Office of the Deputy Director General is responsible for: 

1. Deputizing the Director General in his or her absence;

2. Assisting the Director General (DG) in the implementation of the National Strategy for the Development programs and activities

3. leading, directing and coordinating the functions of core departments ad divisions as laid down in Rwanda FDA laws

4. Coordinating the preparation and ensuring the execution of annual action plans (strategic, activities, financial, procurement and audit) and quarterly reports (activities, financial, procurement and audit) of Rwanda FDA.

These roles and responsibilities are implemented through the following divisions and departments: 

1. Regulatory Ecosystem Strategy Division

2. Food Department

3. Drugs Department

4. Laboratory Services Department

Regulatory Ecosystem Strategy Division

Rwanda FDA aspires to play a proactive and strategic role within the evolving national, regional, and global health regulatory ecosystem. The Regulatory Ecosystem Strategy Division supports this vision by guiding institutional strategy, innovation, and regulatory foresight.

The Division is responsible for:

1. advising on long-term regulatory strategies that enable Rwanda FDA to respond effectively to emerging technologies, rapidly evolving pharmaceutical markets, and changing public health priorities; 

2. Contributing to the identification of opportunities for regulatory innovation, digital transformation, reliance mechanisms, and performance optimization;

3.  Conducting regulatory intelligence, and policy analysis to ensure alignment with applicable standards, and regional and international harmonization initiatives;

4.  supporting strategic planning processes and monitoring the implementation of institutional transformation initiatives;

5. Strengthening Rwanda FDA’s positioning as a credible, responsive, and forward-looking National Regulatory Authority, through collaboration with national institutions, regional regulatory networks, and international partners. 

Food Department

The Food Department is responsible for:

1. Protecting and promoting public health through market authorization, food safety monitoring and import and export control of:

   Food products:

• Processed food products;

• Fortified food products;

• Food supplements;

• Food additives; 

• Food fortificants; 

• Breast milk substitutes and complementary foods;

• Therapeutic and medical foods;

• Genetically modified food

Raw and packaging materials:

• Raw materials including active and inactive, used in the manufacture or processing of products regulated under the scope of Food Department;

• Packaging materials used for products regulated under the scope of Food Department;

1. Ensuring the establishment, maintenance, and regular updating of official registers of registered food products and licensed premises or other regulatory approvals in accordance with applicable laws and regulations;

2. Supporting post-authorization regulatory functions, including food safety monitoring and regulatory decision-making throughout the product lifecycle.

3. Ensuring evidence-based, transparent, and consistent regulatory decisions through close collaboration with other offices/departments/divisions/units including the Laboratory Services Department and Quality Management System (QMS) Division among others.

These roles and responsibilities are implemented through the following Divisions within the Food Department:

1. Food Registration and Information Control Division

2. Food Safety Monitoring, Inspection and Licensing Division

3. Food Imports and Exports Control Division

Food Registration and Information Control Division

Food Registration and Information Control Division is responsible for:

1. Conducting scientific evaluation of submitted products’ dossiers to assess quality, safety, and efficacy of the below food products prior to the granting of Marketing Authorization (MA): 

• Processed food products;

• Fortified food products;

• Food supplements;

• Food additives; 

• Food fortificants; 

• Breast milk substitutes and complementary foods;

• Therapeutic and medical foods;

• Genetically modified food

1. Coordinating with relevant technical divisions and committees to facilitate the scientific assessment and regulatory decision-making process for market authorization applications.

2. Assessing applications for variations, renewals, and other post-market authorization amendments to registered food products and making recommendations for regulatory action.

3. Maintaining accurate and up-to-date records of food products granted Marketing Authorization and ensuring the integrity of the official food product register.

4. Establishing and publishing a list of prohibited substances and products. 

   Food Safety Monitoring, Inspection and Licensing Division

The Food Safety Monitoring, Inspection and Licensing Division is responsible for:

1. Registering and licensing food establishments in accordance with applicable legal and regulatory requirements.

2. Conducting inspections of food establishments to assess compliance with food safety requirements, Good Manufacturing Practices (GMP), and other applicable standards.

3. Implementing post-market surveillance activities to monitor the safety, quality, and compliance of food products placed on the market in accordance with applicable legal and regulatory requirements and/or standards.

4. Maintaining and updating regulatory records, registers, and databases relating to licensed food establishments, inspection outcomes, compliance status, and enforcement actions.

 Food Import and Export Control Division 

The Food Import and Export Control Division is responsible for:

1. Receiving, evaluating, and processing applications for import and export authorizations for regulated food products under the scope of Food Department in accordance with applicable legal and regulatory requirements. 

