TY - JOUR
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 -