Generics medicines: a tradition of quality, safety & efficacy.

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What’s New...
on the EGA Web Site

Update ... April 2008

PRESS RELEASE: 24 April 2008

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.

EGA PRESENTATION: April 2008

EGA Presentation | Julie Maréchal, Sr Manager Regulatory Affairs,
• April 2008

Update ... March 2008

EGA PRESENTATION: March 2008

Elke Grooten, Director Pharmaceutical Policy, EGA
Presentation to the DIA Conference
• March 2008, Barcelona
 

EGA PRESENTATION: March 2008

Elke Grooten, Director Pharmaceutical Policy, EGA
Presentation to the DIA Conference
• March 2008, Barcelona
 

EGA POSITION: March 2008

• 13 March 2008
 

EMEA CONSULTATION: March 2008

...including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of Asthma and Chronic Obstructive Pulmonary Disease
EMEA, (COPD) CPMP/EWP/4151/00 Rev. 1
 

EMEA CONSULTATION: March 2008

EMEA, Ref: EMEA/CHMP/ICH/518819/2007
 

EMEA CONSULTATION: March 2008

EMEA, Ref: EMEA/CHMP/CVMP/QWP/450653/2006
 

EGA PUBLICATION: March 2008

“The EGA and EU Medicines Authorities Vow Joint Effort to Develop Greater Regulatory Efficiency for Generic Medicines”
 

PRESS RELEASE: 20 March 2008

The EGA considers the key proposals to be well designed to target the genuine problems underlying the counterfeiting of medicines.
 

WEBSITE SECTION UP-DATE

• Draft Proposal: Variations Regulation
• Commission's Impact Assessment
• EGA Positions on the proposals
• EGA Presentation on Variations and the Draft legislation
• Presentation of the issues and the procedure
 

NEW DOCUMENT

Pharmacovigilance Working Party
• January 2008
 

EGA PRESENTATION

• Beata Stepnewska, Director of Regulatory Affairs, EGA
   Presentation to the DIA Conference, Barcelona
   3 March 2008

EGA PRESENTATION

• Suzette Kox, Sr Director Scientific Affairs, EGA
   Presentation to the DIA Conference
   March 2008, Barcelona
 

EGA POSITION

EGA comments to A/PHI/IGWG/2/Conf Paper No 1 - Rev 1
Draft Global Strategy and Plan of Action
• March 2008

Update ... January 2008

PRESS RELEASE: 31 January 2008

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.

EGA POSITION: 29 January 2008

The Commission’s proposals have been well received by EGA members as they support the strategy to better protect public health by strengthening and rationalising EU Pharmacovigilance.

PRESS RELEASE: 16 January 2008

Update ... December 2007

EGA NEWS: 29 November 2007

Mr Hiroyuki Sawai accepts membership during the 10th Annual IGPA Conference in Miami.
 

Update ... November 2007

PRESS RELEASE: 21 November 2007

The European Generic medicines Association (EGA) launched its handbook on biosimilar medicines today in Brussels.
 

PRESS RELEASE: 21 November 2007

The European Generic medicines Association (EGA) has elected Eric Gorka, Head Commercial Operations EMEA for Sandoz International, as its new president.
 

Update ... October 2007

PRESS RELEASE: 23 October 2007

The CMD(h) has agreed to participate with the European generic medicines industry to improve the interpretation of guidelines and standards within the bioequivalence arena.
 

Update ... September 2007

PRESS RELEASE: 20 September 2007

The European Generic medicines Association (EGA) has today launched a plan to establish a supply chain integrity pact to fight the counterfeiting of pharmaceuticals.
 

PRESS RELEASE: 3 September 2007

The new biosimilar medicines, based on one development, have been shown to match a previously approved reference product in terms of quality, safety and efficacy...
 

Update ... June 2007

PRESS RELEASE: 26 June 2007

Speaking today at the High Level Forum on Pharmaceuticals, EGA President Emile Loof urged European medicines regulators not to link the price of generic medicines to the price of their corresponding originator products.

EGA POSITION: 26 June 2007

EGA POSITION: 26 June 2007

In response to the European Commission Report on current practices with regard to the provision of information to patients on medicinal products.

