Mary Njeri PV PMS Pharmacy and Poisons BoardKenya

Mary Njeri PV & PMS Pharmacy and Poisons Board-Kenya

• Safety policy and legal frameworks for PV exist in five Partner State, only 4 NMRAs (United Republic of Tanzania (mainland), Republic of Kenya, Rwanda and Uganda) have safety regulation on PV for health professionals however only Uganda has a legal provision for safety monitoring by pharmaceutical industry • All the EAC Partner States have basic structures for coordination of PV activities, however the systems and structures differ. • All the six NMRAs are members of the WHO Program for International Drug Monitoring. • PV guidelines, advisory committees, data collection tools/forms, designated staff, all exist in the NMRAs. • Both Passive and Active PV methods are used within the partner states.

Quality Control Laboratories • Four World Health Organization (WHO) prequalified –medquality control laboratories exist in the region, PV in Public Health Programs • Existing policy framework and basic structures are basically in malaria , HIV and immunization programs. • Variable e�ort to collect and aggregate adverse events in PHPs and to share the information with national PV centers Post-Market Surveillance activities • Only TFDA has PMS entrenched in their law

EAC PHARMACOVIGILANCE ACTIVITIES

• The 9 th Health Sectoral Council meeting in April 2014 directed the EAC Secretariat to officially constitute a Regional EWG of Experts on PV and PMS to develop a fundable proposal. (EAC/9 SCM/Health/Decision 058) • A Regional EWG of Experts on PV and PMS was constituted in 2014 • The Steering Committee for the EAC- MRH serves as Steering Committee for PV & PMS activities

EAC Sectoral Council of Ministers of Health AMRH Partners EAC Sectoral Committee on Health WHO, MSH SWISSMEDIC, • • Advocacy • Coordination Work Plans • Regional Annual • Consolidated Budget & procurement plan • Interim Finance Reports • Annual Audit Project Steering Committee • Guidelines for harmonization • TA EAC Project Coordination Team Technical Working Group(s) • Nomination of experts • Participation in consultations NMRA 1 TFDA +MUHAS -MER NMRA 2 ZFDB NEPAD Agency NMRA 3 PPB + UON PV • • NMRA Annual Work Plans Annual Budgets Procurement Plans Quarterly performance Reports NMRA 4 NDA +MUK GMP NMRA 5 PTF NMRA 6 DPML 8

• Membership: Total 12 members drawn from the PV and PMS departments/Units of the six NMRAs • Key Mandate of the EWG Facilitate development & implementation of harmonized PV and PMS technical requirements and guidelines in the EAC ØFacilitate implementation of a regional harmonized system for detecting, assessing, preventing and responding to adverse events and other issues related to health products Ø

Activities carried out by the EWG • Weeks Fellowship training in WHO Collaborating Centre Ghana: • 6 participants, one from each of the 6 EAC Partner States NMRAs; 21 st July to 15 th August, 2014 • Meetings for the EWG: 7 VCs and 4 Face to face meeting since Feb 2014 • Participation in the WHO led Clinical Trials Protocol review for Ebola Vaccine in Feb 2015 • Draft of proposal to mobilize funds for harmonization of PV & PMS activities in EAC Partner States –NMRAs; under review by WHO

• Draft of standard/harmonized tools to assess PV systems in EAC partner states 2015 -2016 ØThese were adapted from WHO PV Indicators and MSH/Indicator Based Pharmacovigilance Assessment Tool • Capacity building of EWG TOT was done in June 2016 • Draft of PV assessment plan(s) for EAC Partner States • Capacity building plan of EAC partner states for application of PV assessment tools • A separate PMS proposal was developed to look at Establishment of a regional Quality Infrastructure for the pharmaceutical sector

• Proposal Title: • Project on Harmonization and Strengthening of Pharmacovigilance Systems of Medicines, Health Products and Technologies in East African Partner States • Goal: • To promote patient safety through harmonization and strengthening Pharmacovigilance systems in the EAC partner states.

• • • Increased access to new essential medicines; and molecules requires additional efforts The increasing burden of adverse events from poor quality products, adverse drug reactions (ADRs), and medication errors Absence of actual estimates of the burden of substandard, spurious , falsely labelled, falsified and counterfeit (SSFFC) products within the EAC Partner States Inadequate resources and capacity at NMRAs to undertake PV & PMS activities Lack of PV and PMS information data base to support policy formulation for the region

The specific objectives (3): • Objective 1: To develop and implement harmonized PV requirements, guidelines, procedures and practices for the regulation of medicines, health products and technologies in the EAC region. • Objective 2: To build and strengthen institutional capacity on Pharmacovigilance in the EAC Partner States. • Objective 3: To support partnership and decision making through appropriate technology and information sharing on product safety.

• PV Activities Ø WORLD BANK Ø WHO Ø USAID/SIAPS • PMS Activities The Physikalisch-Technische Bundesanstalt (PTB), the National Metrology institute Ø USP/PQM Ø

• Conduct gap analysis for targeted PV systems strengthening. • Partner States to harmonise and strengthened pharmacovigilance systems for Medicines, Health Products and Technologies; (Harmonized tools, guidelines and legal policy framework on PV &PMS) • The EAC Secretariat and Partner States to mobilize resources support implementation of the proposal; from National budgets, development and Implementing partners [AMRH, USAID/SIAPS and other Partners] • EAC Secretariat to expedite formal administrative arrangements with interested Development Partners with well defined scope, roles and responsibilities to support the implementation.