In a landmark collaboration, WHO with the Pan American Health Organization (PAHO) launched the first Quality Management Systems (QMS) workshop for national regulatory authorities (NRAs) in the Americas. This marks a significant step forward in strengthening regulatory systems to ensure equitable access to safe, effective and quality medical products—a fundamental component of public health.
Uniting to overcome challenges
Recognizing that robust regulatory systems are crucial for health security, WHO and PAHO have been instrumental in enhancing these across the region. Inspired by the WHA67.20 on 'Regulatory system strengthening for medical products' (24 May 2014) and strategic objectives outlined in PAHO's resolution CSP30.R12, which emphasizes the need to strengthen governance, transparency, and harmonization within regulatory systems, the workshop aimed to align regional efforts with these standards.
The event featured a detailed overview of available WHO QMS guidelines, particularly Annex 5 and Annex 13, from WHO Technical Report Series 1025 and its associated examples and practices. These guidelines serve as the cornerstone of efforts to enhance regulatory capacities, ensuring that NRAs are well-equipped to manage and improve health product quality. By merging their efforts, WHO and PAHO have reinforced their commitment to supporting NRAs through sustainable policies and the promotion of regulatory harmonization and convergence.
A milestone event
The four-day workshop was held in La Antigua, Guatemala, with support from the Pandemic Influenza Preparedness Framework Partnership Contribution. It served as a platform for sharing experiences and best practices among the NRAs of twelve countries: Belize, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Guyana, Honduras, Jamaica, Nicaragua, Paraguay, and the Bolivarian Republic of Venezuela.
As the first of its kind in the region, it focused not only on introducing WHO's established QMS guidelines but also on fostering an environment of mutual learning and support. The event highlighted the critical role of collaborative efforts in overcoming common regulatory challenges.
Workshop dynamics and impact
Participants engaged in a comprehensive agenda that covered the essentials of QMS implementation within NRAs. The sessions included presentations on the status of QMS implementation by each country, hands-on activities for identifying and addressing system gaps, and discussions on the cost of quality (an appraisal of resource use) and success stories. This proactive approach facilitated a deep dive into the practical aspects of QMS, empowering participants with the knowledge and tools to enhance their regulatory practices.
The workshop also established vital communication and support channels among the NRAs, which are essential for ongoing collaboration and assistance. By the end, attendees had developed actionable plans to integrate and enhance QMS within their respective authorities, showcasing the practical benefits of the knowledge and strategies shared.
Importance of enhancing regulatory capacities
The success of this inaugural workshop exemplifies the strategic impact of targeted investments in health systems strengthening. By enhancing regulatory capacities, these activities are contributing to a more robust infrastructure capable of swiftly and effectively managing health emergencies, such as influenza pandemics. This workshop not only fostered essential skills and cooperation among participants but also demonstrated a sustainable model for ongoing improvement in public health across the Americas. The long-term benefits of such investments ensure a healthier future, underpinned by resilient and responsive health systems.
Looking ahead
The success of this first regional workshop sets the stage for future initiatives, with plans to extend these efforts to more countries in the Americas and the Caribbean. WHO and PAHO are committed to maintaining this momentum, ensuring that the foundations laid will continue to support the enhancement of NRA capacities and, ultimately, improve global health outcomes.
