Washington, DC. March 22, 2017. PAHO engaged on a project with member countries to develop the Regulatory Exchange Portal secure (REPs), an international, collaborative IT (information technology) secured portal for sharing non-public and/or confidential regulatory information about medical products amongst national regulatory authorities. This virtual platform -hosted by PAHO- will ensure effective, traceable, and secure information exchanges fostering cooperative work and trust building across agencies. It will be scalable to accommodate existing and future regulatory initiatives while conforming to stringent data transmission security standards.
The first phase of REPs will serve the needs of the Medical Device Single Audit Program (MDSAP) initiative. MDSAP is a multi-country collaboration (currently formed by Australia, Brazil, Canada, and Japan) to improve regulation of medical devices with the participation of National Regulatory Authorities in the Region, and in other WHO Regions. This global and collaborative approach to regulating medical products will enhance oversight and the safety of medical devices while avoiding duplications of efforts and improving efficiencies of the regulatory processes.
During this phase, REPs will focus on the exchange of audit reports in the context of the MDSAP as the first initiative to be leveraged. This first phase is meant to go live in July 2017. The second phase will include other functionalities for MDSAP and another module (originally named PRAISec) for exchanging regulatory documents outside the MDSAP Program, such as Good Manufacturing Practices Reports for Drugs and other Health Technologies, Marketing Authorizations documents, amongst others. This phase is planned to go live in September 2017.
The platform is conceived on a modular system and will be developed to accommodate future initiatives with specific workflows and functionalities. REPs will become the first multi-country instrument of its kind and will embody the conjoint efforts of regulatory authorities that are contributing their technical and financial resources.
REPs will be able to create audit logs that can help PAHO to monitor and evaluate the impact of the tool and of the information exchanged. Thus, it will become a powerful tool for quantifying the frequency and impact of these exchanges.
Access to safe, efficacious and quality-assured medical products constitutes one of the pillars of health systems. The growing complexities of the medical products that reach the market represent a challenge for effective regulation, even for mature regulatory systems. Hence, cross-country cooperation is required and exchange of information is a key component of that cooperation.
PAHO Member States have committed to improving regulatory capacities in the Region with the Directing Council Resolution CD50.R9 (2010) "Strengthening National Regulatory Authorities for Medicines and Biologicals," and more recently WHA Resolution 67.20 (2014), "Regulatory system strengthening for medical products".The Region of the Americas will benefit from this initiative and the Platform will be open to the use of the countries of the Region, as part of the activities to strengthen regulatory capacities.