WHO 预认证部门就美沙酮、丁丙诺啡（舌下）和纳洛酮发出预认证意向征集

News

22 May, 2026 - 00:12 (CEST)

Announcement

The 1st Invitation to manufacturers of medicinal products for treatment of substance use disorders to submit an application for product evaluation by prequalification has been issued based on a request from WHO’s Alcohol, Drugs and Addictive Behaviours (ADA) Team at the Department of Non-Communicable Diseases and Mental Health (NMH). 

Approximately 300 million people worldwide use psychoactive drugs at least once a year with approximately 60 million people engaged in non-medical opioid use. Opioids continue to be the group of substances with the highest contribution to severe drug-related harm, including fatal overdoses. While effective pharmacotherapy for treatment exists, the treatment gap remains very high and requires actions to strengthen access to evidence-based interventions.

With the aim of improving availability and access to treatment of opioid dependence and reducing the number of deaths from opioid overdose, the Guideline Development Group (GDG) reviewed the available evidence and decided to issue recommendations in favour of several pharmacological interventions for people at risk of overdose and those with opioid dependence. 

While work on the guidelines is ongoing, WHO has recently issued a rapid communication outlining key recommendations. The current EOI invites manufacturers of selected medicines—identified among the treatment options included in this rapid communication—to submit applications for prequalification, pending completion of the guideline, anticipated in late 2026 or early 2027.The current invitation includes the following medicines*:

-    Methadone
-    Buprenorphine (sublingual)
-    Naloxone

*details can be found in the EOI