EGA PRESENTATION: 19-20 April 2007

Informal consultation of working group on regulatory evaluation of therapeutic biological medicines
• WHO - Geneva

EGA PRESENTATION: 19-20 April 2007

Informal consultation of working group on regulatory evaluation of therapeutic biological medicines
• WHO - Geneva

EUROPEAN PARLIAMENT: 5 June 2007

Presentation by Greg Perry, Director General of the European Generic medicines Association (EGA), to the European Parliament’s Mini-Hearing on TRIPS and Access to Medicines.
• 5 June 2007 Brussels

Update ... May 2007

PRESS RELEASE: 24 May 2007

Greg Perry praised representatives from thirteen regional medicines agencies for their commitment to understanding EU legislation, and cautioned against adopting provisions which could negativly impact the availability of affordable generic medicines in the region.

PRESS RELEASE: 14 May 2007

Greg Perry, EGA Director General, presents the generic medicines industry's position on anti-counterfeiting policy at the European Parliament, expressing strong support for Europe’s record of protecting pharmaceutical supplies from counterfeiters.

EGA POSITION

In response to the European Commission’s Consultation for DG ENTR Study on Distribution Channels - Part I: Combating Counterfeit Medicines’
• April 2007

PRESS RELEASE: 3 May 2007

Now that the science and the regulatory pathway have been established in the EU, industry and regulators must focus on building a “market pathway” for biosimilar medicines.

Update ... April 2007

EU COMMISSION TESTIMONY

• Nicolas Rossignol - April 2007
 

EGA POSITION

EGA Position
• April 2007
 

EGA CODE OF CONDUCT

The European Generic medicines Association, EGA, and its members recognise the importance of providing accurate, fair and objective information concerning medicinal products...
EGA Document
• 8 March 2007

Update ... February 2007

PRESS RELEASE: 13 February 2007

While praising EU regulators for the smooth implementation and running of the new Decentralised Procedure (DCP), the EGA is concerned about the serious lack of resources available to Member State agencies to deal with the regulatory workload.

The generic medicines industry is concerned that certain product changes, which claim to bring innovation, in fact offer little added benefit to patients.
EGA Position
• 20 January 2007

Update ... January 2007

MARKET REPORT

Dramatic changes in pharmaceutical markets make it imperative for generic medicines producers to develop, manufacture and market their products under the best possible conditions...
• Journal of Generic Medicines
  October 2006 (with permission)

BIOSIMILAR MEDICINES

Cecil Nick - PAREXEL Consulting, Uxbridge UK
• Published as Clinical Research Manual Supplement 21
   Copyright © 2006 - Euromed Communications (with permission)

Update ... December 2006

EGA POSITION PAPER: December 2006

EGA POSITION PAPER: October 2006

EGA POSITION PAPER

EGA POSITION PAPER

EGA POLICY PRESENTATION

EGA POSITION PAPER

NEW EGA WEB PAGE

Given the importance of the dynamic field of biosimilar medicinal medicines, a new section has been created on the EGA website to provide information on the latest developments in the area. Click “BIOSIMILARS” on the menu bar.

PRESS RELEASE: 5 December 2006

European producers of biosimilar medicines have raised doubts over the reliability of a paper launched today by the International Alliance of Patients’ Organisations (IAPO).

Update ... November 2006

REQUEST FOR PROPOSALS: 22 November 2006

EGA RESEARCH PROJECT

BARRIERS TO GENERIC PHARMACEUTICAL COMPETITION IN EUROPE
The EGA is announcing a call for tenders to commission a wide-ranging report on perceived barriers to the market entry of generic medicines in Europe. The report will likely cover issues such as ...     More...
 

Update ... October 2006

DOCUMENTS: 13 October2006

These include a list of products with the exact date of PSUR Submission.

NEW EVENT: EGA Members Only
London: 24 November 2006

“Generic and Biosimilar Medicines in the Centralised Procedure”

POSITION PAPER: October2006

• Posted on the EGA Position Papers page.

Update ... September 2006

PRESS RELEASE: 29 September 2006

EGA President Emile Loof underscored the critical role of generic medicines in sustaining healthcare provision and in stimulating innovation.

EGA NEWS: 29 September 2006

Greg Perry, Director General of the European Generic medicines Association, Outlines the Association's Top 10 Priority Areas by way of summarising the 12th EGA Annual Meeting in Budapest.

