Skip to content
POL-75

This is a proposal for discussion, not an enacted law.

Ali Zuweid’s Political Programme

Proposed draft law · Health, Social Protection and Family

Food and Drug Authority, Medical Products Regulation and Food Safety

A unified legislative framework establishing a national regulator functionally independent of procurement and supply, responsible for the safety, efficacy and quality of medicines, vaccines and biological products; medical and diagnostic device regulation; food safety management; laboratory oversight; vigilance; recalls; digital traceability; and risk-based inspection.

Prepared by:

Document number
POL-75
Version
1.0
Publication date
5 October 2026
Scope
Republic of Iraq

Executive Summary

In September 2026, Iraq entered an active legislative process to establish a food and drug authority: the Council of Ministers approved the draft law following State Council review and referred it to the Council of Representatives. Its first reading was completed on 24 September 2026, and the Speaker directed that a workshop be held to refine it. This document offers a comprehensive legislative framework to inform that process, extending beyond creation of an administrative structure to expressly and coherently regulate the lifecycle of medicines, food and medical devices.

The proposal separates regulation from procurement and marketing and gradually transfers dispersed oversight functions to a specialised federal authority, while preserving the original roles of the Ministries of Health and Agriculture, Central Organization for Standardization and Quality Control, Border Ports Commission and local bodies within a clear distribution of responsibilities. It establishes a legal basis for registration and licensing; pre- and post-market oversight; pharmacovigilance and medical device vigilance; clinical trials; food safety; digital traceability; recalls; inspection; sanctions; and risk and emergency management.

The proposal preserves valuable existing assets, including the National Centre for Drug Control and Research and the national medicines system, ‘Kodia’, while moving them from fragmented arrangements into a unified legal system, guaranteeing continuity of registrations, licences and services and preventing market disruption during transition.

Legislative Gap

Principal Gaps Addressed by the Proposal
AreaCurrent positionProposed response
RegulatorResponsibilities dispersed across multiple units, ministries and authorities.A unified federal authority with legal personality and administrative, technical and financial independence, with precisely defined relations with other bodies.
Conflicting rolesPotential overlap between regulation, procurement, supply and service management.Prohibit the Authority from purchasing or trading in products it regulates and separate regulatory decisions from the government purchaser.
MedicinesMultiple rules and accumulated administrative practices, with challenges involving falsification, smuggling, registration and post-market oversight.A unified law on licensing, registration, manufacturing, import, distribution, pricing, vigilance, traceability and recalls.
Medical devicesExisting assessment and follow-up functions without a comprehensive risk-classification and device-lifecycle law.Risk classification, registration, local responsible persons, vigilance, maintenance, calibration, recalls and medical software.
Food safetyOversight dispersed across health, agriculture, standardisation, local bodies and border ports.A national authority managing food safety risks, with clear roles throughout the food chain.
LaboratoriesTesting centres with differing capabilities and inconsistent routes for recognising results.A network of reference and recognised laboratories, with quality systems, proficiency testing and phased accreditation.
TransparencyUneven public access to regulatory decisions and data.A public register of products, decisions, recalls, warnings and conflicts of interest.
Digital oversightProgress in medicine traceability through Kodia, with a need for legislative support and broader integration.Establish traceability in law and link it to customs, border ports, laboratories, inspection, pricing and vigilance.

Proposed Legislative Policy

  1. A unified regulator, not a purchaser: the Authority is established to regulate the market and protect public health; it does not purchase, import or trade in the products it regulates.
  2. Risk-based decisions: registration, testing and inspection intensity varies according to product and establishment risk and compliance history, rather than a uniform model that burdens low-risk products and wastes resources.
  3. Separate risk assessment from risk management: scientific committees and experts follow published standards and controlled conflict-of-interest arrangements, while regulatory decisions remain reasoned and open to review and appeal.
  4. Reliance on trusted reference bodies: controlled regulatory reliance on the World Health Organization and high-performing reference authorities is permitted without surrendering Iraq’s sovereign decision-making.
  5. Regulate the entire lifecycle: the Authority’s role continues beyond registration to manufacturing, distribution, storage, advertising, vigilance, traceability, recalls and post-market oversight.
  6. Integrated food safety: the Authority manages food risks to human health, while the Ministry of Agriculture retains animal and plant health and primary-production responsibilities, and the standardisation body retains standards and standardisation responsibilities under a binding coordination mechanism.
  7. Auditable digitalisation: Kodia, regulatory registers, traceability, inspection and recalls become part of a legal infrastructure that supports connectivity, verification and audit.
  8. Institutional transition without a vacuum: all registrations, licences and instructions remain effective until replaced, and functions, personnel and assets transfer gradually following an official inventory.

