coated nanomedicines today. The reflection paper describes general issues to consider during the development of nanomedicines that have a coating, including: the effect … Read the full press release

EMA training sessions on eSubmission Gateway and web client for PSUR single-assessment submissions

12-7-2013 — /europawire.eu/ — The European Medicines Agency is organising training sessions on the use of the eSubmission Gateway and web client to submit periodic safety update reports (PSURs) subject to the single-assessment procedure. These training sessions are intended for all applicants submitting … Read the full press release

The European Medicines Agency released its draft policy on the publication and access to clinical-trial data for 3-month public consultation

26-6-2013 — /europawire.eu/ — The European Medicines Agency has released a draft policy on the publication and access to clinical-trial data for a three-month public consultation. Stakeholders have until 30 September 2013 to send their comments on the draft policy to … 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

European Medicines Agency recommends approval of first higher-strength insulin for treatment of patients with diabetes mellitus in the EU

London, 23-10-2012 — /europawire.eu/ — The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has made a recommendation to give marketing authorisation to insulin degludec, a new basal analogue insulin for the treatment of diabetes mellitus in adults. It … Read the full press release