EGA

EUROPEAN GENERIC MEDICINES ASSOCIATION

Making Medicines Affordable
 
 

IN THE SPOTLIGHT 8th EGA Legal Affairs Forum

 

 

 

EGA Q&A

 

NEW VERSION!

BIOSIMILARS HANDBOOK

This second edition of the EGA biosimilars handbook is intended to be a convenient and brief reference source for all those who need to understand biosimilar medicines, this relatively new subclass of biopharmaceutical products. It explains their importance and benefits and provides answers to the many questions raised by this vital new category of medicine. This handbook is particularly targeted towards all those groups that need to understand the background of biosimilar medicines 

- EGA Biosimilars Handbook can be purchased here.

- A Italian Version of the EGA Biosimilars Handbook coordinated by ASSOGENERICI can be purchased here.

NEW

EGA Submission regarding US Approval Pathway for Biosimilar and Interchangeable Biological Products (Docket N° FDA-210-N-0477)

Latest News

10th EGA International Symposium on Biosimilar Medicines

PRESS RELEASE | Rome - Brussels, 27 January 2012EUROPEAN COMMISSION AND MARIO MONTI’S GOVERNMENT SEEK TO INCREASE PATIENT ACCESS TO GENERIC MEDICINES

The European Generic medicines Association (EGA) together with the Italian association for generic medicines (ASSOGENERICI) welcome the European Commission’s formal call yesterday on Italy to comply with EU rules on the marketing authorisation of generic medicines. The European Commission infringement procedure started last year, following the EGA and ASSOGENERICI’s official complaint to the European Commission against the delays in granting market authorisation of generic medicines caused by incorrect linkage to intellectual property rights. More..

PRESS RELEASE | Warsaw, 12 October 2011

NEW EGA PRESIDENT PROMOTES VALUE AND GLOBALISATION

Gudbjorg Edda EggertsdottirMeeting today in Warsaw, the European Generic medicines Association’s Board announced the election of Gudbjorg Edda Eggertsdottir as its new President. Ms Eggertsdottir has been active in the generic medicines industry for over 30 years, witnessing the many challenges it has already faced on its way to becoming an essential part of the global healthcare offering. She has an impressive industry pedigree, which includes significant experience in the generic medicines sector in companies such as Actavis – where she is currently President Iceland, Strategic Projects – and Delta. Ms Eggertsdottir has been part of the EGA Executive Board for two years. More..

Leading Issues

EC Sector Inquiry into Pharmaceuticals

Publications

EGA VISION 2015, the way forward for a more efficient regulatory environment for generic and biosimilar medicines.

EGA Q&A on the Revised EMA Bioequivalence Guideline, the EGA Contribution to the Promotion of Harmonised EU Interpretatation of the Revised Bioequivalnce Requirements.

Forthcoming Events

Brussels8th EGA Legal Affairs Forum
Brussels | 22-23 MARCH 2012

London10th EGA International Symposium on Biosimilar Medicines
London | 19-20 APRIL 2012

Malta18th EGA Annual Conference
Malta | 13-15 JUNE 2012

More on the Events Page ››
 

“The EGA is the official representative body of the European generic and biosimilar pharmaceutical industry, which is at the forefront of providing
high-quality affordable medicines to millions of Europeans and stimulating competitiveness and innovation in the pharmaceutical sector.”