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Article History

Accepted: 20 June 2023

First Online: 7 October 2023

Declarations

:

: No funding was received for the development of this project.

: GRR, is an employee of COFEPRIS and has coordinated the implementation of the systems in Mexico. SAL is an employee of the Uppsala Monitoring Centre where VigiFlow, VigiLyze, VigiBase and the PV methods are produced and maintained. His participation in this project was via personal time and resources and the opinions stated in this manuscript does not necessarily reflect the ones of the Uppsala Monitoring Centre. RCS is an employee of CONAHCYT-COFEPRIS. MJL is the Commissioner of the Evidence and Risk Management department of COFEPRIS. AES is the Federal Commissioner and head of COFEPRIS. JAV is the head of Mexico’s Health Secretariat. The authors have no conflicts of interest to declare.

: Not applicable

: Not applicable

: Not applicable

: The data used in this project comes from COFEPRIS’ national safety databases from 1995 until December 2022 and Mexican data extracted from VigiBase. All the analyses and graphs displayed were carried out with permission and in collaboration with COFEPRIS with anonymised aggregated data.

: Not applicable

: GRR and SAL made a significant contribution from the conception to write up, design of the manuscript and analysis of data. RCS contributed as reviewer /author of intellectual content of the document. MJL, AES and JAV contributed as reviewers. All authors have read and agreed to the publication of the manuscript.