Food and Drugs Assessment and Registration

The FDAR Department protects and promotes human and veterinary public health through conducting assessment and evaluations of application dossiers for processed foods/ drinks, food additives, food supplements, both human and veterinary medicines, vaccines and other biologics, medicated cosmetics, medical devices, chemicals and pesticides, and tobacco and tobacco products. The FDAR Department also recommends for registration and/or marketing authorization (MA) to products that comply with Rwanda FDA regulatory requirements for registration.

The FDAR Department operates under four (4) Divisions:

Human Medicine and Devices Assessment and Registration (HMDAR)  Division

The HMDAR  Division is in charge of ensuring that all Human Medicines and Devices dossiers received are recorded, screened, and scientifically and timely evaluated for quality, safety and efficacy before they are registered or granted Marketing Authorization to be placed on the Rwandan market through implementation of various provisions of the law, regulations and guidelines related to medical products assessment and registration enforced by the Rwanda FDA.

The roles and responsibilities of the  HMDAR Division are the following:

  1. To assess Human medicines, herbal medicines,  vaccines and biosimilar, radio pharmaceuticals and radiotherapy products, diagnostics, and medical devices.
  2. To participate in the development and revision of regulations, guidelines, manuals and  standard operating procedures (SOPs) related to the assessment and registration of human medicines and  devices.
  3. To actively collaborate with other divisions for better conduct of assessment and registration. These includes the Quality Control Laboratory Division and Inspection and Compliance Division which facilitate the registration process through sample testing and Good Manufacturing Practices (GMP).

Veterinary Medicine and Devices Assessment and Registration (VMDAR) Division

The VMDAR Division is in charge of ensuring that all Veterinary Medicines and Devices are correctly and timely evaluated for quality, safety and efficacy before registration as authorized products for marketing in Rwanda.

The roles and responsibilities of the VMDAR Division are the following:

  1. To ensure that registers of approved variations, new products, suspensions, and deletions are timely updated.
  2. To ensure the development and the review of regulations, guidelines, manuals, and standard operating procedures (SOPs) related to the assessment and registration of Veterinary Medicines and Devices.
  3. To actively collaborate with other divisions for better conduct of assessment and registration. These include the Quality Control Laboratory Division and the Inspection and Compliance Division which facilitate the registration process through sample testing and Good Manufacturing Practices (GMP).

Cosmetics and Household Chemicals Assessment and Registration (CHCAR) Division

The CHCAR Division  is responsible for protecting and promoting human public health by ensuring that:

  • Medicated cosmetics,
  • Public health laboratory chemicals
  • Household pesticides, 
  • Antiseptic and disinfectants,
  • Cleaning chemicals,

are registered and approved for use in Rwanda by being granted a Marketing Authorization before being placed on the Rwandan market. CHCAR division ensures that the above products are safe and effective for their intended use and that they meet established quality standards.

The roles and responsibilities of the CHCAR Division are the following:

  1. To assess all medicated cosmetics, household chemicals, cleaning chemicals and pesticides, Antiseptic and disinfectants products dossiers requesting for marketing authorization.
  2. To participate in the development of regulations and guidelines and standard operating procedures (SOPs) related to the assessment and registration of medicated cosmetics, household chemicals, cleaning chemicals and pesticides,
  3. To actively collaborate with other divisions for better conduct of assessment and registration. These includes the Quality Control Laboratory Division and Inspection and Compliance Division which facilitate the registration process through Sample testing and Good Manufacturing practices (GMP).

Food Assessment and Registration (FAR) Division

The FAR Division is in charge of handling dossiers requesting for food products registration through conducting  assessment and registration of food products to ensure their safety and quality prior to market authorization.

The roles and responsibilities of the  FAR Division are the following:

  1. To facilitate the issuance, renewal or cancellation of food products marketing authorizations.
  2. To participate in the development  of regulations, guidelines and standard operating procedures (SOPs) related to food and food safety management system.
  3. To manage the resources and business operations of the Division.