Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2020 Nov;29(11):1523-1526.
doi: 10.1002/pds.5092. Epub 2020 Aug 24.

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

Miguel Á Cano-Sandoval  1 , Gabriela C López-Armas  2 , Yocanxóchitl Perfecto-Avalos  3 , Alan O Vázquez-Alvarez  4 , Lorena M Brennan-Bourdon  5
Affiliations

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

Miguel Á Cano-Sandoval et al. Pharmacoepidemiol Drug Saf. 2020 Nov.
No abstract available

PubMed Disclaimer

References

REFERENCES

    1. Food and Drug Administration, HHS. 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. Fed Regist. 2016;81:40890-40891.
    1. EMA. History of EMA. European Medicines Agency 2018. Available at: https://www.ema.europa.eu/en/about-us/history-ema. Accessed July 31, 2020.
    1. Comisión Federal para la Protección contra Riesgos Sanitarios. NotiReporta. https://notireporta-cofepris.mx/. Accessed May 29, 2019.
    1. 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.
    1. Food and Drug Administration. Adverse Events Reporting System (FAERS) Public Dashboard. https://fis.fda.gov/sense/app/d10be6bb-494e-4cd2-82e4-0135608ddc13/sheet.... Accessed June 26, 2020.

LinkOut - more resources