Palestine

Pharmacovigilance in the State of Palestine is coordinated by the Ministry of Health through its General Directorate of Pharmacy. Within that structure, the Drug Information Department includes a pharmacovigilance section responsible for developing the programme, following adverse-reaction reports and complaints, and issuing measures intended to reduce medicine-related risks. The Drug Registration Department evaluates the safety, efficacy, and quality of products and may assess safety alerts or cancel registrations for unsafe medicines. Suspected adverse reactions can be documented using the Ministry’s official spontaneous adverse-drug-reaction reporting form. Publicly accessible pages do not clearly state blanket requirements for every marketing authorisation Holder (MAH) to appoint a resident QPPV, maintain a local PSMF, or follow a complete set of fixed ICSR and periodic-reporting timelines. Companies should therefore verify current obligations with the Directorate, maintain documented safety procedures and an accessible local contact, and promptly communicate serious or unexpected risks, recalls, and safety-related changes. Where the cited public sources do not expressly define periodic safety reporting, risk-management plan, signal management and audit and inspection arrangements, the MAH should confirm the current product-specific requirements with the competent authority and against the marketing-authorisation conditions. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.