Tag: EMA

The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU), located in London. It began operating in 1995. The Agency is responsible for the scientific evaluation, supervision and safety monitoring of medicines developed by pharmaceutical companies for use in the EU.
EMA protects public and animal health in 28 EU Member States, as well as the countries of the European Economic Area, by ensuring that all medicines available on the EU market are safe, effective and of high quality.
EMA serves a market of over 500 million people living in the EU.

EMA survey displayed gaps in pharma industry preparedness for Brexit

european medicines agency
Regulatory authorities and marketing authorisation holders both play an important part in preparing for the consequences of Brexit to safeguard the continuous supply of medicines after the withdrawal of the UK from EU.

EMA reviews valsartan drugs after detecting an impurity

ema
The European Medicines Agency (EMA) is reviewing medicines containing the active substance valsartan that is supplied by Zhejiang Huahai Pharmaceuticals, a Chinese pharma company.

EMA recommended marketing authorization for the first stem cell veterinary drug

veterinary drug
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Veterinary Use (CVMP) has recommended a marketing authorization for the first veterinary stem cell-based medicine in the European Union (EU).

EMA held its 100th Management Board meeting

EMA
On June 6-7th, 2018, the European Medicines Agency (EMA) held the 100th meeting of its Management Board. Former chairs of the Board, plus all former Executive Directors of the Agency came to EMA to mark the occasion.

EMA and FDA accepted regulatory submissions for Pfizer’s cancer drug

cancer treatment
Pfizer announced that the FDA granted Priority Review designation to the company’s New Drug Application for talazoparib. The European Medicines Agency has also accepted the Marketing Authorization Application for talazoparib.

EMA withdraws the license from Taiwan’s pharma company

european medicines agency
The European Medicines Agency (EMA) is withdrawing the license of Taiwan-based Savior Liftec after the discovery of serious Good Manufacturing Practice (GMP) non-compliance after an inspection conducted earlier this month.

ViiV Healthcare received EU marketing authorisation for its HIV treatment

viiv healthcare
ViiV Healthcare, the global specialist HIV company, majority owned by GlaxoSmithKline, with Pfizer Inc. and Shionogi Limited as shareholders, announced that the European Commission has granted marketing authorisation for Juluca.

EMA issued its annual report for the year 2017

ema
The 2017 annual report provides an overview of the work of the European Medicines Agency (EMA) and highlights last year’s major achievements in protecting and promoting public and animal health in the European Union (EU).

EMA and The Netherlands completed the negotiations on a Seat Agreement

EMA
This is an important step in the relocation of EMA from London to Amsterdam as a result of Brexit. The Seat Agreement ensures that EMA can function properly and independently in the Netherlands.

EMA turns down approval of AB Science’s ALS drug

gcp
AB Science announced that the Committee for Medicinal Products for Human Use has adopted a negative opinion for the marketing authorization of masitinib in the treatment of adult patients with Amyotrophic Lateral Sclerosis (ALS).

EMA published report on the International API inspection programme

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The European Medicines Agency (EMA) and its European and international partners have successfully strengthened their interactions to improve the oversight of active pharmaceutical ingredient (API) manufacturers worldwide.

EMA will hold its second public hearing on antibiotics usage

antibiotic
The public hearing will give a voice to patients, doctors, nurses, pharmacists, researchers and everyone else who wants to share experience with quinolones and fluoroquinolones, a class of antibiotics widely prescribed in the EU.

EMA initiated a consultation focused on GMP non-compliance

european medicines agency
The European Medicines Agency (EMA) opened a public consultation period concerning the European Union’s template for Good Manufacturing Practice (GMP) noncompliance statements.

EMA and FDA accepted Pfizer’s submission for a review of lung cancer drug

pfizer
Pfizer announced that the U.S. FDA accepted the company’s New Drug Application and granted priority review for dacomitinib. EMA has also accepted the Marketing Authorization Application for dacomitinib for the same indication.

EMA published its current recommendations for the influenza vaccines

influenza vaccine
The European Medicines Agency (EMA) has issued the EU recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2018.

Biosimilar ABP 980 obtained a positive opinion from CHMP

cancer treatment
Amgen and Allergan have announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for the marketing authorisation of ABP 980, a biosimilar to Herceptin®.