The 3rd African Regulatory Forum on Medical Diagnostics

Summary of Recommendations from the 3rd African Regulatory Forum on Medical Diagnostics

  • PAHWP confirmed its commitment to continue working within the framework of AU-NEPAD agency which has experience in African Medicines Harmonization program.
  • PAHWP propose formation of a steering committee from heads of national regulatory authorities and national Laboratories to forge ahead PAHWP agenda and guide on the future of PAHWP. PAHWP therefore requests AU NEPAD to convene a meeting of Heads of Regulatory Authorities to effect the formation of steering committee.
  • PAHWP recommends countries adopt a stepwise approach to harmonized regulation of medical devices and in vitro diagnostics and urge countries to identify 1-3 key priority areas for implementation in 2015.
  • PAHWP requests AU-NEPAD to take up the role of monitoring implementation of PAHWP activities at the continental level.
  • The PAHWP, coordinated by the AU NEPAD agency, welcomes the Diagnostics Access Initiative and will work with partner states, WHO, LSHTM, ASLM and any other partners to support harmonized regulatory guidance to ensure the quality of diagnostics.
  • PAHWP under the coordination of AU NEPAD will establish a resource and learning center to promote pooling and sharing of resources and capacity through e learning from a virtual campus.

Presentations from the 3rd Forum

The meeting was primarily a Forum for discussion and sharing of ideas, view the meeting's agenda for an overview of the topics covered.

Presentations from the preceding PAHWP TWG meeting

PMS Activities Patience Dabula, NHLS

Update on MD-SAP and educational materials

IVD Regulatory Framework
Presentations from the 3rd Forum

Pan-African Harmonization Working Party (PAHWP) on Medical Devices and Diagnostics Infrastructure and progress to date Paul Tanui, AU-NEPAD Agency

Diagnostics Access Initiative Rosanna Peeling

ALADDiV Interegional Collaboration Sarvashni Moodliar, NHLS

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Improving Access to Affordable Diagnostics