The FDISM Department structure oversees the inspection activities and safety monitoring of all food and medical products manufactured locally and imported into the country as well as their inspections at all major ports of entry to stop the entry of substandard and falsified products into Rwanda. In addition, FDISM also oversees the inspection and licensing of all foods and drugs handling premises and monitoring of illegal operators of foods and drugs outlet, substandard and counterfeit regulated products through regular supervision and post-marketing surveillance. It ensures stakeholders service providers and the public receive the right information on the regulated products. It also ensures the verification, monitoring and certification of food and drug promotion materials to ensure that misleading, biased and inaccurate information about regulated products is not disseminated.
The FDISM Department operates under three (3) Divisions:
Food and Drugs Inspection and Compliance division (FDIC)
The FDIC division is in charge of ensuring compliance with the laws and regulations that apply to the manufacture, wholesale/distribution and retail of regulated products that are on the Rwandan market.
The roles and responsibilities of the FDIC division are the following:
- To assess the applications for authorization of premises for regulated products.
- To conduct inspection to ensure that premises are meeting the standard requirement to operate.
- To ensure the quality, the safety and the efficacy of the regulated products from distributors, manufacturers, and retailers.
- To issue the operational licenses to the premises complying to the requirements.
- To suspend the licenses if any of the conditions under which it was granted is violated.
- To conduct Good Manufacturing Practice (GMP) inspections of premises used to manufacture regulated products.
- To conduct Good Distribution Practice (GDP) inspections for licensed wholesale and retail premises.
- To develop regulatory documents related to licensing and inspection activities.
Food and Drugs Import and Export Control division (FDIEC)
The FDIEC division is in charge of issuing import and export licenses following application reviews, port of entry Inspections and sampling.
The roles and responsibilities of the division are the following:
- To control the importation and exportation of all regulated products.
- To receive and evaluate applications for import and export licenses for regulated products.
- To conduct inspection of consignments of regulated products at ports of entry and exit to ensure that they comply with the regulatory requirements.
Pharmacovigilance & Food Safety Monitoring (PFSM)
The PFSM division is in charge of Pharmacovigilance, post-marketing surveillance, product information, clinical trial oversight and food safety surveillance.
The roles and responsibilities of the PFSM division are the following as per regulatory functions:
Pharmacovigilance and Post-marketing surveillance
- To develop, review and distribute adverse events reporting tools to all stakeholders.
- To engage and sensitize stakeholders on pharmacovigilance activities.
- To receive, analyze and investigate adverse reactions (ADR) and adverse events following Immunizations (AEFI).
- To conduct signal detection, analyze and recommend appropriate regulatory action(s).
- To collect and communicate relevant medicines safety information to all stakeholders.
- To liaise with WHO program for international drug monitoring and sharing information on adverse reactions.
- To receive and analyze Periodic Safety Update Reports/ Periodic Benefit Risk Evaluation Report (PSUR/PBRER), Risk Management Plans (RMP) from Marketing authorization holders.
- To conduct Pharmacovigilance inspections ensuring compliance to the good pharmacovigilance practices.
- To participate in national, regional and international pharmacovigilance expert working group where it seeks to harmonize vigilance systems and safety requirements in the region.
- To network with other regional and international regulatory bodies for acquiring, sharing, and exchanging the relevant information on medical products safety.
- To serve as the secretariat of the National Pharmacovigilance Advisory Committee (PAC)
- To receive, analyze and investigate about reports on suspected Substandard and/or Falsified (SF) products from the market.
- To sample the regulated products for quality control analysis.
- To recall or remove SF products from the market.
- To initiate actions addressing the source cause of SF products.
- To set strategies preventing SF products from entering the supply chain.
- To receive and analyze reports on food safety and food-borne diseases.
- To receive and analyze the application on promotion and advertisement of regulated products.
Clinical Trial Oversight
- To coordinate all activities related to the conduct of clinical trials.
- To develop guidance documents and engage stakeholders.
- To receive and reviewing clinical trial application and clinical trial amendments.
- To conduct Good Clinical Practices (GCP) inspection for the approved protocols.
- To maintain and update the clinical trial register.
- To suspend, stop or terminate the non-compliant clinical trials.
- To ensure rational advertisement of regulated products by vetting promotional materials so that the information is not misleading the audience.
- To regulate product labelling and promotion on the market.
- To provide information to prevent drug and substance abuse, and promote appropriate and safe use of regulated products.