From 16^th to 18^th 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 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 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.

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.

The European Union on 22^nd 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.