Africa and Asia Office
Slide 1: Key Priority Issues:
- To develop and strengthen closer working relationships with U.S. FDA’s counterpart agencies, appropriate officials in the Ministries of Health and Agriculture, U.S. Agencies in-country and relevant stakeholders to develop an accurate knowledge base of how our counterpart agencies operate and conduct day-to-day business.
- To strengthen relationships with confidential partners, expand regular contact with active non-confidential partners to leverage our ability to obtain and share information in a proactive manner that supports consumer protection and public health.
Slide 2: Key FY2010 Focus:
- Support the agency mandate to assist Drug Regulatory Authorities (DRA) in PEPFAR countries in drug registration and regulatory oversight activities.
- Determine providers of technical assistance/capacity building to the region.
- Link to and leverage multilateral, NGO, and SCMS activities supporting DRAs.
- Work more closely with the WHO Prequalification Unit to leverage the exchange of information and inspection reports to (1) support the manufacture and availability of quality ARVs for the PEPFAR program; and (2) share proposed inspection sites.
- Enhance U.S. FDA’s presence and reputation as a strong science-based regulatory partner for the developing and developed countries in Africa and Asia.