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.

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

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