   1. Conducting inspections of consignments at points of entry and exit to verify compliance with applicable legal and regulatory requirements

   2. Collaborating with customs and other competent authorities to strengthen border control and facilitate the effective regulation of imported and exported regulated food products under the scope of Food Department. 

   3. Implement appropriate regulatory actions in cases of non-compliance, including detention, rejection, or seizure of consignments, to ensure that only safe, quality-assured, and authorized food products enter or leave the country.

Drugs Department 

    The Drugs Department is responsible for:

1. protecting and promoting public health through market authorization, clinical trial oversight, vigilance and import and export control of:

   1. Pharmaceutical and other health products

      • human and veterinary medicines and vaccines; 

      • narcotics and psychotropic drugs, and other controlled substances; 

      • blood and blood products; 

      • biopharmaceutical products; 

      • radiopharmaceutical products; 

      • nanotechnology-based drugs and therapies; 

      • advanced therapies including gene-therapies,

      • cell-based products and regenerative medicines; 

      • other human and veterinary biological products used as medicines;

      • Clinical trial investigational products regulated under the scope of this Order;

      • Herbal medicines;

      • Tobacco and nicotine products;

      • Cosmetic products;

      • Antiseptic products for healthcare use;

      • Laboratory reagents used for public health and veterinary purposes;

Machinery, medical equipment and devices:

• Human and veterinary medical devices 

  • in-vitro diagnostics;

    •  Medical equipment;

    • Ionizing radiation emitting medical equipment and devices;

    • Artificial intelligence-enabled diagnostic and therapeutic devices;

    • Equipment and machineries intended for manufacturing of products regulated under Drugs department.

Raw and packaging materials:

• Raw materials including active and inactive, used in the manufacture or processing of products regulated under Drugs department;

  • Packaging materials used for products regulated under Drugs department.

1. Ensuring the establishment, maintenance, and regular updating of official registers of registered products and licensed premises or other regulatory approvals in accordance with applicable laws and regulations;

2. Supporting post-authorization regulatory functions, including vigilance, post-market surveillance, and regulatory decision-making throughout the product lifecycle.

3. Ensuring evidence-based, transparent, and consistent regulatory decisions through close collaboration with other offices/departments/divisions/units including the Laboratory Services Department and Quality Management System (QMS) Division among others.

These roles and responsibilities are implemented through the following Divisions within the Drugs Department:

1. Human Medicines and Medical Devices Registration Division

2. Veterinary Medicines and Devices Registration Division

3. Pharmacovigilance and Clinical Trials Division

4. Pharmaceutical Inspections and Licensing Division

5. Cosmetics & Household Chemicals Registration

6. Drugs Imports and Exports Control Division

Human Medicine and Devices Registration Division 

The Human Medicines and Diagnostics Registration Division is responsible for:

1. Conducting scientific evaluation of submitted products’ dossiers to assess quality, safety, and efficacy of the below products prior to the granting of Marketing Authorization (MA): 

i. Pharmaceutical and other health products

• human medicines and vaccines ; 

  • narcotics and psychotropic drugs, and other controlled substances; 

    • blood and blood products; 

    • biopharmaceutical products; 

    • radiopharmaceutical products; 

    • nanotechnology-based drugs and therapies; 

    • advanced therapies including gene-therapies, 

    • cell-based products and regenerative medicines; 

    • other human and biological products used as medicines;

    • Clinical trial investigational products regulated under the scope of this Order;

    • Herbal medicines;

    • Tobacco and nicotine products;

Machinery, medical equipment and devices:

• Human medical devices 

  • in-vitro diagnostics;

    •  Medical equipment;

    • Ionizing radiation emitting medical equipment and devices;

    • Artificial intelligence-enabled diagnostic and therapeutic devices;

1. Coordinating with relevant technical divisions and committees to facilitate the scientific assessment and regulatory decision-making process for market authorization applications.

2. Assessing applications for variations, renewals, and other post-market authorization amendments to registered products and making recommendations for regulatory action.

3. Maintaining accurate and up-to-date records of products granted Marketing Authorization and ensuring the integrity of the official product register.

4. Establishing and publishing a list of prohibited substances and products. 

Veterinary Medicine and Devices Registration Division 

The Veterinary Medicines and Devices Registration Division is responsible for:

1. Conducting scientific evaluation of submitted products’ dossiers to assess quality, safety, and efficacy of the below products prior to the granting of Marketing Authorization (MA): 

   1. Veterinary medicines 

   2. Veterinary biological products

   3. Veterinary medical devices including in-vitro diagnostics;

2. Coordinating with relevant technical divisions and committees to facilitate the scientific assessment and regulatory decision-making process for market authorization applications.

