Iran's drug registration system requires rigorous documentation and evaluation before any pharmaceutical product can enter the market. Only legal entities holding exclusive agency for the Product License Holder or Marketing Authorization Holder can apply for registration. The process demands extensive documentation including Certificate of Pharmaceutical Product endorsed by Iranian Embassy, Good Manufacturing Practice certificates, global registration status, and detailed dossiers preferably in Common Technical Document format. Each application undergoes thorough evaluation by IFDA, with preclinical and clinical trial data required for new drugs, ensuring that only safe and effective medicines reach Iranian patients.

Iran implements a robust quality assurance framework that monitors pharmaceutical products before and after market entry. The first batch of any new product must undergo testing in Ministry of Health laboratories before release, establishing a critical safety checkpoint. Post-marketing surveillance includes random sampling for ongoing quality verification, with authorities maintaining the power to withdraw products if safety concerns arise. This dual-phase approach ensures continuous monitoring throughout a product's lifecycle, from initial approval through market distribution.

The regulatory framework establishes strict requirements for both domestic manufacturing and international importation of pharmaceuticals. Manufacturing companies must obtain licenses from both the Ministry of Industry and the Ministry of Health, with each facility required to appoint a qualified pharmacist as responsible officer. All imported drugs must receive authorization from the Ministry of Health, with importers providing comprehensive documentation proving the product's registration and consumption in other countries. This dual oversight ensures that all pharmaceutical products, regardless of origin, meet Iran's exacting standards.

Iran's pharmaceutical regulations operate within a five-tier legal structure, ranging from constitutional principles to international agreements and standards. This hierarchical approach ensures consistency across all regulatory levels while maintaining flexibility to incorporate international best practices. The system includes specific provisions for special categories such as orphan drugs for rare diseases, biologicals, and controlled substances, demonstrating the framework's comprehensive scope and adaptability to diverse pharmaceutical needs.