Draft Food and Drug Authority, Medical Products Regulation and Food Safety Law

In the name of the people

Presidency of the Republic

On the basis of the enactment by the Council of Representatives pursuant to Article (61), paragraph (First), and Article (73), paragraph (Third), of the Constitution, the following Law is enacted:

Statement of Reasons

To protect citizens’ health; unify and organise responsibilities for the safety, efficacy and quality of medicines, medical products and devices and food safety; separate regulation from procurement and supply; address fragmentation of registration, testing, inspection, vigilance and recalls across multiple bodies; develop laboratory oversight and digital traceability; combat adulterated and falsified products; and establish a national regulator operating on principles of science, risk, transparency and federal coordination, this Law is enacted.

Explanatory Memorandum

1. Why does Iraq need a law extending beyond creation of an authority?

A new authority without clear transfer of powers or definition of the product lifecycle could add a bureaucratic layer to existing ones. The proposal therefore directly links establishment to regulatory functions, prohibits procurement and trade, and provides institutional transition that removes rather than increases duplication. Citizens, investors, doctors, pharmacists, manufacturers and importers should know which body licenses, tests, monitors, recalls and holds parties accountable.

2. Separating regulator and purchaser

KIMADIA and government health institutions perform important procurement and supply functions, while Ministry of Health units handle registration, testing and oversight. Separating regulation from government procurement reduces institutional conflicts of interest and makes product acceptance or rejection a safety and quality decision rather than a supply decision. The proposal therefore prohibits the Authority from purchasing products it regulates, except samples and laboratory reference materials.

3. Building on existing capacity

The National Centre for Drug Control and Research, pharmacovigilance centre, registration and device departments and Kodia system are institutional and technical assets to transfer and develop rather than replace with parallel structures. The Law gives these functions a unified basis, preserves employee rights and prevents registration or testing from stopping during transfer.

4. Regulating medical devices separately from medicines

Devices are not medicines: their risk, performance, maintenance, software and vigilance requirements differ. A dedicated chapter therefore addresses device classification, conformity, local responsible persons, incident reporting, maintenance, calibration and medical software, consistent with modern World Health Organization and International Medical Device Regulators Forum approaches.

5. Food safety as a multisectoral system

Food safety cannot succeed by removing the roles of agriculture, standardisation or governorates, because risks begin in primary production and extend through manufacturing, transport and markets. The Authority therefore becomes a national risk manager for human health, while Agriculture retains animal and plant health and primary production, the standardisation body retains national standards, and local bodies retain delegated inspection under unified criteria. This reflects the need for multisectoral coordination in foodborne disease emphasised by Iraq’s programmes with the World Health Organization.

6. Regulatory reliance instead of repeating every assessment from scratch

Regulatory capacity does not require every national authority to repeat all tests and assessments undertaken by trusted global authorities. It requires knowing when to rely on them and when to request additional Iraqi data. The proposal therefore permits reliance on the World Health Organization and high-performing reference authorities while retaining Iraq’s final decision, helping accelerate access to essential medicines and reduce duplication without lowering protection.

7. Kodia as a legally established national system

Kodia has developed to trace medicines and verify authenticity, prices and batches, an important step against falsification and smuggling. The proposal turns traceability from an administrative project into a legal obligation linkable to customs, border ports, laboratories, inspection and vigilance, with scope for extension to other products when risks justify it.

8. Balancing safety and product availability

Excessive requirements may delay registration or cause shortages of medicines and devices; laxity opens the market to poor-quality or falsified products. The proposal therefore adopts risk proportionality, expedited pathways, conditional authorisation and regulatory reliance, while maintaining strict quality and post-market oversight.

Transitional Provisions and Implementation Requirements

Success depends on transition, not the text alone. The Authority must begin with a clear list of functions, assets and data to transfer and implement transfers in readiness-based stages. Transition may not interrupt medicine registration, shipment release or testing. Existing decisions and instructions continue until replacements are issued.

