Rwanda FDA launches Banzurebe campaign to boost food and drugs safety

Rwanda Food and Drug Authority (FDA) has launched a three-month awareness campaign dubbed BANZA UREBE, which aims at igniting a nationwide movement for the fight against illicit drugs, expired products, and illegally manufactured beverages on the local market.  

Overall, it aims to ensure that Rwandans consume food and drugs that are safe and secure which are part of its mandate to protect the public health of the population.

Speaking during the launch, Martine UMUHOZA, the Deputy Director General of Rwanda FDA, urged Rwandans to always be vigilant consumers by checking expiration dates and scrutinizing product labels, and alert Rwanda FDA about any expired products, or illegally manufactured beverages on the local market to safeguard their health and well-being.

“We advise consumers to be vigilant by checking expiration dates and products labels, even alert us, but we also welcome products manufacturers and retailers to seek help from us, so that to produce standardized products”, she added.

The campaign entails various engagements with the public through radio, TV and several social media channels.

To facilitate the reporting process, the Rwanda FDA developed a dedicated helpline, such as 9707, and a WhatsApp chat number +250788457545, manned by a team of trained professionals, ready to receive calls and respond swiftly to every complaint.

The customer support electronic tool has also been created where all clients can submit their claims and complaints.

Rwanda becomes home of African Medicines Agency

The Rwandan Ministry of Health and the African Union have signed a host agreement for the African Medicines Agency (AMA) on Saturday, June 10th 2023.

This newly launched continental regulatory body for medical products, is set to start its work, with its headquarters in Rwanda.

Rwanda was selected to be the host of the agency during the 2022 African Union Executive Council meeting in Lusaka, Zambia.

AMA is a specialised AU agency intended to facilitate the harmonisation of medical products regulation throughout the AU in order to improve access to quality, safe and efficacious medical products on the continent.

Many AU member states including Rwanda ratified the treaty establishing the continental agency and deposited the legal instrument of ratification to the AU Commission.

On Saturday, June 10, Rwanda and the AU signed the host country agreement, an important step in getting the work of AMA started.

Speaking at the signing ceremony, Health Minister Dr. Sabin Nsanzimana said the institution will play a key role in building confidence in the quality of health products on the continent, promote cooperation and mutual recognition in regulatory decisions and facilitate the movement of health products.

The agency is tipped to enhance capacity of state parties to regulate medical products, to improve Africa’s access to quality safe, and efficacious medical products.

In a media interview, Minister Nsanzimana noted that the government of Rwanda has already provided space where the agency will operate, and that after the signing of the host agreement, a number of processes are going to follow.

The next steps will include getting leaders for the institution, putting in place facilities like laboratories, and so on.

The AU Commissioner for Health, Humanitarian Affairs, and Social Development, Minata Samate Cessouma, said AMA will hugely contribute to the production of medicine on the continent, and allow it to move across the continent.

Rwanda FDA kick-starts €2m Twinning project to improve medicinal products

Rwanda Foods and Drugs Auhtority has welcomed the EU-funded project dubbed “Twinning project” to strengthen the Authority in regulating medicinal products including vaccines.

The project launched on May 16, 2023 aims to promote drugs and food safety in Rwanda.

The launch brought together key stakeholders in the health sector, including government officials, health industry representatives, civil society organizations, and development partners.

The project was funded by the European Union Delegation and is implemented by Expertise France, a French technical cooperation Agency with the help of different health agencies of the European partner countries of the twinning.

The two-year project, to be implemented at the cost of 2 million Euros, seeks to improve its laboratory services, enhancing its capacity for risk assessment, and promoting the use of international standards and best practices.

The twinning project involves several vaccines and medicines regulatory agencies from EU Member States such as the French National Agency for the Safety of Medicines and Health Products (ANSM), Paul-Ehrlich-Institut – German Federal Institute for Vaccines and Biomedicines, Sciensano of Belgium and the State Medicines Control Agency of Lithuania.

Speaking during the launch, Dr. Yvan Butera, State Minister in the Ministry of Health commended team Europe for the continuous support and effort rendered to the health sector in Rwanda.

“A main priority for the Government of Rwanda is to strengthen health systems at all levels of service delivery in order to ensure universal accessibility of equitable and affordable quality health services for all Rwandans,” he said.

