Subject :Clinical trials submitted in marketing authorisation applications to the EMA
Dear friends, Please find attached EMA report: Clinical trials submitted in marketing authorisation applications to the EMA. The revisions to the pharmaceutical legislation which came into force in 2005 increased emphasis on the ethical standards required of clinical trials conducted in third countries and included in marketing authorisation Applications (MAAs) submitted in the EU. There is growing concern both among regulators and in public debate about how well these trials are conducted from an ethical and scientific/organisational standpoint, including good clinical practice (GCP) compliance and about the available framework for the supervision of these trials. Information is required in each MAA regarding the location of conduct and ethical standards applied in respect of clinical trials conducted in third countries. Information on the geographic origins of patients recruited in the pivotal trials included in MAAs submitted to the centralised procedure has been collected since mid 2004. This report provides an overview of the distribution of the number of patients, investigator sites and pivotal clinical trials included in MAAs submitted to the EMA, on the number of sites subject to inspection and the geographic location of these inspections. This report was first published in 2009 with the data from MAAs submitted between 2005 to 2008. This second report is an update adding data from MAAs submitted in 2009. Kind regards,
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