Proposed Transition Stages
PeriodPriorityRequired outcome
0–6 monthsForm the Board, complete institutional inventory and budget, transfer regulatory leadership and ensure service continuity.A legally established authority without market disruption.
6–12 monthsIntegrate pharmaceutical registration, vigilance, laboratory control, traceability and related inspection.A unified medicines regulatory window.
12–18 monthsActivate risk-based medical-device regulation and link import, traceability, maintenance and vigilance.An integrated national device system.
18–24 monthsComplete food safety, alert and coordination infrastructure with agriculture, standardisation and local bodies.Food oversight unified in health decisions and multisectoral in implementation.

Financial and Implementation Impact

Available public data do not permit a reliable establishment-cost figure without a detailed inventory of transferred personnel, assets, laboratories and systems. The proposal therefore avoids an artificial estimate, starting with reuse and transfer of existing resources rather than construction of a parallel apparatus.

The financial impact comprises four principal elements: transferring personnel and assets; developing electronic systems and linking them to border ports, customs and laboratories; strengthening reference laboratories, quality and accreditation; and expanding inspection, vigilance, device regulation and food safety. Potential savings arise from reducing duplicate testing and licensing, better targeting inspections, greater regulatory reliance and reduced circulation of falsified or non-compliant products. These savings should not be counted as certain amounts before a baseline and actual data exist.

The Law requires the transition committee to prepare a detailed transitional budget during the first budget-preparation cycle after commencement, identifying transferred appropriations and additional financing needs, clearly separating service fees from public revenues and preventing fees from incentivising more approvals.

Useful International Standards and Comparisons

The Law does not impose a single foreign model but draws on established international regulatory principles. The World Health Organization identifies good regulatory practice principles including legality, independence, impartiality, proportionality, transparency and efficiency. Its global tool assesses regulatory-system maturity across registration, vigilance, market surveillance, licensing, inspection, laboratories and clinical trials. The Organization has also developed a specific framework for assessing medical-device regulation.

For food safety, the proposal draws on Codex Alimentarius risk analysis, functional separation of risk assessment and management, hygiene principles and preventive-control systems. For medical devices, it uses the International Medical Device Regulators Forum’s essential safety and performance principles. Institutionally, regional experience, including Saudi Arabia and Jordan, demonstrates the value of placing food, medicines and devices under a clear regulator while retaining agriculture, standardisation and trade within a coordination network rather than every daily technical decision.

Sources and References

  1. Iraqi Council of Representatives — First Reading of the Draft Food and Drug Authority Law, 24 September 2026.Official source for the current legislative process and objective of unifying oversight bodies.
  2. Prime Minister’s Media Office — Approval of the Draft Food and Drug Authority Law and Referral to the Council of Representatives, 2 September 2026.
  3. Ministry of Health — Technical Affairs Directorate, National Centre for Drug Control and Research.Current functions in testing and assessing domestic and imported medicines and medical supplies.
  4. National Medicines System, ‘Kodia’.Medicine, price and batch traceability and verification, and prevention of falsification and smuggling.
  5. Ministry of Planning — Central Organization for Standardization and Quality Control.
  6. Public Health Law No. 89 of 1981, as amended.
  7. Pharmacy Practice Law No. 40 of 1970, as amended.
  8. Central Organization for Standardization and Quality Control Law No. 54 of 1979, as amended.
  9. World Health Organization — Iraq Results Profile 2024–2025.Includes strengthening national regulatory capacity for health products.
  10. World Health Organization — Universal Health Coverage Partnership, Iraq.Includes updating the national pharmaceutical profile and assessing the system using the WHO Global Benchmarking Tool.
  11. WHO — Good Regulatory Practices in the Regulation of Medical Products, TRS 1033, Annex 11.
  12. WHO — Global Benchmarking Tool for National Regulatory Systems.
  13. WHO — Global Benchmarking Tool Plus Medical Devices, 2024.
  14. WHO Iraq — Strengthening Foodborne-Disease Surveillance and Response, 2025.
  15. Codex Alimentarius — General Principles of Food Hygiene, CXC 1-1969, edition 2023.
  16. IMDRF — Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices, 2024.
  17. Pharmaceutical regulations in Iraq: from medicine approval to postmarketing.A review based on the Iraqi pharmaceutical profile prepared jointly by the Ministry of Health and World Health Organization.

Related Legislative Files

This proposal is thematically related to files on the national health system, health insurance, patient rights and healthcare quality and safety, mental health, and drug prevention, treatment and rehabilitation, as well as competition, consumer protection, intellectual property, data and cybersecurity laws when their publication within the programme is complete.

What are you looking for?

Search content published on the website.