The EMEA and the FDA

J0403581 Last week, a report was issued by the Tufts Center for Drug Development that showed that while the European Medicines Agency (EMEA) – the European Union’s FDA equivalent – had met its performance goals, it was nevertheless lagging behind the FDA in approval times.

In terms of review times, the average in the EU was 15.8 months compared to 15.7 months in the US during the period of 2000-2005.  According to the report, the agencies approved 71 drugs, but 47 of those were approved more quickly by the FDA than by the EMEA. 

That said, if you compare the EMEA to the FDA for the matter of transparency, the FDA also wins hands down.  The FDA Web site, for instance, not only lists the meetings of advisory committees, but also posts the transcript of the meeting as well as the slides and supportive materials.  The FDA also posts the Warning Letters and has a vast Web site that provides information and therefore, an opportunity for learning.  The EMEA provides far fewer such opportunities and the Web site is not exactly consumer-friendly. 

One aspect where EMEA is ahead, is that all of the CVs of advisory members are posted on the site, while with FDA, the CVs of most, though not all, committee members are posted by FDA, though often not in a timely manner. 

In the column to your left, I have inserted a link to the EMEA and will add other European resources as I come across them.  If anyone knows of any good pharma sites in Europe, please let me know. 

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3 Responses to The EMEA and the FDA

  1. Joe Levy says:

    15.8 months vs 15.7 months? come on, it’s a 3 day difference.

  2. Mark says:

    Sorry, to be clear, it is the fact that FDA approved of 47 drugs more quickly than EMEA, not the average period of months.

  3. see comment in Lancet re transparency in Europe:
    Secrecy still an EU tradition?
    In their paper “Increased transparency in EU pharmaceutical code” (Lancet 2007; 369:88-90), G Pimpinella and R Bertini Malgarini from the Italian drugs agency have drawn a rosy picture of transparency on medicines in the EU.
    Experience of independent drug bulletins such as la revue Prescrire, who use regulatory information on a daily basis, shows a totally different reality. The European Medicines Agency’s website is far from helping the public and healthcare professionals to be properly informed: updates are not highlighted and are often posted with unacceptable delays. Key parts of EMEA documents are frequently missing, which leads to time-consuming requests.
    Transparency is a prerequisite for quality pharmacovigilance.1 In 2007 access to pharmacovigilance data from EMEA is poor. Real transparency would mean easy access to Periodic Safety Update Reports (PSURs).
    Theoretically all information on adverse drug reactions must be recorded in a database (EudraVigilance), provided for by article 57 of Regulation (EC) 726/2004 and “shall be permanently accessible to all Member States and without delay to the public” (article 102 of Directive 2004/27/EC). This provision has not been implemented.
    Transparency should also mean easy identification of EMEA and EU Commission measures by healthcare professionals and the public. The reasons underlying changes in a drug’s marketing approval because of safety concerns are still not fully explained by the European authorities. It would be helpful if at least the relevant parts of the summary of product characteristics were highlighted, so that healthcare professionals and patients can identify the most important and most recent decisions.
    Also transparency makes no sense if it does not help exclude members of EMEA Management Board with conflicts of interest. G Pimpinella and R Bertini Malgarini forgot to mention that the 2 representatives of patients in the Management Board of the European Medicines Agency (EMEA) belong to Alzheimer Europe and European Parkinsons Disease Association, i.e. 2 organizations that are notoriously funded by drug companies. There are patient organizations that are free of corporate influence in the EU. Representatives of patients should be chosen within the latter organizations so that patients’ interests are seen by European citizens to be the single priority.
    There are therefore many reasons to be dissatisfied with the way transparency provisions of the new Pharmaceutical code is implemented at the EMEA level. Mobilizing patient and professional organizations that are free of commercial influence is still needed in order to achieve real transparency and accountability of regulators in the EU.
    1- Prescrire Editorial Staff “La revue Prescrire contribution to Consultation on Pharmacovigilance in the EU” Prescrire International 2006; 15 (84): 154-153.

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