Transparency of Regulatory Data Across the European Medicines Agency, Health Canada, and US Food and Drug Administration

Matthew Herder; Alexander C. Egilman; Amy Kapczynski; Margaret E. McCarthy; Anita T. Luxkaranayagam; Christopher J. Morten; Joshua D. Wallach; Joseph S. Ross

Transparency of Regulatory Data Across the European Medicines Agency, Health Canada, and US Food and Drug Administration

Matthew Herder
, Alexander C. Egilman
, Amy Kapczynski
, Margaret E. McCarthy
, Anita T. Luxkaranayagam
, Christopher J. Morten
, Joshua D. Wallach
, Joseph S. Ross

Research output: Contribution to journal › Article › peer-review

Abstract

Based on an analysis of relevant laws and policies, regulator data portals, and information requests, we find that clinical data, including clinical study reports, submitted to the European Medicines Agency and Health Canada to support approval of medicines are routinely made publicly available.

Original language	Canadian English
Journal	Articles, Book Chapters, & Popular Press
Publication status	Published - Jan. 1 2021

Keywords

Transparency
Clinical Trials
Regulatory Data
Medical Product Regulation
Public Health

Disciplines

Food and Drug Law
Health Law and Policy
Law
Medical Jurisprudence
Science and Technology Law

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Transparency of Regulatory Data Across the European Medicines AgeFinal published version, 343 KBLicence: Unspecified

Cite this

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title = "Transparency of Regulatory Data Across the European Medicines Agency, Health Canada, and US Food and Drug Administration",

abstract = " Based on an analysis of relevant laws and policies, regulator data portals, and information requests, we find that clinical data, including clinical study reports, submitted to the European Medicines Agency and Health Canada to support approval of medicines are routinely made publicly available.",

keywords = "Transparency, Clinical Trials, Regulatory Data, Medical Product Regulation, Public Health",

author = "Matthew Herder and Egilman, \{Alexander C.\} and Amy Kapczynski and McCarthy, \{Margaret E.\} and Luxkaranayagam, \{Anita T.\} and Morten, \{Christopher J.\} and Wallach, \{Joshua D.\} and Ross, \{Joseph S.\}",

note = "Alexander C Egilman et al, {"}Transparency of Regulatory Data Across the European Medicines Agency, Health Canada, and US Food and Drug Administration{"} (2021) 49:3 JL Med \& Ethics 456.",

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T1 - Transparency of Regulatory Data Across the European Medicines Agency, Health Canada, and US Food and Drug Administration

AU - Herder, Matthew

AU - Egilman, Alexander C.

AU - Kapczynski, Amy

AU - McCarthy, Margaret E.

AU - Luxkaranayagam, Anita T.

AU - Morten, Christopher J.

AU - Wallach, Joshua D.

AU - Ross, Joseph S.

N1 - Alexander C Egilman et al, "Transparency of Regulatory Data Across the European Medicines Agency, Health Canada, and US Food and Drug Administration" (2021) 49:3 JL Med & Ethics 456.

PY - 2021/1/1

Y1 - 2021/1/1

N2 - Based on an analysis of relevant laws and policies, regulator data portals, and information requests, we find that clinical data, including clinical study reports, submitted to the European Medicines Agency and Health Canada to support approval of medicines are routinely made publicly available.

AB - Based on an analysis of relevant laws and policies, regulator data portals, and information requests, we find that clinical data, including clinical study reports, submitted to the European Medicines Agency and Health Canada to support approval of medicines are routinely made publicly available.

KW - Transparency

KW - Clinical Trials

KW - Regulatory Data

KW - Medical Product Regulation

KW - Public Health

UR - https://digitalcommons.schulichlaw.dal.ca/scholarly_works/1332

M3 - Article

JO - Articles, Book Chapters, & Popular Press

JF - Articles, Book Chapters, & Popular Press

ER -

Transparency of Regulatory Data Across the European Medicines Agency, Health Canada, and US Food and Drug Administration

Abstract

Keywords

Disciplines

Access to Document

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