Panama embraces international pharmacovigilance standards

Home/Policies & Legislation | Posted 09/07/2024 post-comment0 Post your comment

Panama is implementing internationally standardized reporting codes for pharmacovigilance by adopting WHODrug Global and MedDRA dictionaries, following the example of several other Latin American and Caribbean countries.

Pharmacovigilance V13F21

In April 2024, through the National Directorate of Pharmacy and Drugs (DNFD) of the Ministry of Health, Panama presented the functionalities of the updated regional pharmacovigilance system to health professionals interested in adopting international standards and linked to pharmacovigilance units of the pharmaceutical industry.

This is the implementation of the operational functionalities of the WHODrug Global and MedDRA (Medical Dictionary for Regulatory Activities) dictionaries, which allow member countries to access the Regional System for Suspected Adverse Reactions to Human Drugs and Vaccines online in real time. Argentina, Brazil, Colombia, Ecuador, Mexico, Peru, and Uruguay have all adopted the WHODrug Global and MedDRA dictionaries. The exchange of information through this system is already in use in 112 countries around the world.

This action aims to strengthen national and regional pharmacovigilance activities, in parallel with extending the current regulations in Panama, as outlined in the updated Law 419/2024. This law, enacted by the President of Panama on 1 February 2024, was created to guarantee the supply of medicines through centralised purchasing. It also sanctions companies that fail to deliver medicines, guided by a novel pharmacovigilance framework.

On 18 January 2024, the National Assembly (AN-Panamanian Parliament) approved Bill 1007, a new law that regulates medicines, supplies, devices, and other products for human health, their public acquisition, and other provisions [1].

Parallel to this, Mexico’s Federal Commission for the Protection Against Health Risks (COFEPRIS) is enhancing their pharmacovigilance reporting system by updating the use of WHODrug and MedDRA, which it adopted in 2018. They recently announced on 24 April 2024 the timeline for companies to align their products and licensing documents with these updated terms.

Related articles
Differences in immunogenicity, pharmacovigilance and legal documents in biological products in Latin America

Differences in clinical studies and pharmacovigilance of biological drugs in Latin America

The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.

View the latest headline article: La FDA aprueba el primer biosimilar de eculizumab, Bkemv, para dos enfermedades raras

Browse the news in the Latin American Forum!

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.

Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.

Ver el último artículo de cabecera: La FDA aprueba el primer biosimilar de eculizumab, Bkemv, para dos enfermedades raras

!Explore las noticias en el Foro Latinoamericano!

Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa. 


1. GaBI Online - Generics and Biosimilars Initiative. Panama enacts new bill to guarantees the supply of medicines []. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jul 9]. Available from:

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2024 Pro Pharma Communications International. All Rights Reserved.

comment icon Comments (0)
Post your comment
Related content
FDA proposal to remove biosimilar interchangeability status in FY25
01 AA007239
Home/Policies & Legislation Posted 12/06/2024
MHRA unveils strategy for regulating AI technologies
23 AA011020
Home/Policies & Legislation Posted 22/05/2024
Regulatory Certainty Strategy for biosimilars launched in Mexico
Home/Policies & Legislation Posted 09/04/2024
Strategic plans of ANVISA and COFEPRIS to advance health regulation
11 AA010165
Home/Policies & Legislation Posted 11/03/2024
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010