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The key purpose of program is build the institutional and personnel capacities of NECs and the National Drug regulatory agency to provide efficient and effective pharmacovigilance oversight, clinical trial approval and monitoring and medicines registration.

The objectives of this proposal are:

1. To support NECs and NRAs’ development of institutional and personnel capacities to enable them to perform their national ethical oversight function to efficiently review clinical trial applications and monitor on-going studies.
2. To support NRAs’ development of institutional and personnel capacities to enable improved regulatory pathway activities directly related to clinical trials and registration of new medicinal products. This will also include strengthening the pharmacovigilance systems.
3. To increase awareness and promote active participation of stakeholders in clinical trials approval and monitoring and safe medicines use by promoting a web-based platform for engagement, information dissemination and reporting.