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.

BUILDING CAPACITY FOR VACCINE REGULATION

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.