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2004.12.08
pdf - 173k |
Launch of EFCG (CEFIC’s European Fine Chemicals Group)Presentation given on the 8th December 2004 to the press during CPHI Brussels, by Peter Nagler of Degussa.
EFCG calls for GMP inspections
Speaking at the formal launch of the European Fine Chemicals Group (EFCG) at CPhI Worldwide in Brussels on 8 December, Guy Villax, CEO of Portuguese fine chemicals manufacturer Hovione, summarised a case for better enforcement of GMP in API manufacturing by the European authorities. CEFIC's Active Pharmaceutical Ingredients Committee (APIC) and industry associations in Italy, Spain and Portugal have been putting this case to the EC.
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2004.12.10
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Launch of EFCG (CEFIC’s European Fine Chemicals Group)Presentation given on the 8th December 2004 to the press during CPHI Brussels, by Peter Nagler of Degussa.
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2004.12.20
pdf - 62k |
Launch of EFCG (CEFIC’s European Fine Chemicals Group)Presentation given on the 8th December 2004 to the press during CPHI Brussels, by Peter Nagler of Degussa.
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2004.12.20
pdf - 14k |
Launch of EFCG (CEFIC’s European Fine Chemicals Group)Presentation given on the 8th December 2004 to the press during CPHI Brussels, by Peter Nagler of Degussa.
Europese fijn-chemie producenten verenigen zich
Chemiezine. Om gezamenlijk het hoofd te bieden aan de toegenomen concurrentie en de veranderingen op de wereldmarkt hebben de producenten van fijn-chemie zich verenigd in de European Fine Chemicals Group (EFCG) binnen de European Chemical Industry Council (Cefic). De groep wil de stem van de producenten worden, effectiever zakendoen en beter gebruik maken van de bestaande lobby. Hiermee willen ze samen de effecten van de toegenomen lastendruk, het gebrek aan een level playing field en het uitbreiden van de innovatiecapaciteit van fijn-chemiebedrijven aanpakken.
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2004.12.17
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Launch of EFCG (CEFIC’s European Fine Chemicals Group)Presentation given on the 8th December 2004 to the press during CPHI Brussels, by Peter Nagler of Degussa.
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2005.07.05
pdf - 1,303k |
Launch of EFCG (CEFIC’s European Fine Chemicals Group)Presentation given on the 8th December 2004 to the press during CPHI Brussels, by Peter Nagler of Degussa.
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2005.11.03
pdf - 116k |
Launch of EFCG (CEFIC’s European Fine Chemicals Group)Presentation given on the 8th December 2004 to the press during CPHI Brussels, by Peter Nagler of Degussa.
EFCG’s simple guide
A simple guide to GMP compliant sourcing of APIs for manufacturers of medicines destined for the EU market.
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2005.11.03
pdf - 19k |
Launch of EFCG (CEFIC’s European Fine Chemicals Group)Presentation given on the 8th December 2004 to the press during CPHI Brussels, by Peter Nagler of Degussa.
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2005.11.04
pdf - 41k |
Launch of EFCG (CEFIC’s European Fine Chemicals Group)Presentation given on the 8th December 2004 to the press during CPHI Brussels, by Peter Nagler of Degussa.
Europe Makes Manufacturing Compliance An Obligation
European Union legislation now requires that all active pharmaceutical ingredients (APIs) going into drugs sold in Europe meet Good Manufacturing Practices (GMPs). The directive went into effect on Oct. 30, almost 50 years after the U.S. enacted similar rules. But rather than chafing under another regulation, the European Fine Chemicals Group (EFCG), an organization launched a year ago to represent fine chemicals manufacturers, is embracing it.
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2005.11.25
pdf - 18k |
Launch of EFCG (CEFIC’s European Fine Chemicals Group)Presentation given on the 8th December 2004 to the press during CPHI Brussels, by Peter Nagler of Degussa.
GMP directive 'toothless'
Chemistry & Industry, 21 November 2005, issue No. 22, page 7. The EU Good Manufacturing Practice (GMP) directive that came into force on 30 October has no teeth, according to the European Fine Chemicals Group (EFCG).
