Rwanda FDA Encourages Registration and Promotes Quality and Safety for Cosmetics and Household Chemical Products Across Districts

From 16th to 18th January 2024, Rwanda Food and Drugs Authority (Rwanda FDA) facilitated a series of educational sessions in Rusizi, Nyamasheke, and Karongi Districts to encourage registration and promote the Quality and Safety for Cosmetics and Household Chemicals. The sessions focused on Cosmetics and Household Chemical Products Regulatory Affairs, and underscored the importance of product registration with Rwanda FDA prior to market distribution. Engaging stakeholders in the cosmetics and household chemical products industry in regulatory affairs has been identified as a key platform for disseminating regulatory services knowledge.

Rwanda FDA’s proactive engagement across districts underscores its commitment to promoting safety and regulatory compliance in the industry. Through collaborative endeavors and knowledge dissemination, Rwanda FDA sets a precedent for regulatory excellence, ensuring products meet stringent safety standards before entering the market.

The sessions also provided insights into Rwanda’s stringent regulatory framework, including the 2016 Ministerial order prohibiting certain ingredients in cosmetics. Hazardous ingredients such as hydroquinone and mercury found in skin-whitening creams were highlighted, emphasizing the risks associated with their usage, which can lead to adverse effects on the skin and potentially contribute to non-communicable diseases such as cancer, diabetes, and high blood pressure. Stakeholders, including retailers and manufacturers, expressed their commitment to prioritizing consumer safety.

Turikumana Flavien, a representative of cosmetics and household chemicals retailers from Rwimbogo sector in Rusizi District, emphasized the significance of peer education. He said ‘’I am committed to sharing insights on the importance of product registration with fellow retailers to prioritize consumer safety.’’

Dusenge Priscilla, a cosmetics retailer from Nyamasheke District, highlighted the pivotal role of the sessions in shaping cosmetics and household chemicals business practices. She said ‘’These sessions have reshaped my approach to product selection, ensuring avoidance of cosmetics containing harmful ingredients and prioritizing my clients ‘well-being”.

Nzamwita Alphonse, a retailer of household chemicals and manufacturer of food products from Nyamasheke District, acknowledged the invaluable guidance provided during the sessions, stating that the advice on proper products storage and avoidance of banned ingredients will be instrumental in enhancing product quality and safety.

Ufitamahoro Christine, a pharmacist from Karongi District, underscored the importance of consumer safety education. She said ‘’As healthcare professionals, it is imperative to educate clients on the risks associated with prohibited ingredients in cosmetics such as mercury and hydroquinone, to empower clients to make informed choices.’’

Dr. Janvier Mukiza, the Division Manager for Cosmetics & Household Chemicals Registration at Rwanda FDA, emphasized the collaborative effort required for consumer protection, stating that collaboration among stakeholders is essential to safeguard consumer health. ‘’Rwanda FDA remains steadfast in ensuring the safety and efficacy of regulated products,’’ he added. He reiterated the Authority’s commitment to protecting public health and promised continuous partnership, urging stakeholders to engage closely with Rwanda FDA.

The sessions also covered other regulatory functions, including Premise Licensing, Good Manufacturing Practices (GMP), Import and Export requirements, and Market Control. Attendees gained a comprehensive understanding of regulatory services/functions, especially the purpose of registration of cosmetics and household chemical products.

Collaborative Efforts Between Rwanda FDA and Patient Associations to Strengthen Pharmacovigilance Practices

To enhance pharmacovigilance practices and ensure the safety and quality of pharmaceutical products, the Rwanda Food and Drugs Authority (Rwanda FDA) convened a meeting with representatives from various patient associations. Held on January 29th, 2024, at the Rwanda FDA Head Office, the meeting aimed to foster collaboration and dialogue between the regulatory authority and patient associations on pharmacovigilance practices.

Pharmacovigilance is critical in ensuring the safety and efficacy of pharmaceutical products in Rwanda’s healthcare system. Recognizing the importance of engaging patient associations in this endeavor, Rwanda FDA organized a meeting to facilitate collaboration and exchange of insights on pharmacovigilance practices.

The primary objective of the meeting was to increase consumer engagement in pharmacovigilance activities through the established pharmacovigilance system by Rwanda FDA. By strengthening collaboration with patient associations, the Rwanda FDA seeks to enhance the reporting of adverse drug reactions (ADR) and adverse events, ultimately contributing to improved patient safety.

Representatives from patient associations, including Stroke Action Rwanda, Breast Cancer Association, Rwanda Diabetes Association, Reseau Rwandais des Personnes Vivant Avec le VIH/SIDA, and Rwanda Non-Communicable Diseases (NCD) Alliance, actively participated in discussions and provided valuable insights.

Key discussions centered on strategies to strengthen the pharmacovigilance system in Rwanda, increase awareness of pharmacovigilance programs among patients, and encourage reporting of adverse events.

‘’As patient advocates, we are committed to working closely with the Rwanda FDA to ensure the safety and quality of pharmaceutical products for our communities.’’ Said Ms. Kibugu De Cuir CARORLYIN Philipa, CEO of Breast Cancer Initiative East Africa.

‘’We believe that educating patients about pharmacovigilance is crucial in empowering them to report any adverse reactions they experience.’’ RemarkedbyMr. Alphonse Mbarushimana, Executive Director of Rwanda Non-Communicable Diseases (NCD) Alliance.

In addition to highlighting challenges and proposing solutions, the patient association representatives expressed their commitment to collaborating closely with the Rwanda FDA to ensure the quality and safety of pharmaceutical products.

The collaborative efforts between Rwanda FDA and patient associations signify a significant step towards enhancing pharmacovigilance practices in Rwanda. By actively involving patient associations, the Rwanda FDA aims to empower patients to play a more active role in safeguarding their health and promoting medication safety.

The meeting received positive feedback from all participants, underscoring the significance of collaboration between regulatory authority and patient associations in promoting pharmacovigilance and safeguarding public health.

Rwanda FDA remains dedicated to fostering continued collaboration with patient associations and other stakeholders to enhance pharmacovigilance practices and ensure the safety of pharmaceutical products for all Rwandan citizens.

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.

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.