Overview
The World Health Organization (WHO) established the Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce in 1969. As one of the earliest instruments promoting regulatory reliance, the Scheme was designed to support Member States in ensuring the quality of medicines circulating in the global market. Over the years, it has undergone several amendments to align with evolving regulatory frameworks and global health needs.
This publication presents an overview of the WHO Certification Scheme, detailing its objectives, historical development, and role within the broader regulatory ecosystem. It examines the Scheme’s strengths and limitations, and offers recommendations for its effective use alongside other regulatory tools. The publication also incorporates insights from National Regulatory Authorities across various WHO regions, as well as perspectives from industry representatives, providing a well-rounded view of the Scheme’s implementation and impact.