Twinning project between EU and Rwanda FDA on access to medicines begins – RNA NEWS

The Secretary of State to the Minister of Health Yvan Butera chaired the launch event of the twinning project between the European Union (EU) and the Rwandan Office of Food and Pharmaceutical Products called “Rwanda FDA” for Rwanda Food and Drugs Authority.

During the implementation of this twinning project, the EU will be represented by a consortium of medicines regulatory agencies from its seven Member States: France, which leads this consortium, Germany, Belgium, Lithuania, Sweden , Austria and Greece.

The project aims to scale up the capacity of the Rwandan drug regulatory agency, working on the framework, procedures and key regulatory functions related to medicines, in order to facilitate importation but also, local production and the use of health products including vaccines on their territory.

Started in June 2022, this project aims to ensure that the people of Rwanda have access to locally manufactured, safe, effective and quality medicines and vaccines.

In his remarks, Secretary of State Yvan Butera said the launch of this twinning project is an important step towards achieving the country’s goal of ensuring equitable and affordable access to quality health services for all Rwandans through quality regulation of medical products.

“This is a project carried out by Rwanda in partnership with European Union countries to manufacture quality vaccines that meet international quality standards. It is to protect Rwandans who must have healthy health. We are working with different institutions to achieve this goal. Our laboratories will be equipped to reach these international standards and we will expect these goals to sell our vaccines even outside”, declared the Secretary of State Yvan Butera.

The twinning between Rwanda FDA and EU countries provides access to expert missions, seminars, workshops, trainings and study visits among others

“In sub-Saharan Africa, no other twinning cooperation has attracted such a large consortium. As each Member State involved can bring its own areas of expertise, we are convinced that this partnership will bring you the greatest possible value,” said Belen Calvo Uyarra, EU Ambassador to Rwanda.

“The EU is very proud of Rwanda’s mission to turn what has been a challenge, Covid-19, into an opportunity for the country to produce vaccines in Rwanda and for the continent. The EU is committed to supporting the country in this initiative. And so we are working with the Rwanda FDA, and in all the regulatory work and in the whole ecosystem to be able to facilitate the production of the vaccines and the commercialization of the vaccines from Rwanda. So we are really proud of the work that the government and Rwanda FDA are doing in this regard. And so we are taking the Member States, the practitioners, therefore those who do the work in the regulatory agencies of the Member States, so that they can share their experience with the Rwanda FDA, build partnerships which will therefore allow us to move forward on this agenda. production and equitable access to vaccines on the continent,” continued Ambassador Belen Calvo Uyarra.

Regarding the cost, she said that there are several pieces in this project. “This project costs two million euros. But there are many other initiatives that come and add to this European initiative. We do not ensure the commitment only in terms of money, we ensure the commitment in terms of the actors who have been mobilized in partnership with the government of Rwanda to advance in the production of vaccines”, she specified. .

As part of a global approach undertaken by Rwanda to improve its health sector, this project should enable the Rwandan regulatory agency, which is still young and needs to be strengthened, to be accredited by the WHO and recognized as a full regulatory authority.

This represents a very important challenge for Rwanda, which will then be able to welcome producers on its territory, and proceed with the validation of medical products from national production thanks to the regulatory framework and the control actions for imported products that will be put in place.

This twinning project should therefore lead to increased access to secure health products for Rwandan patients and Rwandan partner countries.

The contribution of European expertise to Rwanda FDA should also make it possible to encourage collaboration and the sharing of technical expertise between the European Medicines Agency (EMA) and the African Medicines Agency (AMA), whose headquarters is also located in Rwanda. (END)

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