How to register products in Iranian FDA?

The Role of the Iranian FDA in Regulating Key Products

The Iranian Food and Drug Administration (IFDA) is the main regulatory body responsible for ensuring the safety, quality, and efficacy of products that directly impact public health. The organization operates under the Ministry of Health and Medical Education and plays a critical role in overseeing a wide range of products, including food, beverages, pharmaceuticals, cosmetics, medical devices, and traditional remedies. Its primary mission is to protect public health by enforcing strict regulatory standards and ensuring that all products meet national and international guidelines.

Different Administrations of IFDA

The IFDA is structured into specialized departments, each focusing on a particular category of products. This division allows for precise and expert evaluation tailored to the unique requirements of each product type. Some of the key departments and their responsibilities include:

Department of Food and Beverage Products Affairs: Responsible for assessing and approving the safety and quality of food and drink items before they enter the market.
Department of Pharmaceuticals and Controlled Products Affairs: Regulates the importation, production, and distribution of medicines and other controlled substances, ensuring their compliance with medical standards.
Department of Cosmetic and Hygienic Products Affairs: Evaluates cosmetic and personal care products to ensure they are safe for consumer use and meet hygiene regulations.
Department of Medical device & equipment: Focuses on the approval and regulation of medical devices and equipment used in healthcare settings.
Department of Natural, Traditional, Supplementary Products, and Infant Formula Affairs: Regulates natural and traditional remedies, dietary supplements, and infant formula, ensuring these products are both effective and safe for consumption.
Department of Reference Laboratories: Supports all other departments with advanced testing and analysis to verify the safety and authenticity of products.

Each product, based on its category and intended use, is reviewed by the relevant department. During this process, the product undergoes rigorous testing and evaluation to ensure compliance with health and safety regulations. Only after passing these assessments does the IFDA issue the required licenses, such as permits for importation, manufacturing, or marketing.

This systematic approach ensures that all products available to the public are of the highest quality, free from harmful substances, and suitable for their intended purposes. By maintaining this strict regulatory framework, the IFDA plays a vital role in safeguarding the health and well-being of the Iranian population.

In the following, we will review each of the departments and their respective responsibilities separately.

Drug Registration in Iran

Department of Food and Beverage Products Affairs:

Executive Activities:
Evaluation of Organic Products, Pesticides, and Contaminants

Review of organic product claims and referral to relevant specialized groups or the Food and Drug Departments.
Issuance of import or production permits for household and hygiene insecticides.
Issuance of permits for the importation of fruit and vegetable disinfectants and drinking water products.
Determination of Maximum Residue Limits (MRLs) for pesticides in agricultural products.
Planning and implementation of monitoring for licensed organic products (both imported and locally produced).

Evaluation of Safety Management Systems, Inspections, and Rating

Development of requirements and checklists for evaluating prerequisite programs (PRPs), food safety management systems based on HACCP and ISO22000.
Determination of requirements, evaluation, and ranking of food and beverage production units, and implementation of incentive and deterrent measures based on the achieved ranking.
Evaluation and certification of food safety management and organic systems related to imported goods.
Review and certification of the qualifications of certification bodies.
Determination of requirements and checklists for evaluating Good Manufacturing Practices (GMP) in foreign food and beverage production units.
Planning and follow-up of international affairs related to food safety.
Training and development of auditors and lead auditors for food safety management systems.

Food Safety Risk Assessment

Identification of hazards from food products.
Estimation of population exposure to each risk (prioritizing high-consumption products).
Risk calculation and decision-making regarding the current situation.

Post Market Surveillance (PMS)

Planning and development of annual operational guidelines.
Determination of products for evaluation and control indicators.
Compilation and statistical analysis of results.
Presentation of PMS results reports.

Training and Raising Awareness, Knowledge, and Skills of Employees and Technical Personnel

Conducting specialized and technical training courses.
Sending experts to international training programs.
Organizing workshops for transferring new information and technologies.

Monitoring Operational Programs and Performance Evaluation of Food and Drug Departments Nationwide

Setting objectives, planning, and developing operational programs, evaluating control indicators, and providing progress reports.
Planning and establishing performance evaluation indicators for the management of food, beverage, cosmetic, and hygienic materials, and conducting annual evaluations through the performance evaluation system.
Holding advisory committees for supervisory areas and academic hubs.