PRESS RELEASE: 28 September 2006

The EGA welcomes the decision by the European Patent Office to revoke "Citalopram crystalline base" patent for lack of inventive step.

PRESS RELEASE: 22 September 2006

EGA President Emile Loof calls upon the entire pharmaceutical industry to join forces against the problem of counterfeit medicines.

EGA PUBLICATION: September 2006

EGA FOCUS on Generic Medicines — No. 5

PRESS RELEASE: 19 September 2006

The Executive Committee of the European Generic medicines Association (EGA) has voted unanimously to grant the 2006 edition of the EGA Award to the Business Humanitarian Forum (BHF).

Update ... July 2006

EGA POSITION: May 2006

EGA Position Paper in Response to the European Commission Public Consultation
• 12 May 2006

EGA POSITION: July 2006

An important means to fight against counterfeiting is to secure the supply chain by introducing safer business processes.

EGA NEWS: July 2006

EGA Vows Continued Support for International Generics Cooperation through the International Generic Pharmaceuticals Association (IGPA).

Update ... May 2006

PRESS RELEASE: 18 May 2006

At the opening of the 4th Annual EGA Symposium on Biosimilar Medicines in London, the EGA welcomed the European Commission’s recent approval of two biosimilar products as vindication of their belief in the ability of science to demonstrate comparability.

PRESS RELEASE: 3 May 2006

EU Accession Countries must to be wary of creating obstacles to the production of generic medicines when adapting their legislation to the acquis communautaire.

Update ... April 2006

KATHOLIEKE UNIVERSITEIT LEUVEN: April 2006

This study shows how added savings of 27%-48% can be attained if the appropriate measures are taken. Coordinated government policies are critically needed in many EU countries to foster a sustainable generic medicines industry that plays an important role in the overall competitiveness of the EU pharmaceutical industry.

PRESS RELEASE: 6 April 2006

A new study by the Katholieke Universiteit Leuven shows that added savings of 27%-48% could be attained if the appropriate measures were taken by EU Member States.

• KUL Report on Measures to Promote Generics • Patent Linkage
• Biosimilars: Access to Medicines and EU Competitiveness

Update ... February 2006

PRESS RELEASE: 2 Febraury 2006

Greg Perry, Director General of European Generic medicines Association, announced today in London that growing pressure on European medicines authorities to apply patent linkage constitutes one of the biggest threats currently facing the generic medicines industry.

Update ... December 2005

PRESS RELEASE: 9 December 2005

Greg Perry, Director General of EGA, announced in Paris that biosimilars, the next generation of affordable medicines, are no longer a distant dream, but rather a soon to be realised reality.

Update ... November 2005

PRESS RELEASE: 10 November 2005

Greg Perry, Director General of the EGA has called for a sweeping review of the patent system to eliminate abuse and to ensure a more ethical use of the world’s technological heritage.

Update ... October 2005

PRESS RELEASE: 13 October 2005

Greg Perry, Director General of EGA, speaking to journalists in Finland today, called upon “all sectors to work together” to ensure equitable access to medications for all EU citizens.

PRESS RELEASE: 5 October 2005

Greg Perry, Director General of EGA, stressed today that the “devil is in the detail” when it comes to ensuring the success of the new medicines legislation. The key lies in avoiding a labyrinth of potential pitfalls ...

Update ... September 2005

PRESS RELEASE: 8 September 2005

“This Regulation will provide a better environment with stronger safeguards against abuse than similar legislation in the United States”, says Greg Perry, Director General of the EGA.

PRESS RELEASE: 2 September 2005

On September 7th the European Parliament will vote in First Reading on an important piece of legislation designed to provide better medicines for children in the EU...

EU PAEDIATRICS REGULATION: 2005/08/29

EGA Policy Recommendation for the Parliament's First Reading Plenary Vote - 6 September 2005
• August 2005

Update ... August 2005

LATEST STATISTICS: 2005/08/22

The latest market figures on the generic medicines industry in Europe.
• August 2005

Update ... July 2005

JOINT PRESS RELEASE: Kabul, 5 July 2005

• Public-private partnership equips Afghani population to produce safe and effective generic medicines.
• Medicines production equipment donated by EGA arrives in Kabul

Update ... June 2005

PRESS RELEASE: 20 June 2005

“The EU’s pricing and reimbursement systems for pharmaceutical products are hindering competition in the sector and interfering with the creation of optimum conditions for delivering affordable quality healthcare in the EU”.

