Rwanda FDA staff empowered on fire safety

On September 11th, staff members of the Rwanda Food and Drugs Authority (Rwanda FDA) participated in a comprehensive fire safety training led by the Rwanda National Police Fire and Rescue Brigade (FRB). The session was designed to strengthen workplace safety by equipping employees with practical skills and knowledge on preventing, managing, and responding to fire incidents.

This one-day training session, led by Chief Inspector of Police (CIP) Jonas Rizinde, focused on empowering Rwanda FDA employees with practical knowledge and skills to prevent and respond to fire emergencies. Participants were educated on key preventive measures, such as identifying potential fire hazards, understanding fire emergencies and implementing precautionary strategies in both professional and domestic settings.

A core component of the program involved explanation and demonstrations of firefighting and rescue equipment where staff learned how to effectively use tools like fire extinguishers and fire blankets that can make a critical difference in the early stages of a fire outbreak. CIP Rizinde emphasized the broader impact of the training, urging participants to become ambassadors of fire safety. “I encourage all Rwanda FDA staff to share the knowledge and skills they’ve gained with their families and communities,” he stated.

He highlighted common fire risks, including overloading electrical installations, tampering with wiring, and mishandling electrical appliances, which can lead to short circuits. For instance, he advised on the safe use of cooking gas (LPG). Rwanda FDA as an institution dealing with laboratories and heavy equipment along with other unique works, CIP Rizinde specifically warned about the dangers of unintended chemical reactions, which could spark fires in such settings. He advised staff to remain vigilant, conduct regular safety audits, and adhere to strict protocols to mitigate these risks and contact 111 in case of emergency.

Rwanda FDA Attains WHO Maturity Level 3

Kigali – Rwanda, 6th December 2024 – Rwanda Food and Drugs Authority (Rwanda FDA) attains Maturity Level 3 (ML3) for the regulation of medicines and vaccines (non-producing), a milestone conferred by the World Health Organization (WHO). Maturity level 3 confirms stable, well-functioning and integrated regulatory systems capable of ensuring the quality, safety, and efficacy of medical products.

This recognition affirms Rwanda’s commitment to maintaining the highest standards in public health protection through robust regulatory oversight and demonstrates Rwanda FDA’s capability to effectively regulate and monitor the safety, quality, and efficacy of medicines, vaccines, and medical devices in Rwanda. It assures the public and our partners that Rwanda’s pharmaceutical regulatory framework meets international standards.

This achievement follows a comprehensive assessment process and successful implementation of WHO recommendations. The WHO’s assessment of medicines regulatory authorities examines regulatory systems on their framework and functions. It designates the level of regulatory oversight in countries on a scale of one to four. The benchmarking of the National Regulatory System of Rwanda, represented by Rwanda FDA was formally conducted in December 2022 and concluded in October 2024, in close collaboration with WHO.

“This is a proud moment for Rwanda FDA and Rwanda as a whole. Achieving Maturity Level 3 reflects the Government’s sustained investment in strengthening the national pharmaceutical regulatory systems. It is a testament to the unwavering support of the Government of Rwanda in building robust health systems, and the dedication of Rwanda FDA staff, and stakeholders towards public health protection. As we celebrate this achievement, we reaffirm our resolve to sustain and build upon these standards to protect the public health,” said Prof. Emile BIENVENU, Director General of Rwanda FDA.

With this achievement, Rwanda FDA joins an elite group of 18 regulatory authorities worldwide that have reached Maturity Level 3, and is now among the first eight (8) in Africa to attain this milestone.

Rwanda FDA Signs MoU with ICGEB to Enhance Training and Collaboration

Kigali, Rwanda – On 25th July 2024 the Rwanda Food and Drugs Authority (Rwanda FDA), the University of Rwanda (UR), the Rwanda Forensic Institute (RFI), the Rwanda Biomedical Centre (RBC), and the African Biomanufacturing Institute(ABI) signed a Memorandum of Understanding (MoU) with the International Centre for Genetic Engineering and Biotechnology (ICGEB).

This partnership will enable Rwanda FDA to access ICGEB state-of-the-art laboratory facilities and receive advanced Good Manufacturing Practice (GMP) training for new technologies relating to biological manufacturing.

The MoU was signed by Prof. Emile Bienvenu, Director General of Rwanda FDA, and witnessed by the Honourable Minister of Education, Gaspard Twagirayezu.

Kwibuka30: Rwanda FDA Pays Tribute to Victims of the 1994 Genocide Against the Tutsi

Kigali, Rwanda – May 10th, 2024

As Rwanda observes the 100 days of Kwibuka30, marking the 30th remembrance of the 1994 Genocide Against the Tutsi, Rwanda Food and Drugs Authority (Rwanda FDA) gathered at its headquarters in Nyarutarama to remember the victims and stand in solidarity with survivors.

The event, attended by the entire staff of Rwanda FDA, as well as representatives from Ibuka at both the Gasabo District and Remera Sector levels, served as a moment to reflect on the significance of this period. Speaking at the event, Prof. Emile BIENVENU, the Director General of Rwanda FDA, underscored the importance of commemorating the 1994 genocide against the Tutsi and reiterated the collective responsibility to combat genocide ideology.

“We take this moment to honour the memory of our beloved ones who were massacred during the 1994 genocide against the Tutsi,” Prof. BIENVENU remarked. “It is also a time to reaffirm our commitment to national unity, and reconciliation, and to deepen our understanding of the horrors of genocide, to root out its ideology from our society.“

During the event, Nicolas Rwaka, Director of Research at the Chancellery for Heroes, National Orders and Decorations of Honour (CHENO), provided insights into the historical context of the 1994 genocide against the Tutsi, highlighting how it was systematically orchestrated by the government of the time. He urged everyone to never allow anyone to say the history of the 1994 Genocide against the Tutsi otherwise.

The Kwibuka30 event at Rwanda FDA served as a reminder of the resilience of the Rwandan people and their commitment to building a society based on unity, reconciliation, and mutual respect. As the nation continues to commemorate this important solemn occasion, Rwanda FDA remains dedicated to promoting peace, tolerance, and preventing genocide ideology.

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.

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.

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.