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Regulatory Focus™ > News Articles > 2020 > 1 > NASEM Calls on WHO to Expand its Prequalification Program

NASEM Calls on WHO to Expand its Prequalification Program

Posted 15 January 2020 | By Zachary Brennan 

NASEM Calls on WHO to Expand its Prequalification Program

The National Academies of Sciences, Engineering, and Medicine (NASEM) on Wednesday published a new report outlining ways to strengthen regulators worldwide, and one of the report’s recommendations is for the World Health Organization (WHO) to expand its prequalification program for medical products.

The prequalification program is a way for the WHO to increase access to certain HIV/AIDS, malaria, tuberculosis and other generic drugs and active pharmaceutical ingredients in low- and middle-income countries.

The program is necessary, as NASEM estimates poor quality vaccines cause about 70,000 deaths from childhood pneumonia each year and poor quality antimalarials cause between 8,500 and 19,800 deaths per year (based on WHO estimates of 435,000 malaria deaths a year, 93% of which occur in Africa).

“A 2019 assessment found that every dollar spent in running prequalification returns 30 to 40 times that amount and in savings during procurement and by leveling the playing field to allow good manufacturers in low- and middle-income countries entry to international markets,” NASEM said in its report, which was sponsored by the US Food and Drug Administration (FDA).

The academies call on WHO to expand prequalification to include treatments for cancer, diabetes and other diseases with a high global burden, especially as of late 2019, only about 17% of products on the WHO Model Essential Medicines List have even one prequalified supplier. Although most recently, the first trastuzumab biosimilar was prequalified last month.

“Products for smaller but important markets, such as neglected diseases, should also be considered. There is also clear demand for any product where a third or more of the total market by volume is subject to global procurement. Medicines that present a particular challenge to regulators because of the complexity of manufacturing would also be good candidates (‘t Hoen et al., 2014), as would anti-infectives since the risk of drug resistance makes the quality of these products a global public good,” the report notes.

NASEM further explains how the WHO prequalification program provides for the assessment, inspection and ongoing re-inspection of manufacturers and consistency testing and quality control for certain vaccines, medicines and other medical products. “As such, it can be a boon to procurement agencies, acting as a proxy regulatory approval, something especially valuable in managing the combination of limited regulatory capacity and foreign suppliers,” the report says.

The call for such an expansion comes as in Africa, for example, all but one country has a medicines regulator, although only seven of these regulators have the legal mandate for essential regulatory functions.

“This means that even some basic medicines regulatory jobs such as market authorization, inspection, and quality control are neglected in a part of the world with serious health needs and demand for medical products. The situation is no better in many larger countries” like India and China, the report notes.

Such an expansion of the prequalification program may also help to stem the spread of informal medicine markets.

“Regulatory agencies may be more likely to consider aggressive enforcement as a way to combat the informal medicines market, though enforcement alone is unlikely to put informal sellers out of business. In low- and middle-income countries, the informal market is a response to a demand for medicines that exceeds the supply. Accreditation is one tool with promise to improve the reach of good-quality medical products; consumer education and mobile technology can also be effective,” the report says.

The report also recommends that the National Institutes of Health, in collaboration with FDA and the US Agency for International Development, should develop a network of Global Centers of Excellence in Regulatory Science for research and capacity building to identify and address the challenges of ensuring food and drug safety in low- and middle-income countries.

In addition to this latest report, NASEM in November published a report on cooperation among drug regulators.

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