3. Assessing applications for variations, renewals, and other post-market authorization amendments to registered products and making recommendations for regulatory action.

4. Maintaining accurate and up-to-date records of products granted Marketing Authorization and ensuring the integrity of the official product register.

5. Establishing and publishing a list of prohibited substances and products. 

Cosmetics and Household Chemicals Registration Division

The Chemicals, Household Products and Cosmetics Registration Division is responsible for:

1. Conducting scientific evaluation of submitted products’ dossiers to assess quality, safety, and efficacy of the below products prior to the granting of Marketing Authorization (MA): 

   1. Cosmetic products;

      1. Antiseptic products for healthcare use;

      2. Household chemicals 

      3. Laboratory reagents used for public health and veterinary purposes. 

2. Coordinating with relevant technical divisions and committees to facilitate the scientific assessment and regulatory decision-making process for market authorization applications.

3. Assessing applications for variations, renewals, and other post-market authorization amendments to registered products and making recommendations for regulatory action.

4. Maintaining accurate and up-to-date records of products granted Marketing Authorization and ensuring the integrity of the official product register.

5. Establishing and publishing a list of prohibited substances and products. 

Pharmaceutical Inspection and Licensing Division

The Pharmaceutical Inspection and Licensing Division is responsible for:

1. Conducting inspections of pharmaceutical establishments to verify compliance with applicable laws, regulations, Good Practice (GxP) standards and Quality Management System (QMS). 

2. Conducting Good Clinical Practice (GCP) inspections to verify compliance with approved protocols, regulatory requirements, and international standards. 

3. Assessing the suitability and operational readiness of regulated premises, including infrastructure, equipment, utilities, sanitation, hygiene, and personnel, to ensure compliance with regulatory requirements. 

4. Granting, renewing, suspending, or revoking licenses and issued GxP certificates and certificates of compliance to quality audits for pharmaceutical establishments based on inspection findings and compliance status. 

5. Providing regulatory guidance and technical recommendations to facilitate corrective and preventive actions (CAPA) and promote sustained regulatory compliance. 

6. Collaborating with national, regional, and international regulatory authorities to strengthen regulatory harmonization, information exchange, and adoption of best regulatory practices.

   Drugs Import and Export Control Division

The Drugs Import and Export Control Division is responsible for:

1. Receiving, evaluating, and processing applications for import and export authorizations for regulated products under the scope of Drugs Department in accordance with applicable legal and regulatory requirements. 

2. Conducting inspections of consignments at points of entry and exit to verify compliance with applicable legal and regulatory requirements

3. Collaborating with customs and other competent authorities to strengthen border control and facilitate the effective regulation of imported and exported regulated products under the scope of Drugs Department. 

4. Implement appropriate regulatory actions in cases of non-compliance, including detention, rejection, or seizure of consignments, to ensure that only safe, quality-assured, and authorized products enter or leave the country.

   Pharmacovigilance and Clinical Trials Division

The Pharmacovigilance and Clinical Trials Division is responsible for:

1. Monitoring the safety, quality, and performance of regulated products by receiving, assessing, investigating, and managing adverse events (AEs), adverse events following immunization (AEFI), and reports of suspected substandard and falsified (SF) products throughout their lifecycle considering the scope of regulated products under Drugs Department.

2. Conducting signal detection and management, and reviewing Periodic Safety Update Reports (PSURs/PBRERs) and Risk Management Plans (RMPs), and recommending appropriate regulatory actions. 

3. Conducting Good Pharmacovigilance Practice (GVP) inspections to verify compliance with applicable regulatory requirements and monitoring the implementation of corrective and preventive actions (CAPA) from GVP inspections findings. 

4. Coordinating and overseeing regulatory actions relating to safety and quality concerns, including product recalls, recall audit activities, withdrawals, , risk minimization measures, and collaboration with relevant divisions on enforcement actions. 

5. Reviewing and evaluating clinical trial applications and amendments, overseeing the conduct of approved clinical trials, maintaining the national clinical trial register, and taking appropriate regulatory actions for non-compliant clinical trials in accordance with applicable legal, regulatory and ethical requirements.

6. Regulating and analysing product information used in labeling, promotion, advertising and marketing of products regulated under the scope of Drugs Department by reviewing and approving promotional materials and ensuring compliance with applicable legal and regulatory requirements. 