One of the country’s strategies to address this objective, he said, is to enhance the domestic value chain for pharmaceutical and vaccine manufacturing, which requires strengthening the national regulatory framework.

“This is the overall goal of this EU Twinning Project, which aims at strengthening Rwanda FDA’s regulatory functions related to medicinal products including vaccines,” he noted.

The project also looks at Strengthening of market surveillance and control function – vigilance and laboratory testing functions as well as supporting the establishment of the official batch release function for vaccines.

“The launch of this twinning project, which follows the agreement that was signed in June 2022, is a major step toward realizing the country’s goals of ensuring equitable and affordable access to quality health services for all Rwandans through quality regulation of medical products,” Minister of state said.

Since its implementation in October 2022, this twinning program has enabled the regulatory body-Rwanda FDA to adapt best practices borrowed from sister European regulatory agencies to Rwanda context, he said.

“We have no doubt that Rwanda FDA will keep up-to-date with the current innovations and developments in technology within the regulatory environment globally,” he added.

He appreciated the efforts deployed through the European Commission by the consortium partner countries to support the Republic of Rwanda in strengthening its medicines’ regulatory framework.

It is expected that about 200 experts will be able to support the Rwanda FDA through field visits during which they will share their expertise with designated Rwanda FDA Staff.

The project team consists of experts from health agencies from the European member states which are part of the twinning who will work together with Rwanda FDA Staff to achieve the project objectives.

It is set to provide the Rwanda FDA with access to support from EU National Regulatory Agencies.

EU Ambassador to Rwanda, Belén Calvo Uyarra said: “EU is a proud partner of Rwanda in manufacturing and access to vaccines, medicines and health equity.”

“In Sub-Saharan Africa, no other Twinning cooperation has attracted such a sizable consortia. As every Member State involved can bring their own areas of expertise, we are confident that this partnership will bring you the highest possible value,” she noted.

With Rwanda soon to start producing vaccines, this twinning cooperation provides support with a view to ensure Rwanda FDA has the necessary regulatory procedures in place for future vaccine manufacturing, she added.

The wait is over: First batch of BionTech biontainers arrive in Rwanda

Rwanda has received the first batch of BioNTainers to begin an end-to-end mRNA vaccine production in Africa for the first time.

The containers arrived exactly 3 years since the first Covid-19 case was detected in Rwanda on 14 March 2020.

BioNTainers will be equipped to manufacture a range of mRNA-based vaccines targeted to the needs of the African Union member states, which could conceivably include the Pfizer-BioNTech COVID-19 vaccine and BioNTech’s investigational malaria and tuberculosis vaccines, if they are successfully developed, approved or authorized by regulatory authorities.

The estimated initial annual capacity of the Pfizer-BioNTech COVID-19 vaccine notably will be about 50 million doses.

Commenting on the arrival of the BionTainers, Rwandan Minister of Health, Dr. Sabin Nsanzimana described it as a key milestone in the journey.

“The BioNTainers which arrived today are a key component of what is expected from BioNTech in this journey to establish the vaccine manufacturing facility. There are other logistics still on the way but this is a major milestone in this process,” he said.

“The experts are already here and we expect the facility to be up and running soon,” added Minister Nsanzimana.

Manufacturing in the BioNTainers in Rwanda is expected to commence approximately 12 to 18 months after their installation.

Meanwhile, the Rwandan facility, with a size of about 30,000 square meters, will be initially equipped with two BioNTainers (one for the production of mRNA, and one for the production of the formulated bulk drug product).

The company expects to set up additional factories in Senegal and South Africa in close coordination with its partners in the respective countries.

The initial site will become a node in a decentralized and robust African end-to-end manufacturing network.

All vaccines to be manufactured in the network will be dedicated to people residing in member states of the African Union.

WHO formal benchmarking kicks off in Kigali

A team of nine assessors from the World Health Organization have started a 5-days exercise on Monday, December 12, 2022 to benchmark the system for regulating medicinal products in Rwanda against the WHO global benchmarking tool (GBT) indicators and sub-indicators

The objectives of the benchmarking visit are to benchmark the performance of the regulatory system in the areas of medicine and vaccine regulations against the WHO NRA Global Benchmarking Tool (GBT) in Rwanda and measure the maturity of the system. In addition, they will also update the Institutional Development Plan (IDP) of Rwanda FDA and other involved affiliated institutions to address existing and/or potential gaps as well as prioritization of recommendations for implementation to raise the overall maturity of the regulatory system up to level three. Finally, the team will also update the roadmap for regulatory system strengthening of NRA of Rwanda including support from WHO and other interested parties.