T.T.A.C System for Tracking All Products from Source to Destination (Consumer)

Registration of IRC codes.
Monitoring of returned shipments.
Review and approval of technical personnel qualifications.
Designing and implementing food product import and consumption systems.

Department of Pharmaceuticals and Controlled Substances

This department consists of subdivisions including:

Registration and Licensing Department:
The Registration and Licensing Department is one of the subsidiary departments under the General Directorate of Pharmaceuticals and Controlled Substances. Its primary responsibility is to oversee the quality, safety, and efficacy of medicines through the review of manufacturing and importation dossiers and the issuance of the relevant licenses. The goal of this department is to register high-quality, safe, and effective medicines for patients.
Services and Missions
This department consists of three units:

Licensing Unit
Study and Review Unit
1. Bioequivalence Studies Unit

Licensing Unit
The Licensing Unit is responsible for the following tasks:

Issuing licenses for pharmaceutical company activities.
Issuing and renewing the preliminary approval for the construction of pharmaceutical manufacturing factories.
Issuing and modifying the licenses for establishing pharmaceutical factories
Determining the review process for dossiers of domestically produced and imported medicines.
Initial review of applications for the registration and importation of drugs and obtaining opinions from the Legal Commission.
Issuing, renewing, and modifying licenses for technical managers of manufacturing and import companies.
Issuing, renewing, and modifying the registration licenses for domestically produced medicines.
Issuing, renewing, and modifying the registration licenses for imported medicines.
Issuing, renewing, and modifying export licenses.
Reviewing the Certificate of Pharmaceutical Products (CPP) and Free Sale Certificate (FSC) for exported medicines.
Holding meetings of the Legal Commission for manufacturing and importation issues.
Reviewing company issues in the TTAC system regarding technical managers, CEOs, and final product registration licenses
Implementing changes to the technical manager’s and CEO’s profiles in the TTAC system

Study and Review Unit
The Study and Review Unit is responsible for the following tasks:

Reviewing the Common Technical Dossier (CTD) for domestically produced, exported, contract-manufactured, and imported medicines.
Reviewing the generic names of medicines and forming the naming committee.
Reviewing documentation for the renewal or modification of manufacturing or importation licenses for medicines.
Reviewing changes in formulation, manufacturing methods, sourcing, and similar aspects in the drug dossiers.

What country imports the most pharmaceutical drugs?

Bioequivalence Studies Unit
The Bioequivalence Studies Unit is responsible for the following tasks:

Reviewing in vitro study results
Evaluating in vivo study questionnaires
Reviewing bioequivalence study results (in vivo)
Forming the bioequivalence studies committee for medicines

This department plays a critical role in ensuring that medicines produced or imported into the country meet the necessary regulatory and safety standards, safeguarding public health.

Department of Medical Equipment
Given the direct relationship between prevention, diagnosis, treatment, and disease monitoring with medical, dental, and laboratory equipment, and its significant role in health and safeguarding the lives of patients and users, the General Directorate of Medical Equipment is responsible for supervising the production, supply, consumption, and usage of high-quality, safe, effective, authentic, accessible, and reasonably priced medical equipment and supplies. The department aims to protect the lives and property of patients, ensuring the delivery of medical products to the target community. The main services and responsibilities provided by this department are as follows:

Supervision and Evaluation
Responsible for overseeing and evaluating medical, dental, and laboratory equipment and granting permits for activities related to production, import, export, distribution, and supply. This includes preparing and suggesting regulations, drafts, laws, and amendments concerning the mentioned fields.
Planning and Performance Evaluation
Planning to assess and improve the performance of stakeholders in the medical equipment sector.
Issuance of Licenses and Activity Identification
Issuing licenses and activity identification cards for companies and stakeholders in the medical equipment field (manufacturers, exporters, importers, distributors, and professionals).
Monitoring Import and Clearance of Medical Equipment
This includes:
- Issuing or canceling permits for import and clearance
- Assessing the quality and pricing of products
- Registering and allocating unique codes for equipment and updating their identification information
- Determining criteria and factors for ranking
Monitoring Production and Export of Medical Equipment
This includes:
- Issuing manufacturing certificates for producers
- Issuing permits for exporters
- Providing annual plans and programs to facilitate exports in coordination with relevant organizations
- Identifying domestic production capabilities and determining priorities for production and communication with relevant bodies
- Planning to support local production to enhance quality in line with the country’s overarching policies
Price and Distribution Monitoring
This involves monitoring the pricing, distribution, usage, and maintenance of medical equipment, including:
- Planning for price assessment and market price control
- Regulating the market through short-term, medium-term, and long-term plans to prevent shortages or control prices
- Creating a competitive environment among suppliers to increase product diversity, improve quality, and reduce prices
- Inspecting and monitoring distribution networks to improve distribution systems
- Legally addressing violations in the medical equipment, dental, and laboratory sectors through legal and judicial channels
Monitoring and Evaluating Equipment Maintenance
This includes:
- Evaluating post-sale services of companies
- Organizing a database for stakeholders in the medical equipment sector (importers, manufacturers, exporters, distributors, and professionals)
Supervising Medical Equipment Departments in Medical Universities
Evaluating and overseeing the performance of medical equipment departments in universities of medical sciences across the country.
Networking and Information Exchange
Creating networks and facilitating information exchange between public and private sectors to develop and capitalize on business opportunities.

