Press Releases
 2008
PRESS RELEASE | 10 December 2008
EGA WELCOMES EUROPEAN COMMISSION’S PHARMACEUTICAL PACKAGE, BUT MAINTAINS CERTAIN RESERVATIONS
The EGA welcomes the package of pharmaceutical legislation, but the association, which represents companies that produce nearly 50% of all medicines used in Europe, maintains major concerns about certain public health issues.
PRESS RELEASE | 8 December 2008
EGA WELCOMES WHO-IMPACT’S DEFINITION OF COUNTERFEIT MEDICINES
The EGA has welcomed the revised definition of a counterfeit medicine as “a clear and precise definition, practical in terms of enforcement, and ending confusion with alleged patent infringement products.”
PRESS RELEASE | 2 December 2008
Counterfeit Medicines—A Public Health Issue Needing Focused Solutions
“Confusion surrounding the term ‘counterfeit’ is diverting focus from the real problem of potentially dangerous medicines reaching patients”, says Greg Perry, Director General of EGA.
PRESS RELEASE | 28 November 2008
European Commission’s Inquiry Discloses Barriers to Rapid Access for Patients to Affordable Generic Medicines
DG Competition reports that delaying tactics by originator pharmaceutical companies cost society €3 billion.
PRESS RELEASE | 08 October 2008
2nd EGA Bioequivalence Forum in Paris Continues Successful Cooperation with EU Medicines Authorities on EU Guidelines
The EGA is holding its 2nd Bioequivalence
Forum today in cooperation with the Co-ordination Group for
Mutual Recognition & Decentralised Procedures for human medicines—the
CMD(h)—in
a joint effort to develop and improve the interpretation of guidelines
and standards within the bioequivalence arena.
PRESS RELEASE | 03 October 2008
2nd EMEA-EGA Info Day Confirms
Success of the Centralised Procedure
for Generic and Biosmilar Medicines
The Centralised Procedure is working well for both generic and biosimilar medicines; EMEA says “biosimilars is a success story”, foresees significant increases in generic and biosimilar applications in 2008-2009.
PRESS RELEASE | 02 October 2008
Patients Must Have Immediate Access to Affordable Generic Medicines at Day One After Patent Expiry
Speaking today at the final meeting of High Level Forum on Pharmaceuticals, EGA President Eric Gorka urged the national competent authorities and the European Commission to remove all anti-competitive barriers to immediate post-patent generic entry.
PRESS RELEASE| 26 September 2008 EGA Welcomes Approvals of Biosimilar Filgrastim
The EGA welcomes the European Commission’s approval of four new similar biological medicinal products containing recombinant human Granulocyte-Colony Stimulating Factor (G-CSF) as their active substance, also known under the international non-proprietary name (INN) “filgrastim”.
PRESS RELEASE | 25 September 2008
WTO Compusory Licenses System is Unworkable and Will Not Improve Access to Medicines
The WTO’s systme of compulsory licenses is complicated, unworkable and unable to deliver any significant improvement in access to medicines. Policy makers should significantly reform the provision and concentrate on reducing threats to generic medicines in bilateral trade agreements.
PRESS RELEASE: 8 July 2008
EGA WELCOMES THE ADOPTION OF THE REVISED VARIATIONS REGULATION
Considering it a “positive step” toward simplifying and optimising the system of changes to Marketing Authorisations, the EGA welcomes the European Commission’s adoption of the EU Regulation on Variations to marketing authorisations.
PRESS RELEASE: 19 June 2008
4th EGA SOUTH EAST EUROPEAN SYMPOSIUM:
“Meeting the European Challenge for the National Drug Regulatory Agencies and the Generic Medicines Industry”
Some 40 representatives of governmental agencies from throughout SE Europe are taking part in the two-day event. Greg Perry, director general EGA told the gathering, “The fact that many of you are gathered here in Istanbul for the fourth such event speaks clearly of your genuine interest in pursuing broader levels of regional cooperation in the field of affordable generic medicines.”
PRESS RELEASE: 5 June 2008
AFSSAPS—EGA INFO DAY: ONGOING JOINT
COOPERATION TO MEET GROWING EXPECTIONS
The AFSSAPS—EGA Info Day is the
first of a series of encounters between the national medicines authorities
and the European generic medicines industry.
PRESS RELEASE: 2 June 2008
NEW EGA REPORT IDENTIFIES PATENT-RELATED BARRIERS TO AFFORDABLE GENERIC MEDICINES
The European Generic medicines Association launched its latest report today on the IP barriers hindering the access of generic medicines to European markets and to patients.
PRESS RELEASE: 24 April 2008
BIOSIMILAR MEDICINES – DEVELOPING
MARKET PATHWAYS
THAT BENEFIT PATIENTS IS A SHARED RESPONSIBILITY
EGA Director General Greg Perry congratulated industry and EU medicines regulatory authorities today for further consolidating and developing the EU’s rigorously scientific “biosimilar thinking” during 2007.
PRESS RELEASE: 20 March 2008
THE EGA WELCOMES COMMISSION PROPOSAL AGAINST COUNTERFEITING OF MEDICINES — KEY ACTIONS AND INITIATIVES HIGHLIGHTED
The EGA considers the key proposals to be well designed to target the genuine problems underlying the counterfeiting of medicines.
PRESS RELEASE: 31 January 2008
EGA REITERATES LACK OF RESOURCES FOR NATIONAL REGULATORY AUTHORITIES AS MAJOR BARRIER TO NEW GENERIC MEDICINES
The EGA has reiterated its plea to the National Medicines Authorities to resolve their issues of resources to ensure the rapid and efficient approval of new generic medicines.
PRESS RELEASE: 16 January 2008
EUROPEAN COMMISSION INQUIRY
INTO COMPETITION IN THE PHARMACEUTICAL SECTOR
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