WHO Outlines 5-Year International Regulatory Plan to Improve Drug and Medical Product Quality Assurance

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The U.S. Food and Drug Administration (FDA) has recalled blood pressure medicines at least five times this year over contamination issues. The drugs, which are used throughout the world, are manufactured by several different companies.

In 2014, in the Ituri district of the Democratic Republic of the Congo, 930 people were hospitalized and 11 had died after taking a drug for malaria, but which instead contained 13 mg of the antipsychotic drug haloperidol. About 60% of the people affected were children and 13 mg of haloperidol is about 20 times the maximum recommended dose for children.

These are just two examples of why the World Health Organization (WHO) developed a five-year plan to promote regulatory collaboration and reliance around the world and to assist national regulatory authorities (NRAs) in solving related issues.

According to surveys conducted by WHO, in 2018 only 30% of NRAs had the ability or capacity to effectively and efficiently regulate medical products. Thankfully, they were generally better at regulating drugs and vaccines than other products. WHO, as a result, felt a way to fight this lack of capacity is through collaboration, which has inspired initiatives in Africa and the Caribbean.

“In the coming years, WHO will play an important role in supporting the transition from donor-to-country-based procurement by strengthening regulatory systems for selected LMICs [low- and middle-income countries]. A strong voice from WHO will be needed to reduce the risk that individual countries may promote local production as part of their national development agenda without parallel efforts to strengthen regulatory systems—the only way to ensure that products meet international standards of quality, safety and efficacy,” the plan states.

The five-year plan has four main objectives. They are:

• Strengthen country and regional regulatory systems. This will not only improve how they function, but also speed product registration timelines and make cross-border collaboration easier.

• Increase regulatory preparedness for public health emergencies. This includes providing regulators with the expertise and knowledge to handle emergencies, including fast-tracking approval processes and crisis communication.

• Strengthen and expand WHO prequalification. This system has helped millions of people receive quality, cost-effective HIV drugs, as well as vaccinating millions of children via Gavi, the Vaccine Alliance. This is now expanding to include cancer drugs.

• Increase the impact of WHO’s Regulatory Support activities. This will be accomplished by aligning activities across all levels of the organization with a focus on the specific needs of different countries.

“True access and the health gains that come with it can only be achieved if globally, regionally and nationally health products do what they are meant to do—prevent illness and improve people’s health,” stated Mariângela Simão, assistant director-general for Medicines and Health Products at WHO. “They can only do that if sound regulatory systems are in place.”

The U.S. Pharmacopeia (USP) pointed out that in LMICs, essential drugs that have high-quality assurance remains out of reach for almost two billion people.

“Beyond political will,” USP noted, “solutions to quality challenges will depend on: 1. Strengthening regulatory systems toward WHO-listed authority status 2. Supporting local manufacturing within LMICs where possible 3. Maintaining and expanding the scope of WHO Prequalification (PQ) and quality assurance efforts 4. Improving the prevention, detection, and response to substandard and falsified health products.”