WHO Lays Out Five-Year Regulatory Action Plan

As part of efforts to increase access to quality medical products around the globe, the World Health Organization (WHO) this month crafted a five-year plan to promote regulatory collaboration and reliance, and to help national regulatory authorities (NRAs) solve capacity issues and other challenges.

According to WHO surveys, only 30% of NRAs in 2018 had the capacity to effectively and efficiently regulate medical products, although there was greater capacity to regulate medicines and vaccines than other products. One way to combat this lack of capacity is through collaboration, with which WHO has succeeded in helping to spur 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 report says.

The report also outlines possible ways to combat the limited scope of WHO’s prequalification eligibility list, capacity issues in responding to public health emergencies, the flood of substandard and falsified medical products into LMICs and poor postmarket monitoring by national regulators.

On expanding its prequalification list, WHO on Tuesday revised both its essential medicines list and its essential diagnostics list. WHO is also working to help countries expedite the availability of medicines, vaccines and IVDs needed in public health emergencies.

The report also notes efforts to stem the tide of fake medicines, which WHO notes is a problem for one in ten medicines in LMICs, and the underreporting of adverse events linked to medical products.

“The introduction of products, including malaria vaccines and tuberculosis treatments, launched either exclusively in LMICs or simultaneously in low and high-income countries, is putting increased pressure on NRAs to meet their obligations and highlights the need for more proactive postmarketing monitoring. Another growing challenge is the spread of false safety concerns regarding vaccines via the Internet and social media,” WHO says.

The report also discusses the four main strategic priorities for WHO from now until 2023:

• Strengthen country and regional regulatory systems in line with the drive towards universal health coverage
• Increase regulatory preparedness for public health emergencies
• Strengthen and expand WHO prequalification and product risk-assessment processes
• Increase the scope and impact of WHO’s regulatory support activities

Commenting on the five-year plan, the US Pharmacopeia (USP) noted that in LMICs, quality-assured essential medicines remain out of reach for nearly two billion people.

“Beyond political will, 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.”

WHO’s five-year plan to help build effective and efficient regulatory systems