EU GMP

EMA updates batch-number guidance for parallel-traded medicinal products

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EMA updated its GMP/GDP Q&A on 21 October 2026 concerning batch numbers on medicinal products relabelled or repacked for parallel trade. The Q&A states that applicable national legislation or guidance should be followed. Where none exists, the outer packaging should carry one batch number allocated by the parallel trader, ideally combining the original batch number with a unique repackaging or relabelling code. Traceability between original and additional numbers must be documented. If separate numbers are used, both must appear in recall information. A completely different parallel-trader batch number is strongly discouraged and requires justification and supervisory-authority authorisation.

EMA Announces First Bilateral Meeting with APIC

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EMA announced its first bilateral meeting with the Active Pharmaceutical Ingredients Committee (APIC), organised within EMA’s annual bilateral meetings with industry stakeholder organisations. The meeting is scheduled for 2 September 2026 from 15:30 to 17:30 CEST at EMA in Amsterdam, the Netherlands. Its stated purpose is to exchange views and promote dialogue on topics of common interest. Participation is by invitation only. The page lists an agenda, first published on 31 July 2026 and updated on 23 September 2026, and a highlights report, reference EMA/199326/2026, first published on 23 September 2026.

EMA reports on international API inspection programme, 2017–2024

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EMA’s report reviews the International API Inspection Programme from 2017 to 2024. Across 13 participating authorities, information was shared on 936 inspected sites and 1,684 inspections, approximately 50% more inspections than in the previous period. Of the sites, 644 (69%) were of shared interest; inspection reliance was reported for 107 sites. Authorities conducted 91 remote inspections, while 27 joint inspections covered 25 sites. Duplicate inspections affected 32% of sites and were more frequent following non-compliant outcomes. The report identifies legal, confidentiality, language, technical and resource barriers to report sharing and centralised data exchange. It recommends timelier information sharing, improved report usability, stronger reliance practices and action on duplication.

Revised procedure for coordinating GMP inspections of centrally authorised products

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Version 3 of the guideline, adopted in April 2026 and entering into force on 10 September 2026, describes EMA coordination of GMP inspections conducted by EEA competent authorities for centrally authorised products. It covers pre-approval inspections, for-cause inspections and routine risk-based re-inspections, including inspection triggers, authority selection, preparation, site contacts and report submission through IRIS. The revision clarifies that, where a Supporting Authority is unnecessary, one Authority may perform both leading and supporting roles. Applicants should identify proposed manufacturing, testing and batch-release sites before submission, and all listed sites should be inspection-ready and compliant with EU or equivalent GMP from submission.

EMA Guidance on Implementing Shortage Prevention Plans

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EMA issued guidance describing how marketing authorisation holders should establish, maintain and update Shortage Prevention Plans for prescription-only human medicines in EU/EEA countries. Plans may group products sharing a supply chain, provided product-level minimum data can be supplied within two days of a request. The guidance sets out product information, patient-impact assessment, supply-chain mapping, shortage history, risk classification and proportionate management measures. It also identifies additional crisis-related information for listed critical medicines, including production and supply capacity, alternative sites and minimum stock levels. Plans should be updated after relevant changes and may form part of annual product quality review.