Strengthened regulatory systems are needed to improve drug safety, says report

A report suggests that to achieve the United Nations’ (UN’s) goal of achieving universal health coverage by 2030, countries must strengthen their drug regulatory systems. It suggests implementing a new global regulatory framework that could be supported by US government agencies, international development donors and the World Health Organization (WHO) to strengthen the capacity of drug regulators.

The report indicates that investments should prioritise the expansion of WHO’s approval and quality control processes for priority medicines and vaccines; the development of tools for rapidly screening drug quality; and improving the evaluation of how well regulatory agencies are performing. It also suggests that the growing middle class has shifted consumer interest towards safer medicines, requiring more regulator time.

Among the challenges facing low- and middle-income countries is the limited access to quality medicines. If implemented, the study suggests, the WHO prequalification process could help regulators to ensure they are licensing safe medicines, with appropriate quality controls. The prequalification process, currently applied to HIV, tuberculosis and malaria drugs, must now be extended to include medicines for chronic diseases, including cancer, diabetes and antibiotics, according to the report.

Although regulation is challenged by limited access to licensed pharmacies in rural areas and a tendency to buy medicines from informal sellers, risk reduction strategies need to be put in place in low- and middle-income countries, says the report. Theses could include accreditation/licensing of sellers, consumer education and increased access to regulated products.

“Investing in stronger national regulatory systems and better collaboration among them puts their focus where it should be – on improving public health,” said Catherine Woteki, professor in the department of food science and human nutrition at Iowa State University, US and chair of the committee that wrote the new report. “These investments have positive spill-over effects for governments, health systems and the food and pharmaceutical industries.”

The report recommends the develop a network of Global Centers of Excellence in Regulatory Science, which would research regional product safety needs and provide strategies to improve local manufacturing and quality control. It also suggests benchmarking assessments could be set up to motivate improvements to regulatory systems where the results are made public so that countries can compare with possible financial rewards from development donors.

Report by the Committee on Stronger Food and Drug Regulatory Systems Abroad.