RWANDA— The Minister of Health, Dr. Yvan Butera, has welcomed the “Twinning Project,” a project funded by the European Union (EU) aimed at strengthening the regulatory capabilities of the Rwanda Food and Drug Authority (Rwanda FDA), particularly in the regulation of drugs and vaccines.

The EU, Twinning project aims to strengthen the Rwanda FDA in its regulatory functions related to medicinal products including vaccine manufacturing standards.

The US$2.23 Million project will be fully funded by the European Union and implemented by Expertise France, a French technical cooperation Agency.

The two-year Twinning Project will also involve other regulatory agencies from EU Member States.

They include 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.

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 seeks to improve the Rwanda FDA laboratory services, enhance its capacity for risk assessment, and promote the use of international standards and best practices.

The project also looks at strengthening market surveillance and control functions, vigilance and laboratory testing functions as well as supporting the establishment of the official batch release function for vaccines.

Dr. Yvan Butera, the State Minister in the Ministry of Health, emphasized the Rwandan government’s commitment to strengthening health systems at all levels of service delivery, aiming to provide universal access to equitable, affordable, and high-quality healthcare for all citizens.

In order to achieve this objective, there is a need for improved standards in vaccine production.

Dr. Yvan stated, “Enhancing the domestic value chain for pharmaceutical and vaccine manufacturing is one of our key strategies in addressing this objective, which necessitates bolstering the national regulatory framework.”

The Minister highlighted that this is a significant milestone towards realizing Rwanda’s goal of ensuring equitable and affordable access to quality healthcare services for all, achieved through effective regulation of medical products.

Rwanda’s ambitious vaccine manufacturing plans

The EU Ambassador to Rwanda, Belén Calvo Uyarra, expressed that the investment commitment of US$2.23 million is just the beginning. There are numerous future opportunities for EU partners to further invest, particularly in the vaccine ecosystem of Rwanda, where BioNTech has already made investments.

In March 2023, Rwanda procured six ISO-sized shipping containers to establish the first BioNTainer in Europe, aimed at scaling up vaccine production in Africa.

The BioNTainer, BioNTech’s first modular factory, is constructed from shipping containers and has been thoroughly inspected by the company’s manufacturing experts.

Each BioNTainer consists of one drug substance and one formulation module, covering an approximate total footprint of 800 square meters.

According to company executives, these units are expected to produce around 50 million doses per year of BioNTech’s Pfizer-partnered COVID-19 vaccine.

BioNTech anticipates starting vaccine production within a year of the BioNTainers’ delivery, with an estimated 100 individuals to be employed by 2024.

Other Twinning Projects

According to the EU, Twinning is a European Union instrument for institutional cooperation between Public Administrations of EU Member States and beneficiary or partner countries.

Twinning projects bring together public sector expertise from EU Member States and beneficiary countries with the aim of achieving concrete mandatory operational results through peer-to-peer activities.

In 2021, 22 out of 27 Member States were involved in Twinning projects either as a lead Member State or as a junior partner.

A notable example of an EU Twinning Project is the Peer-to-Peer institutional support to the Office of the Auditor-General in Zambia, which was launched in 2021 with a budget of US$2.23 million.

Moreover, the Twinning project with the Office of the Auditor-General has been implemented by a European consortium consisting of Austria, Finland, and Croatia.

This project is part of the EU 11th European Development Fund funded “Effectiveness and Transparency in Management of Public Resources (EFFECT)” Programme.

The EFFECT program aims to strengthen Public Financial Management, including greater accountability and transparency, in Zambia.

Another twinning project in the work is the Jordan Integrity and Anti-Corruption Commission in cooperation with the European Union

The Twinning project aims to support institutional efforts in Jordan to strengthen integrity and prevent corruption.

This project is managed by the Jordanian Integrity and Anti-Corruption Commission (JIACC) and was launched in 2021 with a budget of US$7.2 million.

The JIACC twinning project will be implemented in cooperation with experts and specialists from the Special Investigation Service of the Republic of Lithuania (STT), the Police Department under the Ministry of the Interior of the Republic of Lithuania (PD), Chief Official Ethics Commission (COEC), and the Central Project Management Agency (CPMA).

Additionally, the project will involve collaboration with the Austrian Agency for European Integration and Economic Development (AEI), working together with the Jordanian Integrity & Anti-Corruption Commission (JIACC).

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