This department ensures that medical equipment and supplies are safe, effective, and available to meet the needs of healthcare providers and patients, while also maintaining a competitive, well-regulated market.

Department of Cosmetic and Hygienic Products Affairs

This department is responsible for the development, regulation, and oversight of cosmetics and hygiene products. Its duties and responsibilities are as follows:

Policy Making, Planning, and Supervision
- Formulating policies, planning, and overseeing the development of guidelines for monitoring the production, import, distribution, and export of cosmetics and hygienic products.
- Developing and planning executive guidelines for delegating non-sovereign tasks to the private sector to increase the private sectors participation in these activities.
Health and Safety of Products
- Planning, overseeing, and regulating measures to enhance the health and safety of cosmetic and hygienic products and their related services.
Advertising and Consumer Education
- Planning, overseeing, and regulating guidelines for advertising and public awareness campaigns aimed at promoting the healthy use of cosmetics and hygiene products.
Control of Production and Distribution
- Planning and supervising the development of criteria and regulations for the production, import, distribution, transportation, quality control testing, storage, and disposal of cosmetic and hygienic products.
Registration and Licensing of Products
- Planning and establishing the necessary guidelines for receiving and reviewing the health dossiers of cosmetics and hygienic products to register, import, or manufacture them.
Supervision of Institutions
- Planning and developing guidelines for overseeing the performance of institutions involved in the production of cosmetics and hygienic products.
Market Surveillance
- Planning and implementing guidelines for monitoring the health of the cosmetics and hygienic product market, including the clearance of raw materials for imported products.
Implementation of Regulatory Guidelines
- Planning and developing guidelines for supervising cosmetics and hygienic products to ensure compliance with health and safety standards.
Supervision of University Departments
- Monitoring and evaluating the performance of the Food and Drug Deputies in the medical universities of the country regarding the cosmetic and hygienic product sector.
Anti-Smuggling and Anti-Counterfeiting Efforts

Planning and supervising the development of practical solutions to combat the smuggling and counterfeiting of cosmetic and hygienic products.

Training Programs

Planning and overseeing training courses for technical managers working in cosmetics and hygiene product institutions.

Licensing and Certification

Planning, supervising, and establishing necessary guidelines for the evaluation and issuance of licenses for the establishment and operation of institutions involved in cosmetic and hygienic products.

Development of Approved Product Lists

Planning and supervising the development of various lists of approved and safe cosmetic and hygienic products.

This department plays a vital role in ensuring the availability of safe, effective, and properly regulated cosmetic and hygienic products, contributing to public health and consumer protection.

Department of Natural, Traditional, Nutritional Supplements, Metabolic Special Foods, and Infant Formula
This department is responsible for the planning, regulation, and oversight of these products to ensure their safety, quality, and efficacy. The responsibilities include:

