Provision of information on regulatory authorities' websites

A. Vitry, J. Lexchin, L. Sasich, T. Dupin-Spriet, T. Reed, V. Bertele, S. Garattini, L. Toop, E. Hurley

Research output: Contribution to journalArticle

Abstract

Background: 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. Methods: 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. Results: 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. Conclusion: Information on which regulatory authorities base their decisions for licensing new drugs and the rationales behind these decisions were often not publicly available.

Original languageEnglish
Pages (from-to)559-567
Number of pages9
JournalInternal Medicine Journal
Volume38
Issue number7
DOIs
Publication statusPublished - Jul 2008

Fingerprint

Canada
Pharmaceutical Preparations
France
Pharmacovigilance
Safety
Confidentiality
European Union
United States Food and Drug Administration
Licensure
New Zealand
Medicine
Organizations
Research
Surveys and Questionnaires

Keywords

  • Access to information
  • Internet
  • Medicine
  • Regulatory agency

ASJC Scopus subject areas

  • Internal Medicine

Cite this

Vitry, A., Lexchin, J., Sasich, L., Dupin-Spriet, T., Reed, T., Bertele, V., ... Hurley, E. (2008). Provision of information on regulatory authorities' websites. Internal Medicine Journal, 38(7), 559-567. https://doi.org/10.1111/j.1445-5994.2007.01588.x

Provision of information on regulatory authorities' websites. / Vitry, A.; Lexchin, J.; Sasich, L.; Dupin-Spriet, T.; Reed, T.; Bertele, V.; Garattini, S.; Toop, L.; Hurley, E.

In: Internal Medicine Journal, Vol. 38, No. 7, 07.2008, p. 559-567.

Research output: Contribution to journalArticle

Vitry, A, Lexchin, J, Sasich, L, Dupin-Spriet, T, Reed, T, Bertele, V, Garattini, S, Toop, L & Hurley, E 2008, 'Provision of information on regulatory authorities' websites', Internal Medicine Journal, vol. 38, no. 7, pp. 559-567. https://doi.org/10.1111/j.1445-5994.2007.01588.x
Vitry, A. ; Lexchin, J. ; Sasich, L. ; Dupin-Spriet, T. ; Reed, T. ; Bertele, V. ; Garattini, S. ; Toop, L. ; Hurley, E. / Provision of information on regulatory authorities' websites. In: Internal Medicine Journal. 2008 ; Vol. 38, No. 7. pp. 559-567.
@article{09586500e0854219b4078e177d9eb56c,
title = "Provision of information on regulatory authorities' websites",
abstract = "Background: 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. Methods: 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. Results: 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. Conclusion: Information on which regulatory authorities base their decisions for licensing new drugs and the rationales behind these decisions were often not publicly available.",
keywords = "Access to information, Internet, Medicine, Regulatory agency",
author = "A. Vitry and J. Lexchin and L. Sasich and T. Dupin-Spriet and T. Reed and V. Bertele and S. Garattini and L. Toop and E. Hurley",
year = "2008",
month = "7",
doi = "10.1111/j.1445-5994.2007.01588.x",
language = "English",
volume = "38",
pages = "559--567",
journal = "Internal Medicine Journal",
issn = "1444-0903",
publisher = "Wiley-Blackwell",
number = "7",

}

TY - JOUR

T1 - Provision of information on regulatory authorities' websites

AU - Vitry, A.

AU - Lexchin, J.

AU - Sasich, L.

AU - Dupin-Spriet, T.

AU - Reed, T.

AU - Bertele, V.

AU - Garattini, S.

AU - Toop, L.

AU - Hurley, E.

PY - 2008/7

Y1 - 2008/7

N2 - Background: 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. Methods: 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. Results: 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. Conclusion: Information on which regulatory authorities base their decisions for licensing new drugs and the rationales behind these decisions were often not publicly available.

AB - Background: 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. Methods: 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. Results: 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. Conclusion: Information on which regulatory authorities base their decisions for licensing new drugs and the rationales behind these decisions were often not publicly available.

KW - Access to information

KW - Internet

KW - Medicine

KW - Regulatory agency

UR - http://www.scopus.com/inward/record.url?scp=41749092580&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=41749092580&partnerID=8YFLogxK

U2 - 10.1111/j.1445-5994.2007.01588.x

DO - 10.1111/j.1445-5994.2007.01588.x

M3 - Article

C2 - 18336542

AN - SCOPUS:41749092580

VL - 38

SP - 559

EP - 567

JO - Internal Medicine Journal

JF - Internal Medicine Journal

SN - 1444-0903

IS - 7

ER -