世界卫生组织全球智能药物警戒战略：摘要

WHOGlobal SmartPharmacovigilanceStrategy: synopsis Background When faced with competinghealthpriorities, countries will have to investtheir limited resourcesjudiciously, by focusingpharmacovigilance effortson priority productsandadoptingapproachesthat arerelevantto their settings, byrelying on the work ofother countries whenpossible andbuilding nationalcompetence for those activities that cannot be delegated. This is Smart Pharmacovigilance. AGlobalSmart PharmacovigilanceStrategyis proposed as an approach that can help establish robust,proactive,safety monitoringand risk managementsystems that leverageexisting infrastructure butconsider the specific constraints and requirements of the healthcare settings. The objective is to buildon thelearnings from the Smart Safety Surveillance (3S)pilot projects1, theGlobal Vaccine SafetyBlueprint (GVSB)2and the COVID-19 pandemicexperiences3, to developa comprehensive andsustainable safety monitoringand risk managementpractice as an integral part of healthcare andregulatory system, enabling quick,adequateand sustainableresponses to potential safety risks withprioritymedicinalproductsin all Member States. A key aspect of the ‘Smart’ approach lies in the factthat not all products would be monitored the same way, and not all countrieswouldneed to doeverything. Instead, the focuswouldbe on a development strategy that best serves the prioritypharmacovigilance needs of the country while utilizing the information and leveraging the resources inother countries, to mutual benefit. Four keyprinciplesunderpin thestrategy: 1)Previouspharmacovigilance efforts and lessons learnt; 2)risk-based(approach toprioritize)pharmacovigilance activities;3) work-sharing and reliance inpharmacovigilance;4)pharmacovigilanceas partof stepwise regulatory system strengthening efforts. 1)Previous pharmacovigilance efforts and lessonslearnt:Pharmacovigilancehas come a long waysince the establishment oftheWHOProgramme for International Drug Monitoring(PIDM)in1968, and it is important to learn from and build on previousaccomplishments. Successes canbe observed at national, regional, and global levels. Tailored approaches are taken in differentsettings according to assessed needs and functionality. 2)Risk-basedapproach andprioritization:This consists offocusing PV efforts on priority products:1)Products that are exclusive to their settings, introduced to address a disease of limited geographic prevalence,data for which will not be available or forthcoming from the rest of theworld;2)Products with limited clinical data, receiving accelerated approvalsfor several reasonsand to be introduced simultaneously in highincome-andlow-and middle-incomecountries(LMICs), with little global experience that LMICs can rely-on. 3)Work-sharing and Reliance:The overarching vision forthe WHO General Programme of Work(GPW14) is to promote, provide and protect the health and well-being of all people everywhere.This strategyrecognizes variation in health systems, some with fragile health systems on oneend ofthe spectrum and more mature health systems on the other end. It is proposed that thefocus and prioritization of PV consider available resources and regulatory system capacity.Theprinciples of work-sharing and reliance would be key considerations. 4)Pharmacovigilance as part of stepwise regulatory system strengthening efforts:Pharmacovigilanceneeds to be embedded into a regulatory framework for sustainability. Relevant legal frameworks empower regulatory agenciesin the implementation and oversight ofsafety monitoring and related activities. The WHO Global Benchmarking Tool (GBT)4helps tobenchmark and assess the maturity of an entirenationalregulatory system. It consists of a set ofindicators categorized into nine regulatory functions, including PV.Following a benchmarkingexercise, gaps or areas where the PV system can be improved are incorporated into aninstitutional development plan (IDP) providing a roadmap to stepwise system strengtheningapproach. In view of some of the common processes and requirements between medicines and vaccines’ safetysurveillance, the strategy advocates the use of data tools and methods, and regulatory frameworkacross the two product types. It promotes the use of existing networks and platforms such as the WHOProgramme for International Drug Monitoring (PIDM), the African Medicines Regulatory Harmonization(AMRH), South East Asia Regulatory Network (SEARN), Association of South East Asian Nations (ASEAN),the Regional Pharmacovigilance Network of the Americas and Caribbean Sub-regional Network(VigiCarib) , the Western Pacific Regional Alliance of National Regulatory Authorities and the Coalitionof Interested Parties (CIP), to name a few. Medicine and vaccine safety communication is necessary throughout the life cycle of a product and isaddressed as a cross-cutting component throughout the strategy. Methods to enhance communicationare provided. A few hypothetical scenarios of the introduct