Publications

  1. 2016

    1. Sep 2016

    2. Aug 2016

      • 31st Aug 2016

        EFCG supports the USA’s Generic Drug User Fee Act (GDUFA)

        The European Fine Chemicals Group (EFCG) has agreed on terms for the reauthorisation of the US Food and Drug Administration’s (FDA’s) Generic Drug User Fee programme (GDUFA) for generic pharmaceutical substances from Fiscal Years 2018 to 2022.

    3. Jul 2016

    4. Jun 2016

      • 1st Jun 2016

        Mission accomplished: Patients are safer and the…

        In 2004 EFCG raised the first red flags about sub-standard Active Pharmaceutical Ingredients (APIs) entering Europe from India and China. Twelve years on, it appears that risks to patients from non-compliant bad quality APIs have been substantially reduced and that the playing field is levelling out.

    5. May 2016

      • 30th May 2016

        US FDA Quality Forum March 4th, 2016

        EFCG recently took part in a Quality Forum at the US FDA's headquarters in White Oak at the invitation of Dr. Janet Woodcock, Director of the US FDA Center for Drug Evaluation and Research (CDER). This is the presentation made by the FDA on that day

  2. 2015

    1. Oct 2015

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Latest News

  • In 2004 EFCG raised the first red flags about sub-standard Active Pharmaceutical Ingredients (APIs) entering Europe from India and China. Twelve years on, it appears that risks to patients from non-compliant bad quality APIs have been substantially reduced and that the playing field is levelling out.

     Read more...

  • EFCG Press Conference CPhI 2015: "API" day for Europe as Big Pharma returns in search of quality (by Dan Stanton)

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  • EFCG Press Conference CPhI 2015: Outlook in Europe for API Manufacturers is positive, says EFCG

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