Addressing the participants during the launch of the exercise at Rwanda FDA headquarters on Monday, the State Minister in charge of Primary Health Care, Dr. Yvan Butera promised an enhanced support to Rwanda FDA to advance the local manufacturing of vaccines with the aim of advancing bio manufacturing on the whole continent.

“The Government of Rwanda is committed to support Rwanda FDA’s efforts in catalyzing a global dialogue and in collaborating with other regulatory agencies and coalitions, development organizations, academic institutions to identify effective approaches to strengthen the national regulatory systems for medical products,”, he noted.

Rwanda is also committed to ensure high-level services in delivering regulatory interventions for the pharmaceutical field and continues to avail all required resources to Rwanda FDA such as human resources, capacity development, financial, infrastructure, added Minister Butera.

Among the preparations of the formal benchmarking exercise, included the recent passing of the Law Relating to Research on a Human Being in August 2022.

This will be followed by the approval of the Draft Ministerial Order Determining the Functioning Organization and Structure of the Rwanda National Ethics Committee during the upcoming Cabinet meeting.

Delivering his remarks, Professor Emile Bienvenu, the Director General of Rwanda Foods and Drugs Authority, expressed gratitude to the support of World Health Organization in this journey towards the formal benchmarking, which is being launched.

He highlighted that Rwanda FDA received technical assistance of different foams from WHO in February and August 2022, which aimed at building the capacity of Rwanda FDA teams and contributed to addressing formulated IDPs. WHO has significantly assisted Rwanda FDA to improve readiness in all the functions.

“I thank very much the World Health Organizatin for all this support”.

The WHO- Regulatory Systems Strengthening Mission Team Lead, Dr. Alireza Khadem Broojerdi asserted that this should not be called an assessment but rather a peer review.

He indicated that his team will learn a lot from what Rwanda is doing, and commended the government’s efforts towards ensuring the public health of the population through strengthening the regulatory functions of all the medicinal products.

How did it start?

Rwanda FDA attended the WHO workshop for National Regulatory Agencies from the East African Community Partner States held from February 27th to March 1st 2018 in Mombasa, Kenya and formal benchmarking was conducted from the 6 to 9 November 2018. 

From the time Rwanda FDA was first benchmarked in 2018, significant progress in Institutional Development Plans implementation was noted and technical support from different experts was provided for all regulatory functions including the Global Benchmarking Tools.

The technical support provided to Rwanda FDA also included a virtual support mission from May 27th to 28th 2021 to provide an overview of the WHO computerized Global Benchmarking Tool and to provide a practical demonstration of the latter.

The assisted WHO self-benchmarking conducted in September 2021 highlighted additional gaps that required further technical assistance.  Rwanda FDA then requested support for capacity building from WHO on the assessment of pre-clinical, clinical trials authorization and market authorization, and WHO conducted a mission from the 14 February to 4 March 2022 to provide the requested support.

Further technical support was provided for the regulatory inspection (RI) function and licensing establishment (LI) function from 15 to 18 August 2022. During that mission, additional technical support needs were identified across the remaining six regulatory functions and technical support was provided virtually from 10 to 11 October 2022.

Authority recalls Ketoconazole oral tablets

Rwanda Foods and Drugs Authority, in its duty of ensuring the public health of the population, has withdrew Ketoconazole oral tablets from the Rwandan market.

The move follows the recommendations from the National Pharmacovigilance Advisory Committee.

Ketoconazole oral tablets are normally used to treat fungal infections.

Among the duties of Rwanda FDA governing pharmacovigilance for pharmaceutical products and medical devices, the authority has conducted a deep analysis and concluded that “Ketoconazole has higher risks of liver injury than its benefits when treating fungal infections”.

Hence the authority withdrew all the brands of Ketoconazole oral tablets from the Rwandan market and called for alternative drugs for the treatment of fungal infections.

It is against this background that Rwanda FDA ordered all Central Medical Stores

Pharmaceutical Wholesalers, Importers, Retail Pharmacies, Public and Private health facilities, Health professionals and the general public at large to stop the distribution and return the withdrawn medicines to the suppliers for management purposes.

