WHO Launches First Prequalification Initiative for Opioid Dependence and Overdose Medications
The World Health Organization (WHO) has taken a significant step toward improving global access to treatment for opioid use disorders and overdose prevention by opening its first-ever call for manufacturers to submit medicines for evaluation under the WHO Prequalification Programme. The announcement, made on May 22, 2026, marks an important milestone in the organization’s efforts to strengthen access to safe, effective, and quality-assured medications for communities affected by substance use disorders worldwide.
Addressing a Growing Global Health Challenge
Substance use disorders continue to present a major public health challenge across the globe. Current estimates suggest that approximately 316 million people use psychoactive substances each year, with around 61 million individuals engaging in non-medical opioid use. Opioids remain one of the leading contributors to drug-related illness and death, accounting for a substantial portion of overdose fatalities and long-term health complications.
Despite the widespread impact of opioid dependence, access to evidence-based treatment remains limited in many countries. Millions of people who could benefit from treatment services are unable to obtain appropriate medications due to availability, affordability, regulatory barriers, or supply chain challenges.
WHO Invites Manufacturers to Participate
To help close this treatment gap, WHO is inviting pharmaceutical manufacturers to submit Expressions of Interest (EOIs) for selected medications used in opioid dependence treatment and overdose response.
The initial invitation includes several essential medicines recognized as critical tools in reducing opioid-related harm:
- Methadone for opioid dependence treatment
- Buprenorphine (sublingual formulations) for opioid dependence treatment
- Naloxone for emergency opioid overdose reversal
Through the prequalification process, manufacturers can have their products independently assessed against WHO standards for quality, safety, and effectiveness. Medicines that successfully meet these requirements may become more accessible to countries, healthcare systems, and international procurement programs seeking trusted treatment options.
Expanding Access to Quality-Assured Medicines
The WHO Prequalification Programme plays an important role in global health by evaluating medicines and health products to ensure they meet internationally recognized standards. Many governments, humanitarian organizations, and international purchasing agencies rely on prequalified products when sourcing medications for public health programs.
By extending the program to include medications for opioid dependence and overdose management, WHO aims to:
- Increase the availability of trusted treatment options worldwide
- Improve access to evidence-based care for people living with opioid use disorder
- Support national healthcare systems in expanding treatment services
- Strengthen overdose prevention efforts through broader access to Naloxone
- Encourage manufacturers to invest in producing high-quality addiction treatment medications
The initiative is particularly important for low- and middle-income countries, where access to these medications may be inconsistent or limited despite growing need.
Supporting Evidence-Based Treatment and Overdose Prevention
Medications such as methadone and buprenorphine are widely recognized as effective treatments for opioid dependence. These therapies can help reduce illicit opioid use, lower overdose risk, improve quality of life, and support long-term recovery.
Similarly, Naloxone remains one of the most important tools for responding to opioid overdoses. When administered quickly, Naloxone can temporarily reverse opioid-induced respiratory depression and provide critical time for emergency medical care to arrive. Expanding access to this medication has become a cornerstone of overdose prevention strategies worldwide.
As increasingly potent synthetic opioids continue to emerge in drug supplies across many regions, ensuring broad access to both treatment medications and overdose reversal tools remains a public health priority.
Connection to Updated WHO Guidelines
The prequalification initiative also aligns with WHO’s ongoing work to update its global guidance on opioid dependence treatment and overdose prevention.
The organization is currently revising its recommendations to reflect the latest scientific evidence and best practices. The updated guidelines are expected to be finalized and published in late 2026 or early 2027.
These forthcoming recommendations are anticipated to provide additional guidance on expanding access to treatment, improving overdose response systems, and supporting countries in implementing evidence-based approaches to opioid-related health challenges.
Looking Ahead
WHO’s decision to include opioid dependence and overdose medications in its Prequalification Programme represents an important advancement in global efforts to address substance use disorders. By encouraging manufacturers to submit products for evaluation and helping countries identify quality-assured medicines, the initiative has the potential to improve treatment access and strengthen overdose prevention efforts around the world.
As the opioid crisis continues to evolve, expanding access to proven medications such as methadone, buprenorphine, and Naloxone will remain a critical component of reducing overdose deaths, supporting recovery, and improving public health outcomes on a global scale.
Source: WHO