Sixteenth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines

This meeting continues the series of regular exchanges between regulators and representatives of industry stakeholder organisations, aiming to foster constructive dialogue on both general updates and focused discussions to support continuous improvement.
EventHumanQuality of medicines

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Date

, -

Plats

Online
European Medicines Agency, Amsterdam, the Netherlands

Event summary

This session focuses on:

  • implementation of the New Pharmaceutical Legislation (NPL)
  • application of the classification guideline on variations

Updates are provided on:

  • centralised procedure topics, including the revamp of the assessment report (AR)
  • submission predictability
  • pre-submission interactions (PreSIG)

The meeting also addresses the roll-out of electronic product information (ePI) for vaccines planned for Q4 2026, as well as the post-authorisation changes reliance pilot.

Documents

Agenda - 16th meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines

Draft Reference Number: EMA/116340/2026

English (EN) (125.25 KB - PDF)

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Highlight report - 16th meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines

English (EN) (219.14 KB - PDF)

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Presentation - Implementation of the New Pharmaceutical Legislation (NPL) (M. Fanari; M. Vogl; Z. Hanaizi; F. Day; A. Spinei, EMA)

English (EN) (342.9 KB - PDF)

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Presentation - Submission predictability and revamp pilot (F. Day, EMA)

English (EN) (1.91 MB - PDF)

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Presentation - Revamp update (C. Pothet, EMA)

English (EN) (1.58 MB - PDF)

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Presentation - Pre-Submission Interactions Group (PreSIG) - Proposal to pilot a revised pre-submission interaction model (T.Castelnovo, EMA)

English (EN) (411.9 KB - PDF)

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Presentation - ePI update: roadmap and next steps (E.Scanlan, EMA)

English (EN) (578.5 KB - PDF)

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Presentation - Using EMA assessments for reliance in post-approval changes (V.Palmi, EMA)

English (EN) (685.5 KB - PDF)

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Presentation - Update on digitalisation initiatives affecting centralised procedure submissions (M. Duta-Mare; K. Puusaari; S. Griniene, EMA)

English (EN) (564.87 KB - PDF)

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