Following a successful pilot, the European Medicines Agency’s eSubmission Gateway is now live for all applications for centralised marketing authorisations for human medicines.
Go to Source

The European Medicines Agency is inviting comments on the recently published ICH E2C (R2) guideline on periodic benefit-risk evaluation report from its stakeholders.
Go to Source

The European Medicines Agency today published the final reflection paper on ethical and good clinical practice (GCP) aspects of clinical trials of medicinal products for human use conducted outside of the European Union (EU)/European Economic Area (EEA) and submitted in marketing authorisation applications to the EU regulatory authorities.
Go to Source

Dr Agnès Saint Raymond, the European Medicines Agency’s Head of Human Medicines Special Areas has been asked to become a member of the United Nations Commission on Life-Saving Commodities for Women and Children.
Go to Source

The European Medicines Agency has published a new document on regulatory procedural advice for similar biological medicines.
Go to Source

The European Medicines Agency supports World Veterinary Day, taking place on Saturday 28 April 2012.
Go to Source

The European Medicines Agency has published a set of updated versions of Extended EudraVigilance product report message (XEVMPD) controlled vocabularies.
Go to Source

The European Medicines Agency released a reflection paper on the classification of advanced-therapy medicines for public consultation today.
Go to Source

The European Medicines Agency is closed from 6.30pm on Monday 30 April until 7.30am on Wednesday 2 May 2012.
Go to Source

The European Medicines Agency has formally launched its new Scientific Coordination Board.
Go to Source

The Committee adopted, by consensus, positive opinions for initial marketing authorisation applications for the following medicinal products.
Go to Source

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) at its April 2012 meeting maintained its recommendation not to grant a marketing authorisation for the orphan medicine Glybera (alipogene tiparvovec), from Amsterdam Molecular Therapeutics B.V.
Go to Source

The European Medicines Agency recommends new advice to healthcare professionals to reduce the risk of adverse effects on the heart associated with the use of the multiple sclerosis (MS) treatment Gilenya (fingolimod).
Go to Source

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of a marketing authorisation for Forxiga (dapagliflozin), a novel treatment for type 2 diabetes mellitus.
Go to Source

This page lists the opinions adopted at the April 2012 meeting of the CHMP and other imporant outcomes.
Go to Source

The Committee on Herbal Medicinal Products (HMPC) at the European Medicines Agency has approved its 100th herbal Community monograph since the Committee began work in 2004.
Go to Source

The European Medicines Agency’s website, ema.europa.eu, will be unavailable from 13.00 until 17:30 on Thursday April 5, due to essential maintenance.
Go to Source

The European Medicines Agency has today published its updated policy on conflicts of interests of the scientific experts and committee members it uses in its work.
Go to Source

Go to Source

Go to Source

Go to Source

Go to Source

Go to Source

Go to Source

Go to Source

Go to Source

Go to Source

Go to Source

Go to Source

Go to Source

Go to Source

Go to Source

Go to Source

Go to Source

Go to Source

Go to Source

Go to Source

Go to Source

Go to Source

Go to Source

Go to Source

Go to Source

Go to Source

Go to Source

Go to Source

Go to Source

Go to Source

Go to Source

Go to Source

Go to Source