Rwanda FDA prepares for implementation of pharmaceutical pricing policy

RWANDA – Rwanda Food and Drug Authority (FDA) has launched a 3-day internal pre-validation workshop of regulations that will aid it in implementation of the National Pharmaceutical Product Pricing and Cost Containment Policy.

The FDA functions to protect public health through regulation of human and veterinary medicines, biological products, processed foods, poisons to mention a few.

It regulates products to ensure their quality and safety so as to protect the population of Rwanda from defective, falsified and substandard products.

The authority in collaboration with USAID Global Health Supply Chain has commenced activities towards the implementation of the policy.

The internal pre-validation consisting of Rwanda FDA’s technical team is the first step towards approving of these regulations.

“An executive validation with Rwanda key stakeholders including the Ministry of Health will be conducted where the regulations will then be disseminated to other stakeholders through a stakeholders’ workshop,” reported the authority in a statement.

Moreover, National Pharmaceutical Pricing Advisory Committee (NPPAC) will be established to oversee the implementation of the policy and adopt related regulations.

The government of Rwanda commissioned a study on how to contain pharmaceutical costs in 2019 which birthed the pharmaceutical cost policy.

The policy was then developed and adopted in 2020 to regulate the pharmaceutical market in Rwanda.

As a regulator, Rwanda FDA was tasked to implement the policy through development and application of strategic regulations, guidelines and working documents highlighted in the policy.

The policy is aimed at regulating the prices of pharmaceutical products with a view to putting an end to pricing malpractices by different players in the industry.

The government working together with Rwanda FDA and other relevant institutions will set the price range for each pharmaceutical product after considering factors such as manufacturer’s price, freight services involved among other costs.

Meanwhile, Rwanda FDA embarked on a campaign to foster awareness among stakeholders engaged in food business operations for them to adequately comply with food safety standards.

The training’s objective was to provide knowledge on Rwanda FDA’s role, functions, regulations and guidelines related to food safety standards required by the authority.

“We wanted factories to better understand what it takes to meet standards for premises as well as food quality and safety standards,” asserted Dr. Emile Bienvenu, Director General of Rwanda FDA.

The campaign is expected to increase the turn up of applications for premise licensing, importation and exportation both in numbers and quality.

It will also increase the compliance to different existing regulations and guidelines especially post marketing surveillance system, food promotion and advertisement control.

In addition, comprehensive data on possible issues facing industries towards safety compliance was compiled and a detailed report produced and shared with the management for planning purposes and decision making.

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