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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:

    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): 

 

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.