Generic medicines, affordable solutions.
Scientific|Regulatory
OverviewIntellectual Property
OverviewPharma Review
ResultsLegislative Initiatives
VariationsEGA Position Papers
OverviewPositions & Documents
EGA Position Papers
- While many EGA papers are referenced throughout the EGA Web site, this area provides users with a handy “one-stop shop” for all of our policy documents.
|Overview|
Pharmaceutical Forum | Biosimilar Medicines | Pharmacovigilance |
| Regulatory | Good Manufacturing Procedure & Inspections |
| Paediatrics | Marketing
Authorisation & Englargement |
| Data Exclusivity | Anti-Counterfeiting |
IP - Patents |
| Criminal Measures to Enforce IP Rights (IPRED2)
|
| IP Enforcement | TRIPS - Doha Agreement |
Scientific & Regulatory Issues
- Ensuring the quality, safety and efficacy of medicinal products is the fundamental responsibility of Europe’s medicines authorities, combined with the responsible corporate behaviour of medicines manufacturers. This area keeps up to date with the latest developments in the field of pharmaceutical science and regulation.
|Overview|
Product Development|
Marketing Authorisation|
|Post-Authorisation Surveillance|
Intellectual Property
- Issues of Intellectual Property stand firmly at the heart of the debate on ensuring a steady supply of competitively-priced pharmaceutical products while stimulating research and development efforts to discover new cures and treatments.
|Overview|
General IP Issues|
TRIPS/Doha|
Patents|
|Data Exclusivity|
Access to Medicines|
Review of EU Pharmaceutical Legislation
- In July 2001 the European Commission published its proposal for a revision of the EU legislative framework governing pharmaceuticals. The results of the so-called “Pharma Review” and an analysis of the practical benefits this legislation will have on EU healthcare systems and pharmaceutical markets is documented here.
|Overview| Results of the Pharma Review|
Legislative Issues
- A catalogue of documentation and information on current and up-coming legislation of concern to Europe’s healthcare systems and the generic medicines industry.