WP2 is on Policy, Laws and Regulations. In this WP, we will support the target countries to address the relevant policies and legislations influencing PV, including regulations for the pharmaceutical industry related to the provision of cumulative reports of safety and guidance for reporting for healthcare professionals. PAVIA will also address sustainability by focusing on several funding sources such as donor support, PV tax on pharmaceutical sales, market conform registration taxes and support through national taxes.
University of Benin (Nigeria) will coordinate and support efforts of NAFDAC, TDFA, FMHACA and MoH-S regarding their relevant policies and legislations to strengthen PV. Through these partners, high level engagement of the MoH in the respective countries will be arranged. We will ensure a systematic approach for
the development of a harmonised legislation on medicines regulation in African countries, thereby also supporting the African Union’s desire to promote local production of pharmaceuticals with a view to the protection of public health. To this end, we will use the African Union Model Law on Medical Products Regulation and
Harmonisation in Africa as a basis for all activities. AIGHD will support the development of sustainable business models having ample experience within building business cases in the field of vaccines for neglected infectious
Task 2.1 Develop a country specific regulatory framework to strengthen national PV system
Task 2.2 Work towards consistent implementation of all essential regulatory functions
Task 2.3 Provide the necessary documentations, guidelines and revisions to support implementation
Task 2.4 Develop country specific sustainability and financing models