Opportunities to improve the electronic reporting system for adverse drug reactions in Mexico: A comparative evaluation with the United States of America and the European Union-Reference-Cited by-同舟云学术

Opportunities to improve the electronic reporting system for adverse drug reactions in Mexico: A comparative evaluation with the United States of America and the European Union

Published:2020-08-24 Issue:11 Volume:29 Page:1523-1526
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiol Drug Saf

Author:

Cano‐Sandoval Miguel Á.¹,López‐Armas Gabriela C.²,Perfecto‐Avalos Yocanxóchitl³,Vázquez‐Alvarez Alan O.⁴,Brennan‐Bourdon Lorena M.⁵^ORCID

Affiliation:

1. Programa de Químico Farmacéutico Biotecnólogo, Escuela de Ciencias de la Salud, Campus Zapopan Universidad del Valle de México Zapopan Mexico

2. Plantel Colomos Centro de Enseñanza Técnica Industrial Guadalajara Mexico

3. Tecnologico de Monterrey Escuela de Ingeniería y Ciencias Guadalajara Mexico

4. Tecnologico de Monterrey, Escuela de Medicina y Ciencias de la Salud Guadalajara Mexico

5. Centro Estatal de Farmacovigilancia Comisión para la Protección Contra Riesgos Sanitarios del Estado de Jalisco (COPRISJAL) Guadalajara Mexico

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pds.5092

Reference15 articles.

1. International Conference on Harmonisation; Electronic Transmission of Postmarket Individual Case Safety Reports for Drugs and Biologics, Excluding Vaccines; Availability of Food and Drug Administration Regional Implementation Specifications for ICH E2B(R3) Reporting to the Food and Drug Administration Adverse Event Reporting System. Notice of Availability;Food and Drug Administration, HHS;Fed Regist,2016

2. EMA. History of EMA. European Medicines Agency 2018. Available at:https://www.ema.europa.eu/en/about-us/history-ema. Accessed July 31 2020.

3. Comisión Federal para la Protección contra Riesgos Sanitarios. NotiReporta.https://notireporta-cofepris.mx/. Accessed May 29 2019.

4. IHC Harmonised Tripartite Guideline. Maintenance of the ICH guideline on clinical safety data management: data elements for transmission of individual case safety reports E2B (R2). Current Step 4.2001.https://admin.ich.org/sites/default/files/inline-files/E2B_R2_Guideline.pdf.

5. Food and Drug Administration. Adverse Events Reporting System (FAERS) Public Dashboard.https://fis.fda.gov/sense/app/d10be6bb-494e-4cd2-82e4-0135608ddc13/sheet/7a47a261-d58b-4203-a8aa-6d3021737452/state/analysis. Accessed June 26 2020.

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