Rwanda Food and Drugs Authority is the national regulatory authority of pharmaceutical industry in Rwanda. The mandate of the Authority is to protect public health through regulation of human and veterinary medicines, vaccines and other biological products, processed foods, poisons, medicated cosmetics, medical devices, household chemical substances, tobacco and tobacco products.
This is achieved through assessment and registration; inspection and licensing; control of imports and exports; pharmacovigilance; post-marketing surveillance; clinical trials; control of promotion and advertisements; laboratory testing; and enforcement. Rwanda FDA commits adequate financial, human, physical and technological resources for implementing, maintaining and continually improving the quality of its management system to achieve set objectives; and maintain an adequate workforce that is trained, motivated, facilitated and empowered to achieve results. Quality objectives, processes, systems and procedures that support this quality policy are established and reviewed periodically for continuing suitability.

An application for product registration for either locally manufactured or imported products is made in writing via a cover letter and application form dated and signed by the applicant. If the application is a foreign company, the applicant appoints a local technical representative to submit the application. The local agent should be a registered wholesale company or an accredited manufacturer’s representative. All applications are to be submitted to the Rwanda FDA through the authorized local technical representative.

The import and export of Rwanda FDA regulated products is done in accordance with import and Export regulations, procedures and requirements for the importation and export of regulated products. The application for import permit is done online through PRIMS for registered and licensed premises. Only Rwanda FDA registered regulated products are allowed to be imported and marketed in Rwanda.

FDA is the regulatory authority in Rwanda mandated to regulate, approve and inspect the conduct of clinical trials. Investigators and Sponsors are required to submit their applications for approval to conduct trials in Rwanda. Good Clinical Practice (GCP) principles and other ethical considerations are also adhered to, to ensure that trial participants are protected and safeguarded against any harm that might arise as a result of participating in trials. The following documentation are elaborated for the general public and in particular companies and individuals intending to conduct clinical trials in Rwanda. However, new application to conduct a clinical trial in Rwanda is required for the following categories of products/circumstances.

Rwanda FDA has adopted a risk-based approach to post market surveillance. It is a method that concentrates limited resources on the areas considered most likely to pose a risk of quality defects due to limited resources. PMS is one of the most challenging regulatory function to implement, which calls for close collaboration within the regulatory authority and among the authority stakeholders. Considering that the number of pharmaceutical products available in the market is large, the high cost of sampling and testing and the human resources needed, it is not conceivable to control the quality of all products in the market. Applying risk0based approach on the implementation of PMS has become a necessity. The authority has adopted the risk-based approach at all levels starting from the planning to sampling, testing and regulatory action taking.

Rwanda FDA is the regulatory authority in Rwanda. The Authority has a website with detailed information on each of the services that they offer. The website also contains guidelines to the process of conducting registration, licensing, surveillance, quality control, imports and exports control as well as documents and other requirements required from the applicants. Even though the website is not connected to the REC – EAC's regulatory harmonization website, the regulation of medicines within the country is in line with most of the policies set in the EAC region. The country also benefits a lot from the regional harmonization policies.