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 New Drug Authorization Reports for 2019

EMA has published an overview of its key recommendations in 2019 on the authorisation and safety monitoring of medicines for human use and veterinary medicines. Innovative medicines are essential t...

EMA Accepted for Review MAA for Roclanda

EMA
Aerie Pharmaceuticals announced that the European Medicines Agency (EMA) has accepted for review the marketing authorization application (MAA) for Roclanda (netarsudil and latanoprost ophthalmic solut...

EMA Collaborates with Regulatory Bodies on Sterile Medicine Manufacturers Inspections

The European Medicines Agency (EMA) has announced that it will be collaborating with its international partners to launch a two-year pilot programme to increase co-operation for the inspection of ster...

Highlights of EMA Management Board December Meeting

EMA
The December meeting of EMA’s Management Board was hosted by the Dutch government as the Agency’s interim building is now closed to prepare for the move to the new EMA building in Amsterdam Zuidas in ...

EMA Validated BioMarin’s Application to Market Investigational AAV Gene Therapy

gene
The European Medicines Agency (EMA) has validated BioMarin’s application to market its investigational AAV gene therapy, valoctocogene roxaparvovec, for adults with hemophilia A. As such, the compa...

EMA Staff Reduced Following Departure from London

Following its Brexit-related departure from London, the European Medicines Agency’s (EMA) staff has been reduced from 897 staffers to 775, EMA said in an update from a board meeting in its new home in...

EMA Launched Pilot Programme on Cooperation in Sterile Medicines Production Inspections

sterile-manufacturing
EMA and its European and international partners are launching a pilot programme to increase their cooperation in the inspection of manufacturers of sterile medicines for human use. This new initiative...

Intercept Pharma Submitted Application to EMA for Obeticholic Acid

Intercept Pharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced that ...

ViiV Submitted Request to FDA and EMA for Dispersible Formulation of Dolutegravir

viiv healthcare
ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, announced it has made regulatory submissions to both the ...

EMA Recommended for Approval Five New Medicines

EMA
EMA’s human medicines committee (CHMP) recommended five medicines for approval at its December 2019 meeting. The Committee recommended granting a marketing authorisation for Beovu (brolucizumab) fo...

EMA Predicts Pharmacovigilance Contours in 2030

Smarter collection and reporting of safety reports of suspected adverse reactions, measurement of on-market performance of medicines, and improved engagement between regulators, patients and healthcar...

Results of EMA CVMP 3-5 December 2019 Meeting

EMA
CVMP adopts an updated advice on the categorisation of antibiotics in the European Union, and recommendations on the use of live attenuated PRRSV vaccines CVMP opinions on veterinary medicinal produ...

FDA and EMA Granted Orphan Drug Designation to Zotiraciclib

The FDA and EMA have granted Orphan Drug Designation to zotiraciclib, currently the subject of two separate Phase Ib clinical trials in glioblastoma. Zotiraciclib has been granted Orphan Drug...

EMA Agreed to Review Marketing Application for Amarin’s Vascepa

The European Medicines Agency (EMA) has agreed to review its marketing application for Amarin’s cardiovascular (CV) drug, Vascepa (icosapent ethyl). The regulatory organisation says that it is expe...

Bayer Submitted Application to EMA to Extend Xarelto Marketing Authorization

Bayer has submitted an application to the European Medicines Agency (EMA) to extend the Xarelto marketing authorization, making it available for children up to 17 years old with confirmed VTE, includi...

New Building Handed Over to EMA by Dutch Authorities

The Dutch authorities have handed over to EMA its newly built tailor-made premises, located in the Zuidas area of Amsterdam. Guido Rasi, EMA’s Executive Director, signed the lease agreement and thanke...