A team of nine assessors from the World Health Organization have started a 5-day
s 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.