PRESS STATEMENT: 16 June 2005

NEWS ITEM: 10 June 2005

Discussions focus on implementation of the new EU pharmaceutical legislation and its implications on access to cost-effective generic medicines in Europe.

NEWS ITEM: 9 June 2005

EGA joins debate on “Today and Tomorrow of the Polish Generic Medicines Industry in the Enlarged EU”

Update ... May 2005

PRESS RELEASE: 27 May 2005

The EGA has insisted today on the need to follow sound science when laying out the guidelines for “biogeneric” medicines in Europe. The EGA calls on EU medicines authorities to ensure the full participation of the biogeneric industry in all relevant debates.

ARTICLE: 2005/05/11

Barbara Bertholet - Avocate associée, Adamas Law Firm
• Article published in BIOTECHNOLOGIES & FINANCES - No 243
   2 mai 2005 (reproduced with permission)

NEW STATISTICS: 2005/05/02

The latest market figures on the generic medicines industry in selected countries.
• March 2005

Update ... April 2005

PRESS RELEASE: 2005/04/26

The Rapporteur has missed an excellent opportunity to turn the Commission's proposal into a win-win situation for healthcare systems, taxpayers and—more importantly—for children.

NEWS ITEM: 2005/04/21

EGA co-organised the symposium with the ABPhM in Sofia, Bulgaria on the theme “Meeting the European Challenge for the National Drug Regulatory Agencies and the Generic Medicines Industry”.

NEW DOCUMENT: 2005/04/12

Update ... March 2005

NEW DOCUMENT: 2005/03/22

Cecil Nick, BSc (Hons.) FTOPRA, Director PAREXEL Consulting

NEW CONSULTATION DOCUMENT: 2005/03/22

Ref: EMEA/CHMP/BWP/49348/2005
• Released for consultation: March 2005
• Deadline for comments: 30 June 2005

SITE DEVELOPMENT: 2005/03/10

Links to the Web sites of all EGA member companies and associations have now been included or up-dated.

EGA PUBLICATION: 2005/03/12

EGA FOCUS on Generic Medicines — No. 2

NEWS ITEM: 2005/03/10

• Report and Photos

SITE DEVELOPMENT: 2005/03/10

The “News Room ” (formerly “Press Room”) has been reorganised to include information on EGA Activites, as well as access to major EGA Publications, the latest EGA Press Releases and the EGA e-News archives.

Update ... February 2005

London: 26-27 May 2005

• Programme Details
• Register On-line
• Hotel Information & Booking

Media partner
3rd EGA Biogenerics
Symposium

Update ... January 2005

NEW DOCUMENT: 2005/01/15

HEALTH IN PORTUGAL “We trust generics.”

Luís Filipe Pereira, Health Minister, on the success of Portuguese generics policy.

• Keynote Address   [EN] [PT]

Update ... 15 December 2004

DOCUMENTS ADDED:

Ref: CHMP/437/04

Ref: CHMP/Comparability Working Party/146710/2004

Ref: CHMP/Comparability Working Party/146701/2004

Ref: CHMP/Comparability Working Party/146664/2004

Ref: CHMP/Comparability Working Party/146489/2004 corr.

Update ... 29 November 2004

NEW DOCUMENT: 2004/11/29

In his opening keynote address to EGA's Annual Conference 2004, the Dutch minister for health, J.F. Hoogervorst, urges generics manufacturers to continue “Meeting the Challenge” of making medicines affordable.

EGA CONFERENCE UP-DATE:
London: 2 February and 3-4 February 2005

Hotel Radisson SAS Portman, London,UK

Update ... 18 November 2004

PRESS RELEASE: 2004/11/18

The 2004 edition of the EGA Award has been granted jointly to Commissioners Erkki Liikanen and David Byrne for their role in establishing and supporting the G10 High Level Group on Medicines initiative.

