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 published report on the International API inspection programme

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

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 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®.

First allogeneic stem cell therapy received approval in EU

stem cells
TiGenix NV and Takeda announced that the European Commission (EC) has approved Alofisel, previously Cx601, for the treatment of complex perianal fistulas in adult patients with nonactive/mildly active luminal Crohn’s disease.

EMA verified the withdrawal of Flupirtine analgesic

The Coordination Group for Mutual Recognition and Decentralised Procedures - Human has endorsed EMA’s recommendation to withdraw the marketing authorisation for the pain medicine, because of the risk of serious liver injury.

EMA accepts Astellas filing for review of prostate cancer drug

Astellas Pharma announced that the European Medicines Agency (EMA) has validated and started the review process for Astellas’ application for a Type II Variation for enzalutamide.

Novo Nordisk filed the approval submissions for a long-acting factor VIII

Novo Nordisk
Novo Nordisk announced the submission of a Biologics License Applications (BLA) to the US Food and Drug Administration (FDA) and a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA)

EMA gives orphan drug designation to Tocagen medicines

The European Medicines Agency has granted orphan medicinal product (orphan drug) designation to Toca 511 (vocimagene amiretrorepvec) & Toca FC (flucytosine)

EMA accepted the submission for AstraZeneca’s diabetes drug

AstraZeneca announced that the European Medicines Agency has accepted the Marketing Authorisation Variation for Forxiga (dapagliflozin) for use as an oral adjunct treatment to insulin in adults with type-1 diabetes (T1D).

EMA accepted the resubmission for review of Neulasta biosimilar

STADA Arzneimittel AG was informed by Gedeon Richter Plc. that the European Medicines Agency (EMA) has accepted the regulatory resubmission of its proposed biosimilar to Amgen's Neulasta (pegfilgrastim).

CHMP rejected Puma Biotechnology breast cancer drug

cancer treatment
Puma Biotechnology announced that the Committee for Medicinal Products for Human Use has adopted a negative opinion, recommending the refusal of the Marketing Authorisation Application for neratinib.

Iranian biosimilar company CinnaGen obtained GMP certification from EMA

The Iranian biosimilar company CinnaGen has achieved a notable first for the Middle East and North Africa (MENA) region.

EMA discussed its future premises in Amsterdam

european medicines agency
The European Medicines Agency’s Management Board met in an extraordinary session to discuss EMA’s future premises in Amsterdam. EMA will move from London to Amsterdam before the end of March 2019.