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margin-top:2.25pt;
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margin-right:326.05pt;
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margin-bottom:0cm;
margin-left:6.0cm;
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margin-right:6.0cm;
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mso-style-parent:"Body text";
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margin-right:.55pt;
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mso-pagination:widow-orphan;
page-break-after:avoid;
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mso-fareast-language:EN-US;}
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mso-style-update:auto;
mso-style-parent:"";
margin-top:24.0pt;
margin-right:0cm;
margin-bottom:12.0pt;
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{mso-style-name:"David Legge";
mso-style-parent:"First para";
margin-top:12.0pt;
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margin-bottom:12.0pt;
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mso-pagination:widow-orphan;
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span.Referencesuperscript
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span.Referencesuperscript1
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p.Table, li.Table, div.Table
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margin-right:2.85pt;
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<div class=Section1>
<p class=MsoNormal><b><font size=2 color="#333333" face=Arial><span
style='font-size:10.0pt;font-family:Arial;color:#333333;mso-ansi-language:EN-US;
font-weight:bold'>Provision of information on regulatory authorities’
websites<o:p></o:p></span></font></b></p>
<p class=MsoNormal><font size=1 color="#333333" face=Arial><span
style='font-size:7.0pt;mso-bidi-font-size:10.0pt;font-family:Arial;color:#333333;
mso-ansi-language:EN-US'>A. Vitry, <span style='mso-spacerun:yes'> </span>J.
Lexchin, L. Sasich, T. Dupin-Spriet, T. Reed, V. Bertele, S. Garattini, L. Toop
, E. Hurley <o:p></o:p></span></font></p>
<p class=MsoNormal><font size=1 color="#333333" face=Arial><span
style='font-size:7.0pt;mso-bidi-font-size:10.0pt;font-family:Arial;color:#333333;
mso-ansi-language:EN-US'>Internal Medicine Journal <o:p></o:p></span></font></p>
<p class=MsoNormal><font size=1 color="#333333" face=Arial><span
style='font-size:7.0pt;mso-bidi-font-size:10.0pt;font-family:Arial;color:#333333;
mso-ansi-language:EN-US'>Vol 38, Issue7, pp 559-567<o:p></o:p></span></font></p>
<p class=MsoNormal style='margin-bottom:4.8pt;mso-outline-level:2'><b><font
size=1 color="#336699" face=Arial><span style='font-size:7.5pt;font-family:
Arial;color:#336699;mso-font-kerning:18.0pt;mso-ansi-language:EN-US;font-weight:
bold'><o:p> </o:p></span></font></b></p>
<p class=MsoNormal style='margin-bottom:4.8pt;mso-outline-level:2'><b><font
size=1 color="#336699" face=Arial><span style='font-size:7.5pt;font-family:
Arial;color:#336699;mso-font-kerning:18.0pt;mso-ansi-language:EN-US;font-weight:
bold'>ABSTRACT<o:p></o:p></span></font></b></p>
<p class=MsoNormal style='mso-margin-bottom-alt:auto'><b><font size=3
color="#333333" face=Arial><span style='font-size:12.0pt;mso-bidi-font-size:
12.0pt;font-family:Arial;color:#333333;mso-ansi-language:EN-US;font-weight:
bold'>Background: </span></font></b><font size=1 color="#333333"
face=Arial><span style='font-size:7.0pt;font-family:Arial;color:#333333;
mso-ansi-language:EN-US'>Several organizations have raised concerns about the
excessive secrecy maintained by regulatory authorities around the world, in
particular in the European Union, France, UK, Canada and Australia. However,
limited research has assessed the provision of information by regulatory
authorities. This study aimed to assess the type and availability of
information provided on the regulatory authorities' websites.<o:p></o:p></span></font></p>
<p class=MsoNormal style='mso-margin-bottom-alt:auto'><b><font size=3
color="#333333" face=Arial><span style='font-size:12.0pt;mso-bidi-font-size:
12.0pt;font-family:Arial;color:#333333;mso-ansi-language:EN-US;font-weight:
bold'>Methods: </span></font></b><font size=1 color="#333333" face=Arial><span
style='font-size:7.0pt;font-family:Arial;color:#333333;mso-ansi-language:EN-US'>Regulatory
authorities' websites in six countries (USA, Canada, UK, France, Australia and
New Zealand) and at the European level (European Medicines Evaluation Agency)
were surveyed by two reviewers between October 2005 and March 2006. The survey
instrument included 16 criteria organized in 3 domains: information on marketed
drugs, information on assessment of drugs and information on drug safety.<o:p></o:p></span></font></p>
<p class=MsoNormal style='mso-margin-bottom-alt:auto'><b><font size=3
color="#333333" face=Arial><span style='font-size:12.0pt;mso-bidi-font-size:
12.0pt;font-family:Arial;color:#333333;mso-ansi-language:EN-US;font-weight:
bold'>Results: </span></font></b><font size=1 color="#333333" face=Arial><span
style='font-size:7.0pt;font-family:Arial;color:#333333;mso-ansi-language:EN-US'>There
was a great variability in the level of information provided. Several medicine
agencies did not provide basic information on marketed drugs, such as the
summary of products' characteristics. Information on registration dossiers was
scant on most websites except that of the US Food and Drug Administration. The
European Medicines Evaluation Agency, the French agency and the Canadian agency
released public assessment reports that contained only summarized information
of registration data. Only one country, Canada, provided full access to
pharmacovigilance data. The periodic safety update reports that companies have
to provide regularly to regulatory authorities were not available in any
country.<o:p></o:p></span></font></p>
<p class=MsoNormal style='mso-margin-bottom-alt:auto'><b><font size=3
color="#333333" face=Arial><span style='font-size:12.0pt;mso-bidi-font-size:
12.0pt;font-family:Arial;color:#333333;mso-ansi-language:EN-US;font-weight:
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face=Arial><span style='font-size:7.0pt;font-family:Arial;color:#333333;
mso-ansi-language:EN-US'>Information on which regulatory authorities base their
decisions for licensing new drugs and the rationales behind these decisions
were often not publicly available.<o:p></o:p></span></font></p>
<p class=MsoNormal><font size=2 face=Arial><span style='font-size:10.0pt;
font-family:Arial;mso-ansi-language:EN-US'><o:p> </o:p></span></font></p>
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