The Ministry of Health “MOH” through the Iraq Drug Regulatory Authority “IDRA” controls marketing authorization, pricing oversight, pharmacovigilance, inspections, import permissions, and promotion rules. Quality and standards interact with Central Organization for Standardization and Quality Control “COSQC” (under the Ministry of Planning), while localization incentives are influenced by the Ministry of Industry & Minerals.
Regulatory essentials.
All medicines (including biologics/biosimilars), medical devices, and most OTC products require IDRA approval based on safety, efficacy, and quality with evidence of GMP (and GCP for trials where applicable). Marketing authorizations are typically time-limited (commonly 5 years) and renewable with updated data. Generics follow an abbreviated, bioequivalence-driven route; biologics and biosimilars require comparability packages. Promotion is tightly controlled (no DTC for medicines), with strict rules on HCP interactions. Cannabis-based products are not authorized; opioids are authorized for medical use under strict controls.
Pricing, reimbursement, and access
Pricing is supervised by MoH/IDRA to balance access and affordability. Reimbursement is predominantly public, supplemented by private insurance in the private sector. Public procurement and tendering are pivotal for volume; distribution runs through licensed importers, wholesalers, hospitals, and pharmacies subject to GDP requirements.
Liability and IP
Product, tort, contract, and in some contexts strict liability apply. Claims can extend to individuals where direct involvement or negligence exists. Patents/trademarks are available subject to standard criteria; there is no dedicated orphan-drug pathway and no bespoke biosimilar statute (general rules apply).
Localization & industrial policy
While authorization remains science-based, broader industrial policy encourages local manufacturing and employment via tariffs, tax incentives, and potential preferences in tenders provided MoH quality requirements are met. Companies should evaluate whether local fill-finish, packaging, or technology transfer can improve pricing and tender competitiveness.
Market dynamics
Demand is driven by population growth, chronic disease burden, and rebuilding of health infrastructure. The public system anchors baseline access; private providers expand choice in urban areas. Supply chains are import-reliant but increasingly open to local production. Key frictions include regulatory variability in practice, tender predictability, customs/logistics, and FX/cash-flow management.
Risk & compliance posture
Expect routine inspections, PV reporting obligations, and strict controls on controlled substances, inducements, and advertising. Penalties range from fines and recalls to license suspension/revocation. Robust SOPs for GMP/GDP, PV, promotion, and distributor oversight are essential.