Maldives

Pharmacovigilance in the Maldives is coordinated by the Maldives Food and Drug Authority (MFDA) through its Pharmacovigilance Unit within the Medicine and Therapeutic Goods Division (MTG). The current Guideline on Pharmacovigilance and ADR Reporting, Version 2, issued 4 March 2026 requires Marketing Authorisation Holders (MAHs) to maintain a pharmacovigilance system, report ADRs and safety concerns to MFDA in a timely manner, appoint a Qualified Person for Pharmacovigilance (QPPV), conduct risk management and post-marketing safety studies where required, and implement corrective actions based on safety updates. The guideline also requires MAHs to submit a company Risk Management Plan (RMP) at the commencement of each calendar year no later than January and to submit annual data on activities undertaken under the RMP electronically to the MTG vigilance address. The 24–48-hour reporting period for serious cases and the one-week period for non-serious cases apply specifically to healthcare professionals and patients. MAHs are instead instructed to report ADRs associated with their registered products in accordance with the product-registration guideline; these periods should therefore not be presented as general MAH reporting timelines. The current guideline does not establish a universal PSMF format or a QPPV residency rule in the cited public text. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.