The World Health Organization (WHO) has long been dedicated to ensuring the quality, safety, and efficacy of medicines and health products globally. A critical aspect of this mission is the quality of starting materials, such as active pharmaceutical ingredients (APIs) and excipients, used in pharmaceutical manufacturing.
Since the tragic diethylene glycol poisoning in 1937, regulatory frameworks have evolved to strengthen oversight and protect public health. One significant mechanism introduced was the Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce (CPP scheme), which has facilitated global information exchange since 1969.
However, the quality of starting materials remains a concern. The WHO Pharmaceutical Starting Materials Certification Scheme (SMACS), introduced in 2003, aimed to address this but has yet to be fully operationalized. Recent incidents of contamination and the increasing complexity of supply chains underscore the need to revisit SMACS.
In this context, WHO’s Regulatory Convergence and Networks (RCN), Incidents and Substandard & Falsified Medical Products (ISF), Regulatory System Strengthening (RSS), and Norms and Standard for Pharmaceuticals (NSP) teams will facilitate this consultative workshop to discuss the way forward.
Main Objective
Reassess SMACS and explore its potential to enhance the quality of medicines in international trade. This workshop will gather stakeholder perspectives and discuss the path forward for SMACS implementation.
Expected Outcomes
A clear understanding of SMACS and its benefits.
Identification of reasons for the non-implementation of SMACS.
Consensus on the implementation of SMACS with commitment from participating countries.
Recommendations from stakeholders to support the roadmap for implementation.
The agenda includes speakers from National Regulatory Authorities from all WHO regions, UNODC, regional organizations and industry representatives.
This is a crucial discussion to ensure patient safety and protect populations worldwide. The way forward is to enhance regulatory reliance and global cooperation to prevent tragedies related to substandard and falsified medicines.