7. Promoting the safe, appropriate, and rational use of regulated products through medicines safety communications, public awareness initiatives, and measures to prevent drug and substance abuse. 

8. Develop regulatory guidance, standards, and reporting systems, and strengthen pharmacovigilance, post-marketing surveillance, clinical trial oversight, and product information systems through stakeholder engagement and capacity building. 

9. Coordinate national vigilance systems and collaborate with national, regional, and international partners, including WHO, the Uppsala Monitoring Centre (UMC), and other regulatory authorities, to strengthen information sharing, regulatory harmonization, and adoption of international best practices.

Laboratory Services Department

The Laboratory Services Department is the technical department of Rwanda FDA responsible for providing independent, reliable, and scientifically sound laboratory services to support the regulation of regulated products. The Department conducts quality control testing, laboratory investigations, and lot release activities using internationally recognized standards and validated analytical methods. Through the implementation of a robust Quality Management System in accordance with ISO/IEC 17025 and other applicable regulatory requirements, the Department generates credible scientific evidence that supports regulatory decision-making, safeguards public health, and promotes confidence in products placed on the market.

These roles and responsibilities are implemented through the following Divisions and Units within the Laboratory Services Department:

1. Drugs Testing Division

2. Vaccines and Biologics Testing Division
3. Food Testing Unit
4. Microbiology Unit
5. Pesticides, Poisonous Substances and Chemical Testing Unit
6. Medical Devices and Instrumentation Testing Unit

Drugs Testing Division

The Drug Testing Division is responsible for:

1. Conducting physicochemical testing of medicines and cosmetics to determine compliance with approved quality standards.

2. Developing, verifying, validating and implementing analytical methods and standard testing procedures.

3. Ensuring the integrity, confidentiality and timely reporting of laboratory test results.

4. Implementing and maintaining the laboratory Quality Management System in compliance with ISO/IEC 17025 and applicable regulatory requirements.

5. Supporting regulatory decision-making through scientific testing, technical advice and laboratory investigations.

Vaccines and Biologics Testing Division

Vaccines and Biologics Testing Division is responsible for:

1. Conducting quality control testing and lot release of vaccines and biological products.

2. Reviewing manufacturers' lot documentation and perform technical assessment for regulatory release.

3. Developing, validating and implementing analytical methods and standard testing procedures for biological products.

4. Ensuring compliance with laboratory quality management requirements and international standards.

5. Providing scientific evidence to support regulatory decisions on vaccines and biological products.

Food Testing Unit

 The Food Testing Unit is responsible for:

1. Conducting chemical and physical testing of processed foods and food supplements for compliance with established standards.

2. Developing, verifying and implementing validated analytical methods and standard testing procedures.

3. Ensuring accurate, reliable and timely reporting of laboratory test results.

4. Participating in laboratory quality assurance activities, including proficiency testing and equipment qualification.

5. Supporting food safety regulatory decisions through scientific laboratory analysis.

Microbiology Unit

The Microbiology Unit is responsible for:

1. Performing microbiological testing of regulated products, environmental samples and related materials.

2. Detecting microbial contamination and evaluate compliance with microbiological quality standards.

3. Developing, validating and implementing microbiological test methods and standard procedures.

4. Maintaining microbiological quality assurance, biosafety and data integrity requirements.

5. Providing microbiological evidence to support regulatory actions and public health protection.

Pesticides, Poisonous Substances and Chemical Testing Unit

The Pesticides, Poisonous Substances and Chemical Testing unit is responsible for:

1. Conducting quality and safety testing of pesticides, household chemicals, poisonous substances and other regulated chemicals.

2. Developing and implementing validated analytical methods and standard testing procedures.

3. Ensuring accurate, reliable and timely laboratory reporting to support regulatory decisions.

4. Maintaining compliance with laboratory quality management, equipment calibration and proficiency testing requirements.

5. Providing technical expertise on the quality, safety and compliance of regulated chemical products.

Medical Devices and Instrumentation Testing Unit

 The Medical Devices and Instrumentation Testing Unit is responsible for:

1. Conducting laboratory testing of medical devices including in vitro diagnostics and related products against applicable technical standards.

2. Developing, verifying and implementing testing methods and standard testing procedures for medical devices.

3. Ensuring the accuracy, reliability and traceability of testing results.

4. Maintaining laboratory quality management practices, equipment qualification and technical competence.

5. Providing scientific evidence to support regulatory evaluation, conformity assessment and market surveillance of medical devices.