2025年年度监管GMP/GDP检查调查数据

Annual Regulatory GMP/GDP InspectionSurvey 2025 Data Author: MQEG Date: 11. May 2026 Version: 1 EFPIA’SANNUAL INSPECTION SURVEY–SUMMARY ON THE 2025 DATA Key messages: Inspection schedules start to turninspection reliance into routine practice Foreign inspections aredecreasing, suggestingregulators are relying more oneach other’s inspections andreducing duplication Inspectorates to collaborateusing the reliance toolbox e.g.,PIC/Ssystematically, facilitatingestablished trade relationshipsand extending recognition Take aways Calls to action Inspections are becomingmore focused and demanding,with greater emphasis onsystems, risk-based approaches,and targeted questions ratherthan simple procedure checks Advocate for bettercooperation onscheduling,aligned scope, common reportformats, and broaderrecognition of trustedauthorities, especially PIC/Sparticipating authorities Operational challenges remain,including differinginterpretations and formats,while unannounced inspectionsmainly affect logistics Companies to proactivelyidentify potential duplicatedinspectionsituations andformally request reliance Background and history History The annual inspection survey was initiated in 2003 by the research-basedindustry association EFPIA Scope Regulatory GMP/GDP inspections–all modesInside and outside the own borders (domestic and foreign*)Manufacturing sites and commercial affiliates worldwideNotified Bodies certifications for devices used in Medicinal Products Intent Monitor trends and new focus areasPromote reliance optimizing the use of inspection resourcesMaterialise thebenefits of PIC/S membership and MRAs EFPIA’SANNUAL INSPECTION SURVEY-DATA Trends on inspection modes Not relevant currently EFPIA’SANNUAL INSPECTION SURVEY-DATA Reliance appears to materialise 25%lessinspectionscomparedtothedata2015-2019 EFPIA’SANNUAL INSPECTION SURVEY2025 Did we cross the pivot point for the number of foreigninspections? EFPIA’SANNUAL INSPECTION SURVEY-OUTCOME Outcome of the data for inspections at manufacturing sites •Onsite inspections are the norm; ‘remote’ inspection remain as back up option•The implementation of GMP Annex 1did not increase the number ofinspections at sterile manufacturing sites of medicinal products nor APIs Inspectionprocess •Continued supply: No site reported interruption of supply as of inspections•‘For cause’: Numbers are decreasing & still result in no interruption of supply•Announced or unannouncedinspections yieldsimilaroutcomes Outcome ofinspections •Unannounced inspectionsare mostly performed by China and the US-FDA*1•Same durationfor domestic and foreign inspections this year*2•Inspections reported as ‘PAI’are performed by many inspectorates(JP, EU,US,KR) Inspectionpractices Foreigninspections •Positive indicator on reliance: Number of reported inspections declined•1sttime in 23 years: no new country reported to perform foreign inspections EFPIA’SANNUAL INSPECTION SURVEY-2025 DATA What do the data tell us on foreign inspections?Overall trending down EFPIA’SANNUAL INSPECTION SURVEY-2025 DATA Number of foreign inspections at manufacturing sites(EU and EAEU each as one entity; all inspection types and modes) EFPIA’SANNUAL INSPECTION SURVEY-DATA Number of foreign inspections at manufacturing sites byregion of the inspectorate is less duplicative FOREIGN INSPECTIONS AT MANUFACTURING SITES Locations of manufacturing facilities hostingforeigninspections Thelocation,whereconductingforeigninspections,demonstratethatresearch-basedmanufacturersaremainlybasedinEU/EEA,USA,andSingapore(>75%) MANUFACTURING SITES WITH GLOBAL SUPPLY Indication on locations of manufacturing facilities ofresearch-based manufacturers forglobalsupply 12Thelocationforglobalsupply,whereinspectionsareperformedinEU/EEA,US,Singapore,andChina(>75%)12 MANUFACTURING SITES WITH LOCAL SUPPLY Indication on locations of manufacturing facilities ofresearch-based manufacturers forlocalsupply Thelocationforlocalsupply,whereinspectionsareperformedinChina,EU/EEA,Pakistan,andBrazil(>75%) INSPECTIONS AT MANUFACTURING SITES–PAI Inspectorates performing inspection prior to approval* Furtheropportunitiesforcollaborationandreliance Inspections reported as ‘PAI’* are performed by many inspectorates * Note: This also includes new facilities approval inspections see alsoCoordinating GMP inspections for centrallyauthorised products, EC & EMA, Compilation of Union Procedures, 1 January 2025 EFPIA’SANNUAL INSPECTION SURVEY-MRA Progress on MRAs Positive effect onimplementedreliance as of theMRA EU-US Opportunities for allMRAs to build on Routine andpreapprovalinspections Vaccines, plasma derived products, ATMP/CGT, and on medical devices /combination products Additionalchallengesremaining Legal interpretations of terminologiese.g., ‘PAI’, ‘GMP-certificate’, ATMPs / CGTs, oligonucleotides OPPORTUNITIES FOR COUNTRIES WITH PIC/S PARTICIPATING AUTHORITIES Driving sustainability through inspection prac