Policy and Program Planning
- Planning, evaluating, developing, delivering, communicating, and implementing policies, strategies, programs, and objectives for natural, traditional, nutritional supplements, metabolic special foods, infant formula, and special foods.
Research and Safety Control
- Planning and strategizing research related to monitoring, quality control, safety, health, and enhancing the quality of natural, traditional, nutritional supplements, metabolic special foods, infant formula, and special foods.
Regulation of Standards and Guidelines
- Overseeing the development, implementation, and enforcement of guidelines, regulations, and standards for the production, import, export, control, testing, storage, transport, distribution, consumption, recall, destruction, establishment of production units, technical responsibility, pricing, and price capping of these products.
Supervision of Service Providers
- Setting, developing, and implementing standards and regulations for monitoring and controlling the activities and services of companies that provide these products (including distribution companies, pharmacies, etc.).
Evaluation of Facilities and Licensing
- Implementing and supervising the evaluation, issuance, renewal, correction, and temporary or permanent cancellation of licenses (with decisions from the technical committee) for the establishment of production facilities, export, storage, transport, distribution, and handling of these products.
Evaluation and Issuance of Product Registration
- Supervising the evaluation, issuance, renewal, correction, and temporary or permanent cancellation of licenses for manufacturing and product registration, whether domestic production or imports, and for the export of these products.
Technical Responsibility Oversight
- Overseeing the issuance, renewal, and correction of technical responsibility licenses for production and importation facilities involved in these product categories.
Quality Control and Monitoring
- Planning, implementing, monitoring, and controlling the quality of production, storage, distribution, consumption, and handling of these products (PMQC/PMS), whether produced domestically, exported, or imported.
Inspection and Auditing
- Planning and conducting inspections, audits, and visits to production, export, import, storage, transport, and distribution facilities for domestic and foreign products in this sector, ensuring compliance with good practices (GDP, GSP, GMP, GXP).
International Representation
- Representing the Islamic Republic of Iran in international forums related to the safety and health of these products, such as PIC/S, ICH, EMA, TGA, FDA, WHO, Codex Alimentarius, and similar organizations.
Labeling and Authenticity
- Regulating and overseeing the labeling of natural, traditional, nutritional supplements, metabolic special foods, infant formula, and special foods, ensuring the authenticity of labels and product information.
Data Analysis and Reporting
- Analyzing statistical data to prepare reports and plan for improving the safety and health of these products, ensuring continuous improvements and regulatory compliance.

This department is pivotal in ensuring the safety, quality, and efficacy of products that play a crucial role in health and nutrition, thereby safeguarding public health and consumer welfare.

Department of Reference Laboratories

Laboratory Activities for Food, Drug, Biological, Cosmetic, and Health Products Quality Assurance

Resource Provision and Quality Assurance for Laboratory Activities
- Securing resources and ensuring the quality of laboratory activities to maintain and enhance the safety of food, pharmaceutical, biological, cosmetic, and health products, as well as dietary supplements, natural products, medical supplies, and equipment.
Strengthening and Expanding Educational Activities
- Strengthening and developing educational programs to train skilled and efficient professionals in the laboratory and quality assurance fields.
Establishing an Accountability System for Improved Services
- Creating a responsive system to deliver better services and increase customer satisfaction, ensuring that laboratory outputs meet regulatory and quality standards.
Creating an Integrated Information Management Network
- Developing an integrated information management system across food and drug control laboratories nationwide, enhancing data management, transparency, and operational efficiency.
Policy for Outsourcing Control Activities to the Private Sector
- Setting policies for outsourcing control activities to the private sector and enhancing the performance of control laboratories at the national level, ensuring that private laboratories meet required standards.
Strengthening Reference Laboratories and Quality Assurance
- Enhancing the development and capacity of reference laboratories and food and drug departments, in line with international quality management systems, safety requirements, and standards, including ISO 17025 and WHO requirements.
Delegation of Authority to Food and Drug Departments Nationwide
- Expanding delegation of authority to regional food and drug departments across the country, empowering local authorities to manage and enforce quality control activities efficiently.
Performance Evaluation and Monitoring of Collaborating Laboratories
- Strengthening and developing systems for evaluating and monitoring the performance of collaborating, licensed, and production-oriented laboratories, ensuring compliance with safety and quality standards.
Expanding Laboratory Capacity for Scientific Output
- Enhancing laboratory capacities to increase scientific production, update quality control methods, and ensure that the methods remain effective, credible, and aligned with current industry practices.
Collaboration with International Scientific and Regulatory Bodies
- Engaging in constructive and effective collaboration with reputable regional and international scientific, regulatory, and research organizations to elevate the scientific and technical capabilities of laboratories, ensuring alignment with global standards and practices.

These activities aim to foster a robust and responsive laboratory system that is integral to ensuring the safety and quality of health-related products, benefiting public health while keeping pace with global advancements.

How to register products in Iranian FDA?

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