EGA INTRODUCES ITS CODE OF CONDUCT FOR THE EUROPEAN GENERIC AND BIOSIMILAR MEDICINES INDUSTRIES
Brussels, 5 March 2015 - Following the adoption of the European Commission Guiding Principles Promoting Good Governance in the Pharmaceutical Sector initiated by the Former Vice-President of the Commission, Antonio Tajani, the EGA (European Generic and Biosimilar medicines Association) is pleased to strengthen its commitment on ethics and transparency by introducing its Code of Conduct today.
New Landmark in fight against counterfeit medicines with establishment of the European Medicines Verification System
Brussels, 19 February - Major European healthcare stakeholders have taken a major step to secure the legitimate pharmaceutical supply chain against the risk of falsified medicines, as required by the EU Falsified Medicines Directive.
EGA HIGHLIGHTS THE PARTNERSHIP WITH THE EUROPEAN MEDICINES AGENCY ON ITS 20TH ANNIVERSARY
Brussels 26 January 2015 - The European Generic medicines Association (EGA) congratulates the European Medicines Agency (EMA) on the occasion of its 20th anniversary which occurs today. As an important organisation of scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union, the EMA plays a vital role in the process of medicine approval ensuring safety and quality across Europe.
STATEMENT ON GVK BIO EU REFERRAL - 23 JANUARY 2015
The European Generic medicines Association (EGA) and its members have an absolute commitment to quality for medicines in Europe. Further to the Committee for Human Medicinal Products (CHMP) opinion on the GVK CRO investigation which affects multiple marketing authorisations (MAs) in Europe, EGA members will act on the recommendations in conjunction with the competent authorities.
INDUSTRY AND REGULATORS PRIORITISE PATIENT ACCESS TO HIGH QUALITY MEDICINES AT EGA REGULATORY AND PHARMACOVIGILANCE FLAGSHIP EVENTS IN LONDON
London, 22 January 2015 - Over 60 authorities from 27 countries are attending the European Generic medicines Association (EGA) 14th Regulatory and Scientific Affairs Conference this week in London. This event, alongside the EGA 8th Pharmacovigilance Discussion Forum, brings together company executives, regulators, national authorities and other industry leaders to discuss key issues impacting the generic and biosimilar medicines industries.
26 - 27 March 2015
23 - 24 April 2015
30 April 2015
EGA Vision 2015, the Way forward for more Efficient Regulatory Environment for Generic and Biosimilar Medicines
GfK Final Report- Factors Supporting a Sustainable European Biosimilar Medicines Market
GfK Final Report- Factors Supporting a Sustainable European Biosimilar Medicines Market GfK Final Report- Factors Supporting a Sustainable European Biosimilar Medicines Market
Biosimilars: The science of extrapolation
Martina Weise, Pekka Kurki, Elena Wolff-Holz, Marie-Christine Bielsky, and Christian K. Schneider, Biosimilars: The science of extrapolation, Blood, 20 November 2014, Volume 124, NUMBER 22 Biosimilars_the_science_of_extrapolation.pdf
(free download for non-industry stakeholders only)
EGA Biosimilars Handbook
EGA Biosimilars Handbook English version EGA_BIOSIMILARS_handbook_en.pdf
EGA Biosimilars Handbook German version EGA_Biosimilars_ProGen-Biosimilars-A5-RZ-web_ende.pdf
EGA Biosimilars Handbook Italian version EGA_BIOSIMILARS_IT.pdf
EGA Biosimilars Handbook Spanish version EGA_BIOSIMILARS_INT_Spain.pdf