In the realm of pharmaceutical regulatory affairs, staying abreast of updates and guidelines is crucial for companies seeking market approval for their medicinal products. The recent note issued by the Panama authority, Nota N° 098-DNFD-2024, clarifies some aspects of the Pharmacovigilance (PVG) procedures. Let's delve into the key takeaways encapsulated in this note to navigate the intricacies of PVG in Panama:
Clarification on PSUR Submission
One of the key points highlighted in the Panamanian authority's notice concerns the submission of Periodic Safety Update Reports (PSURs). According to the updated guidelines, companies may now submit a single PSUR per active substance. This update addresses the previous regulatory requirement to submit identical PSURs for each marketing authorization containing the same substance. It is important to note that in Panama, each unique strength and dosage form requires a separate marketing authorization, even when they share the same indications and trade names. Therefore, the submission must include a list of all products and marketing authorizations in the country that are associated with the PSUR. This change is expected to streamline the submission process and improve efficiency for pharmaceutical companies.
Guidelines for Designating Pharmacovigilance Contacts
The notice also provides supplementary guidelines regarding the procedures for notifying the designation of the "Responsable de Farmacovigilancia (RFV)" and the "Representante de Farmacovigilancia (RPFV)" for the country. These roles are similar to the Qualified Person for Pharmacovigilance (QPPV) and the local pharmacovigilance contact seen in Europe and other regions.
Leveraging the FADDI Platform for PVG-Related Submissions
The authority has provided clarification on how to confirm the receipt of pharmacovigilance-related submissions made to the Panamanian authority via the digital platform, Farmacia y Drogas Digital (FADDI). The notice explains how applicants can track and verify the receipt of their submissions using this online interface.
Panama is a Central American country where we are observing increased regulatory requirements and enforcement activities related to pharmacovigilance. Stay tuned for more insights and updates on pharmaceutical regulatory affairs to help navigate the evolving landscape of drug approval processes and pharmacovigilance standards.
A copy of the Panamanian regulatory authority's notice can be found below (in Spanish).
Keep abreast of regulatory updates for a compliant pharmacovigilance journey in Panama!
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