FDA also urged all the importers and Suppliers of withdrawn products to report the quantities imported, quantities distributed, quantities returned and hand the final stock to Rwanda FDA within 15 days from the date of the withdrawal.

Importers of the mentioned medicines were requested to arrange the refund mechanism to their clients as per article 18 of the regulation governing the recall of regulated products.

For Health Professionals especially medical doctors and pharmacists, they were requested to stop prescribing and dispensing Ketoconazole oral tablets and use other alternative treatments.

Rwanda FDA’s mandate to ban medical products harmful to the population are established by the law Law Nº 003/2018 of 09/02/2018 establishing Rwanda Food and Drugs Authority

(Rwanda FDA), especially in articles 8 paragraphs 2 and 13 and reference is also made to regulation No CBD/TRG/016 governing pharmacovigilance for pharmaceutical products and medical devices, especially in article 26.

Prior to Ketoconazole, the authority had banned Toblereno chocolate and Broncalene sirups among other commodities.

Signing of Memorandum of Understanding between Rwanda Food and Drugs Authority (Rwanda FDA) and Ghana Food and Drugs Authority (Ghana FDA)

Rwanda FDA , on 24th June, 2022 signed a memorandum of understanding with Ghana FDA that will allow both National Regulatory Authorities to collaborate in areas of mutual interest, especially in the processes and procedures of the World Health Organization (WHO) Global Benchmarking Tool (GBT) and technical assistance related to the regulation of medicines and vaccine.

To support the vaccine manufacturing agenda at the country level, Rwanda FDA has to attain World Health Organization maturity level 3 which is a prerequisite level for Rwanda FDA set by World Health Organization to allow manufacturers in Rwanda to apply for vaccine prequalification. Rwanda FDA was self-assessed in September 2021 and aims to be formally assessed by WHO by end of 2022. This MoU will therefore see Ghana FDA support Rwanda FDA in the attainment of WHO Global Benchmarking Maturity Level 3 (WHO GBT ML 3) since the latter has already reached Maturity Level 3

The MoU was signed by the Director-General of Rwanda FDA, Dr. Emile Bienvenu, and Delese Mimi Darko, Chief Executive Officer, Ghana FDA. On hand to witness the signing of the MoU was Dr. Tharcisse Mpunga, Minister of State in the Ministry of Health in charge of Primary Healthcare, Dr. Karita Etienne , the Chairman Board of Directors, Rwanda FDA and other dignitaries.  

European Union strengthens capacity of Rwanda FDA through the Twinning cooperation with EU Member State agencies

The European Union on 22nd June, 2022 launched a Twinning cooperation that will provide Rwanda Food and Drugs Authority with a peer-to-peer partnership including several EU Member State regulatory agencies. This Twinning agreement was signed between the Head of Delegation of the European Union to Rwanda, Ambassador Nicola Bellomo and the Ambassador of France to Rwanda Antoine Anfre in the presence of the Minister of Health of Rwanda Dr Daniel Ngamije and Director General of the Rwanda FDA, Dr Emile Bienvenu. France is the lead Member State of the consortia, which is further composed of Germany, Belgium and Lithuania. The Twinning project aims at supporting the Authority improving the enabling environment for regulation of medicinal products and vaccines in the country.

The EU also delivered critical quality control laboratory equipment to the Rwanda FDA, including key integrated information management system equipment, to allow the Authority to establish a more modern Quality Control Laboratory and thereby support its role to ensure the safety, efficacy and quality of vaccines and pharmaceutical products.


This week, Rwanda FDA’s Director-General, Dr. Emile Bienvenu, received Dr.Brian Chirombo, WHO’s country representative to discuss areas of collaboration in capacity building for vaccine regulation and support towards the Authority’s achievement of Maturity Level 3.

While Rwanda is preparing to initiate vaccine manufacturing in Africa, Rwanda FDA continues to identify and focus on areas of work for regulatory strengthening. The Authority is therefore keeping close collaboration with different partners such as World Health Organisation among others as a strategy increase to support across all its functions

Rwanda FDA is dedicated to delivering high-level services by building a regulatory environment that will capacitate quality assurance of pharmaceutical products as well as local production of vaccines.