PAEDIATRICS - NEW DOCUMENTS: 2004/11/18

BIOGENERICS - NEW SUBHEADING: 2004/11/18

• Current Legal Framework
• Legal Framework as of 1 November 2005
• EU Regulatory Pathway for Biogenerics

Update ... 10 November 2004

PRESS RELEASE: 2004/11/10

The EGA elected Mr Emile Loof, president of Pharmachemie BV of the Netherlands, as president of the EGA for 2004-2006. Mr Loof was elected on 9 November, immediately following the 10th Annual EGA Conference in Amsterdam, where government and industry representatives showed evidence of the benefits generated from measures promoting generic medicines in the EU.

Update ... 2 November 2004

PRESS RELEASE: 2004/11/02

The EGA welcomes the European Commission’s proposed Regulation on Compulsory Licensing which will allow the manufacture and export of generic versions of patented medicines to developing countries facing important health needs.

SITE DEVELOPMENT: 2004/11/02

A new section has been created on the EGA Web site featuring the European Commission’s proposal for a Regulation on Paediatric Medicines and background documents. Check under “Documents & Positions/Legislative Proposals”

PAEDIATRICS - NEW DOCUMENT: 2004/11/02

Article by Nadene McClay, published in the Journal of Generic Medicines, July 2004.

Update ... 29 October 2004

PRESS RELEASE: 2004/10/29

Greg Perry, Director General of EGA, today received the Golden Cross of Merit of the Republic of Poland in recognition of exceptional services to Poland in relation to the country’s accession to the European Union.

SITE DEVELOPMENT: 2004/10/29

A user-friendly search engine has been added to the EGA Web Site to make it easier to navigate the growing number of documents on these pages.

Update ... 29 September 2004

PRESS RELEASE: 2004/09/29

The EGA welcomes the European Commission's draft Regulation on paediatric medicines, while urging improvements to the proposal to maximise benefits to children.

Update ... 1 September 2004

PRESS RELEASE: 2004/09/01

The EGA has revised its logo, incorporating the image of a "capsule" to make the EGA more instantly recognisable as an organisation dedicated to the provision of affordable medicines.

Update ... 12 July 2004

MRFG DOCUMENT: May 2004

MRFG DOCUMENT: May 2004

Update ... 1 July 2004

PRESS RELEASE: 2004/07/01

The increasing number of patents on minute and obscure aspects of pharmaceutical products is fast becoming the principle obstacle facing the industry. This not only keeps the cost of medicines unnecessarily high, but more worryingly, it eliminates the stimulus to discover new cures for life-threatening illnesses.

Update ... 21 June 2004

Intellectual Property

Over 8300 Supplementary Protection Certificates have been filed since 1991 — nearly 400 in 2003 alone. Who is filing them? Where? And for which products?

Science and Regulatory

by Paul Chamberlain, A.R Mire-Sluis, and Robert Zeid.

Includes the agreed policy for the population of the EVMPD (EudraVigilance Medicinal Product Dictionary).

Update ... 6 June 2004

PRESS RELEASE: 2004/06/03

PRESS RELEASE: 2004/05/14

May 2004 - A New Web Presence for a New Europe

What’s new? Just about everything!

The European Union now has 10 new Member States, and it will soon have a new Commission and a new Parliament. What better time for the European Generic medicines Association to create a new, fresh presence on the internet to provide users with the latest news and documentation on generic medicines and the pharmaceuticals industry.

Special Features

In addition to featuring a fresh, new look and feel, user-friendly navigation bars, and standards-based structural design, the new EGA Web site is full of new information. Here are just a few of the interesting new features the site has to offer:

This area will answer most questions you might have about the EGA, its mission, its members and the range of its activities aimed at developing affordable solutions to European healthcare policy.

Written for the educated layman, the series of articles in this section provides a thorough background to the generics industry and the issues facing it. Short on time? Start with the Basic Notions page or the FAQ. And the Glossary will help clarify many of the specialist terms and acronyms that are unavoidable.

And you will not want to miss the 5-minute EGA Video Profile on “Making Medicines Affordable”.

This is where industry experts, pharmaceuticals professionals and policy-makers will find the latest scientific and legal documentation pertaining to legislative, regulatory and scientific issues. EGA’s most recent position papers and policy briefings will also be made public here. This section, along with Facts & Figures, will be updated regularly, so you will want to check back frequently.

The most recent additions and modifications to the EGA Web site will be listed at the top this “WHAT’S NEW?” page.