The World Health Organization expanded its prequalification programme to include contraceptives, tuberculosis screening technologies, and male circumcision devices. The update addresses regulatory gaps in an estimated 70 percent of countries that report inadequate or weak oversight for medicines and vaccines.
WHO Expands Medical Device Oversight to Target Weak Regulatory Systems
The expanded framework sets international quality, safety, and performance standards for global procurement. Independent, standardized assessments evaluate products before listing them for United Nations agencies, procurement organizations, donors, and national authorities. Dr. Sylvie Briand, WHO Chief Scientist and Assistant Director-General a.i. for Health Systems, Access and Data, stated that the expansion strengthens confidence in essential health products and helps nations broaden equitable access. The initiative particularly assists countries with limited regulatory capacity where health product oversight lags behind medicines and vaccines.
Transfer of Contraceptive Prequalification From UNFPA
A core element of the update involves transferring prequalification duties for male and female condoms and intrauterine devices from the United Nations Population Fund to the WHO. Access to these quality-assured supplies supports sexual and reproductive health by preventing unintended pregnancies and lowering the transmission risks of HIV and other sexually transmitted infections. Previously, male circumcision devices underwent a separate evaluation process. Integrating them into the broader prequalification framework standardizes voluntary medical male circumcision services, which clinical data cited by the WHO show can reduce a man’s risk of acquiring HIV through heterosexual exposure by roughly 60 percent.
Integration of Artificial Intelligence in TB Screening
The programme now evaluates computer-aided detection software for tuberculosis screening, marking the inclusion of a digital health technology. CAD-TB software pairs digital chest X-rays with artificial intelligence to flag individuals who require further diagnostic testing. According to the WHO, the digital tool accelerates detection and treatment connections in high-burden settings where reliable screening methods are critical.
Did you know? An estimated 70% of countries report inadequate or weak regulatory systems for medicines and vaccines, facing even steeper hurdles when evaluating other health products.
Frequently Asked Questions About the Programme
What products are included in the expanded WHO prequalification programme?
The programme covers contraceptives such as male and female condoms and intrauterine devices, computer-aided detection software for tuberculosis screening, male circumcision devices, and in vitro diagnostics.
Why did the WHO expand its prequalification framework?
The expansion helps nations with limited regulatory capacity ensure that imported or procured medical devices meet international standards for safety, quality, and performance.
Who manages the prequalification for condoms and IUDs?
Responsibility for prequalifying male and female condoms and intrauterine devices transferred from the United Nations Population Fund to the World Health Organization under this initiative.