EFPIA立场文件-优化营销授权续期以提高效率和可持续获取

EFPIA Position Paper Optimizing Marketing Authorization Renewals for Efficiency and Sustainable Access Date:March 2026 Executive Summary Currently, there is a highly divergent approach to the marketing authorization (MA) renewal processglobally, with requirements of varying complexity across countries. While many authorities still requiremarketing authorizations (MAs) to be renewed continuously after a defined period (usually every five Thecomplexity of international renewal requirements often leads to duplication of efforts,unnecessary administrative burden for both industry and regulators, and inefficiencies that can Thispaper recommendation that National Regulatory Agencies(NRAs)to simplify renewalrequirements and ultimately transition toward unlimited MAsto support more efficient oversight and Background Traditionally, companies must submit renewal applications—often every five years—to keep theirmarketing authorization valid.The intention behind repeated renewals is to ensure that a product’ssafety, quality, and efficacy continue to meet the standards established by NRAs through periodic However, over the past two decades, the regulatory systems haveevolved considerably. Today,comprehensive pharmacovigilance systems, GMP inspections, and post-approval change managementframeworks are operated to continuously ensure the quality, safety, and efficacy of marketed EFPIA Brussels OfficeNeo BuildingRue Montoyer 51,box 31000 BrusselsBelgiumTel: + 32 (0)2 626 25 55www.efpia.euinfo@efpia.eu become redundant since their objectives are now effectively achieved through strong post-marketingregulatory mechanisms. Current Renewal Practices After the initial MA, various post-marketing regulatory mechanisms—such as pharmacovigilanceactivities, GMP inspections, post-approval variations, and ongoing obligations—ensure continuous •Permanent MA:In countries such as the US, Canada, and Japan, the initial MA remains validindefinitely, and no renewal process is required.Although marketing authorizations are •Single renewal and reliance-based renewal:In jurisdictions such as Switzerland, an initialmarketing authorisation typically becomes indefinite following a first renewal—conductedfive years after the first issuance—without requiring a full re-assessment ofsafety, efficacyand quality dossier. Some authorities such as MHRA in the UK rely on assessments and •Auto-Renewal:In countries such as Singapore with amature post-marketing framework therenewal process is purely administrative and maintained through annual fees without dossiersubmission. Despite these advancements, many countries(>40)still require companies to resubmit unchangedModules 3including testing requirementsevery five years (and sometimes between 1-5 years). Thesepartial or full dossier resubmissions replicate data already reviewed and updated through ongoingpharmacovigilance reports and approved variations. This practice provides no additional benefit but Challenges with the Current System •Redundant Data and Document Collection:Rebuilding and resubmitting unchanged clinical,nonclinical, and quality data not only create a huge administrative burden for industry but also •ResourceDeviation:Regulators spend time on administrative reviews rather than on activitiesthat have safety implications, such as pharmacovigilance, GMP inspections, or emerging health •Supply Disruption:In some countries, companies cannot submit or implement variations toupdate safety or quality information until the renewal is approved resulting in constrainingsupply-chain flexibility. Long renewal review timelines contribute to an increase in the backlogof submission reviews,resulting in outdated information / renewal approvals. Unexpected EFPIA Brussels OfficeNeo BuildingRue Montoyer 51,box 31000 BrusselsBelgiumTel: + 32 (0)2 626 25 55www.efpia.euinfo@efpia.eu •Fragmented Global Landscape:Different expectations and renewal periods across countrieslead to complexity for submission management and supply planning. Marketing authorization In essence, the current renewal system has become misaligned with today’s continuous oversightthroughout the lifecycle of the products. Modernizing it is crucial to focus public health by ensuring Recommendations Enabled by a more efficient lifecycle oversight that ensures continuous product availability, EFPIArecommends regulators to adopt a, risk-based approach to the renewal process. The following A. Transitioning Toward Permanent Authorization or Administrative Renewal 1-Implement permanent MA or administrative renewals Regulators with established post-marketing oversight systems such as robust pharmacovigilance,risk-based GMP supervision, and post-approval change controls—may transition to permanentmarketing authorization or administrative renewal. or. These modelsreplace routine dossier 2-Introduce reliance mechanisms in renewal process Authorities can leverage decisions or assessments from trusted regulatory authorities or