Short Update WHO Essential Medicines and Health products IPC Meeting 4 to 6 June 2014

Essential Medicines and Health Products Department (EMP) October 2013 Office of the Director Kees de Joncheere Policy, Access and Use (PAU) Gilles Forte National policies on medicines & on technologies; regional & country support Indicators & tools for pharmaceutical sector monitoring & assessment Transparency & good governance in medicines Supply management systems Medicines pricing policies Selection of essential medicines International control of psychotropic and narcotic substances: evaluation of abuse liability (of dependence-producing drugs) Access to controlled medicines Rational use and anti-microbial resistance Public Health, Innovation and Intellectual Property (PHI) Zafar Mirza Global Strategy & Plan of Action on Public Health, Innovation & Intellectual Property Management of intellectual Property for Public Health Financing and Coordination for health research & development Local production for improvement in access Transfer of technology for vaccine & bio- therapeutics production Health technology innovation Global Platform for Innovation & Access Regulation of Medicines and other Health Technologies (RHT) Lembit Rägo Regulatory systems strengthening (including blood products) Norms/standards (including nomenclature) Quality assurance of products Safety /pharmacovigilance Prequalification of medicines, vaccines, diagnostics & medical devices Technologies Standards and Norms (TSN) David Wood Global standards/nomenclature - Biological Standardization - Pharmaceutical Preparations - International Pharmacopeia - International Nonproprietary Names (INNs) Global measurement standards - biotherapeutics; blood products; in vitro diagnostic devices; vaccines Prequalification Team (PQT) Lembit Rägo (Acting) Prequalification of medicines, vaccines, diagnostics & medical devices: Dossier assessments Inspection PQ of medicines QC laboratories Laboratory testing Scientific advice Technical assistance Safety and Vigilance (SAV) Clive Ondari Medicines classification & assignment of daily doses (ATC/DDD) Surveillance/monitoring, including for SSFFC medical products Capacity building & coordination of global response to health/ safety events Regulatory Systems Strengthening (RSS) Nora Dellepiane de Rey Tolve Regulatory networks NRA assessment Capacity building Harmonization initiatives ICDRA support

Policy & Governance EC/ACP/WHO Partnership for strengthening pharmaceutical systems and improving access to medicines in 15 countries in Africa Muskoka Initiative in 7 countries in Africa for improving access and use of EM for mothers and children Mapping of barriers to access to NCD medicines and proposed interventions to achieve 80% availability MeTA and GGM programmes ongoing in countries EMP Portal upgrade, 5000 WHO & non WHO publications on medicines & health technologies Preparation of the 2015 global country profiles survey

Access and use 36th ECDD – 16 to 20 June - evaluation of 26 NPS Preparation of the 20th EC on Essential medicines in opportunity to improve EML updating process; Use of HTA in decision making UNcoLSC programmes for improving access to medicines for mother and child in countries in Africa development of Global Action Plan on AMR - responsible use of antibiotics Policy discussions on local production of medicines / medical products ( African Union, UNIDO, UNAIDS)

Norms and standards ECBS and ECSPP reports were presented to the EB; the e-versions will be posted soon (for ECSPP should be this week)(ECSPP has 8 new and revised guidelines, plus more than 20 monographs for inclusion in the PhInt) MQAS (including its revised Appendix 6 product questionnaire and Appendix 13 model inspection report and the related aide-memoire for inspection good example for inter-agency collaboration, published in the ECSPP report 3 rd International Meeting of World Pharmacopoeias took place in London, good progress with GPhP aiming at convergence, three further meetings scheduled, co-hosted by PhEur, USP, ChP Biosimilars - INN new policy and update of WHO guidance in progress + resolution in WHA

Safety National PV centres and the UMC Piloting an algorithm for the detection of SSFFC from PV data Working towards a consolidated plan for the harmonization of PV activities in the APEC and EAC regions Developing proof of concept of active surveillance methods, to complement spontaneous reporting systems working with low and middle income countries on an improved signal detection process, to detect signals relevant to these settings (quality of products, quality of care, availability of medicines etc)

PQ and regulatory strengthening Reorganization of functions in progress NRA assessment Funding model Starting with expanding products range : NTD, antivenoms, … First Nigerian manufacturer compliant with WHO GMP ICDRA – August 24-29, Rio de Janeiro International harmonization efforts (ICDRA, ICMRA, IPRF, PANDRH, AMRH. ASEAN, APEC, EMDRAC ….)