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2005.12.06
pdf - 699k |
Launch of EFCG (CEFIC’s European Fine Chemicals Group)Presentation given on the 8th December 2004 to the press during CPHI Brussels, by Peter Nagler of Degussa.
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2006.02.14
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Launch of EFCG (CEFIC’s European Fine Chemicals Group)Presentation given on the 8th December 2004 to the press during CPHI Brussels, by Peter Nagler of Degussa.
Garantir as GMP's precisa-se
Marketing Farmacêutico, Nº, 23, Fevereiro/Março, 2006, pág. 10-11. Depois de ter sido aprovada a 31 de Outubro de 2005, na Europa, uma lei que determina que sejam feitas inspecções à fonte dos princípios activos, o European Fine Chemicals Group (EFCG) propõe agora um guia simplificado à Indústria Farmacêutica. O documento tem como finalidade assegurar às empresas de produtos acabados que o fornecedor de substâncias activas está em conformidade com as Good Manufacturing Practices (GMPs, na designação anglo-saxónica).
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2006.03.29
pdf - 130k |
Launch of EFCG (CEFIC’s European Fine Chemicals Group)Presentation given on the 8th December 2004 to the press during CPHI Brussels, by Peter Nagler of Degussa.
GMP compliance of APIs - Finally!
Chimica Oggi / Chemistry Today, March/April 2006, vol. 24 (2). What is the EFCG and why was it created? The EFCG groups together, the companies and associations of fine chemical manufacturers in the European Chemical Industry Council (CEFIC), and the committee of which I am the Chairman represents over 200 European producers of APIs (active pharmaceutical ingredients and their precursors) located in the EU. We decided to create this group as we felt we had no representative voice in Brussels and we could not keep a passive position when facing an avalanche of legislation that strongly penalizes those who produce in Europe, and favours those who manufacture outside Europe and...
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2006.04.17
pdf - 193k |
Launch of EFCG (CEFIC’s European Fine Chemicals Group)Presentation given on the 8th December 2004 to the press during CPHI Brussels, by Peter Nagler of Degussa.
The EFCG Looks to Add Muscle to New European Legislation
Pharmaceutical Technology Sourcing and Management, Vol. 2 (3), March 2006. The European Fine Chemicals Group seeks to strengthen enforcement and compliance measures governing the supply of active pharmaceutical ingredients both from European and non-European manufacturing facilities.
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2006.05.10
pdf - 1,720k |
Launch of EFCG (CEFIC’s European Fine Chemicals Group)Presentation given on the 8th December 2004 to the press during CPHI Brussels, by Peter Nagler of Degussa.
EFCG and SOCMA Urge More Inspection of Foreign API Makers
Date: 2006.10.12 Pharmaceutical Technology. CPhI Worldwide, Paris (Oct. 3, 2006)—The Synthetic Organic Chemical Manufacturers Association (SOCMA, Washington, DC, www.socma.org) and the European Fine Chemicals Group (EFCG, Brussels, www.efcg.cefic.org) have teamed to urge US and European regulatory authorities to increase inspections of foreign manufacturing facilities of active pharmaceutical ingredients (APIs) to reduce patient risk from sub-par drugs, to increase national security, and to level the economic playing field
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2006.10.23
pdf - 25k |
Launch of EFCG (CEFIC’s European Fine Chemicals Group)Presentation given on the 8th December 2004 to the press during CPHI Brussels, by Peter Nagler of Degussa.
EFCG and SOCMA Urge GMPs for APIs
Date: 2006.10.03 Description: Pharma & Bio Ingredients. The European Union and the United States both have rules in place to ensure that active pharmaceutical ingredients – or APIs – used in the manufacturing of medicines meet the pharmaceutical industry’s accepted current good manufacturing practices (GMP). However, the U.S. Food & Drug Administration (FDA) and the European Union equivalent agencies do not inspect all foreign facilities manufacturing APIs serving them. According to a 1999 FDA report, 242 manufacturers imported in the United States without being inspected, these points were spelled out at a recent press conference held Oct. 3 at CPhI in Paris.
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2006.10.23
pdf - 44k |
Launch of EFCG (CEFIC’s European Fine Chemicals Group)Presentation given on the 8th December 2004 to the press during CPHI Brussels, by Peter Nagler of Degussa.
