Upcoming EMA committee meetings (CHMP, PRAC, CAT, PDCO, COMP), EU legislation milestones, MDR/IVDR and EUDAMED deadlines, guideline effective dates and consultation deadlines, each linked to its official source.
PRAC plenary: safety signals, PSUSA outcomes, RMPs and referrals are discussed. MAHs should check the agenda for their substances and prepare for signal recommendations that may require label updates.
End of the 12-month transition for registering legacy devices and MDR/IVDR devices already on the market before 28 May 2026 in the EUDAMED UDI/Device module. Manufacturers should complete outstanding device registrations now.
COMP plenary: orphan designation opinions and orphan maintenance reviews at MA. Relevant for sponsors of rare-disease products.
CAT plenary on advanced therapy medicinal products (ATMPs): draft opinions and ATMP classifications. Relevant mainly for gene, cell and tissue therapy developers.
CHMP plenary: new marketing authorisation opinions, extensions of indication and SmPC changes are adopted. MAHs with pending procedures should watch the highlights published at the end of the week.
PDCO plenary: paediatric investigation plans (PIPs), waivers and compliance checks are decided. Developers with PIP procedures should align submission timetables.
Directly relevant to PV teams: sets data-quality expectations for collecting, managing and submitting ICSRs. MAHs and QPPVs should review and comment.
Veterinary MAHs and PV teams can comment on revised veterinary signal management rules.
Veterinary applicants can comment on user-safety assessment requirements.
Veterinary MAHs can comment on planned SPC wording rules for antimicrobials.
Developers of oral medicines can comment on how GI interactions (e.g. food, acid reducers) should be investigated.
PRAC plenary: safety signals, PSUSA outcomes, RMPs and referrals are discussed. MAHs should check the agenda for their substances and prepare for signal recommendations that may require label updates.
Herbal MAHs can comment on how interactions of herbal medicinal products should be investigated.
The GCP Annex 2 (decentralised, pragmatic and real-world-data elements of clinical trials) applies in the EU. Sponsors and CROs should update SOPs and trial oversight plans.
COMP plenary: orphan designation opinions and orphan maintenance reviews at MA. Relevant for sponsors of rare-disease products.
CAT plenary on advanced therapy medicinal products (ATMPs): draft opinions and ATMP classifications. Relevant mainly for gene, cell and tissue therapy developers.
CHMP plenary: new marketing authorisation opinions, extensions of indication and SmPC changes are adopted. MAHs with pending procedures should watch the highlights published at the end of the week.
PDCO plenary: paediatric investigation plans (PIPs), waivers and compliance checks are decided. Developers with PIP procedures should align submission timetables.
Sponsors running platform trials can comment on methodological expectations for confirmatory evidence.
Developers in headache disorders can comment on revised clinical trial requirements.
Developers can comment on clinical requirements for sickle cell disease products.
Developers can comment on clinical requirements for thalassaemia products.
Comments on planned revision of the hypertension clinical investigation guideline.
Comments on a planned guideline for trials in kidney transplant recipients.
Comments on the need for a guideline on inherited retinal dystrophy treatments.
Generic developers can comment on the bioequivalence approach for raltegravir.
Generic developers can comment on the bioequivalence approach for niraparib.
Generic developers can comment on the bioequivalence approach for semaglutide tablets.
PRAC plenary: safety signals, PSUSA outcomes, RMPs and referrals are discussed. MAHs should check the agenda for their substances and prepare for signal recommendations that may require label updates.
COMP plenary: orphan designation opinions and orphan maintenance reviews at MA. Relevant for sponsors of rare-disease products.
CAT plenary on advanced therapy medicinal products (ATMPs): draft opinions and ATMP classifications. Relevant mainly for gene, cell and tissue therapy developers.
CHMP plenary: new marketing authorisation opinions, extensions of indication and SmPC changes are adopted. MAHs with pending procedures should watch the highlights published at the end of the week.
PDCO plenary: paediatric investigation plans (PIPs), waivers and compliance checks are decided. Developers with PIP procedures should align submission timetables.
Generic/hybrid developers of nasal products can comment on equivalence requirements.
PRAC plenary: safety signals, PSUSA outcomes, RMPs and referrals are discussed. MAHs should check the agenda for their substances and prepare for signal recommendations that may require label updates.
CAT plenary on advanced therapy medicinal products (ATMPs): draft opinions and ATMP classifications. Relevant mainly for gene, cell and tissue therapy developers.
COMP plenary: orphan designation opinions and orphan maintenance reviews at MA. Relevant for sponsors of rare-disease products.
CHMP plenary: new marketing authorisation opinions, extensions of indication and SmPC changes are adopted. MAHs with pending procedures should watch the highlights published at the end of the week.
PDCO plenary: paediatric investigation plans (PIPs), waivers and compliance checks are decided. Developers with PIP procedures should align submission timetables.
Developers can comment on clinical investigation expectations in systemic sclerosis.
PRAC plenary: safety signals, PSUSA outcomes, RMPs and referrals are discussed. MAHs should check the agenda for their substances and prepare for signal recommendations that may require label updates.
COMP plenary: orphan designation opinions and orphan maintenance reviews at MA. Relevant for sponsors of rare-disease products.
CAT plenary on advanced therapy medicinal products (ATMPs): draft opinions and ATMP classifications. Relevant mainly for gene, cell and tissue therapy developers.
CHMP plenary: new marketing authorisation opinions, extensions of indication and SmPC changes are adopted. MAHs with pending procedures should watch the highlights published at the end of the week.
PDCO plenary: paediatric investigation plans (PIPs), waivers and compliance checks are decided. Developers with PIP procedures should align submission timetables.
PRAC plenary: safety signals, PSUSA outcomes, RMPs and referrals are discussed. MAHs should check the agenda for their substances and prepare for signal recommendations that may require label updates.
COMP plenary: orphan designation opinions and orphan maintenance reviews at MA. Relevant for sponsors of rare-disease products.
CAT plenary on advanced therapy medicinal products (ATMPs): draft opinions and ATMP classifications. Relevant mainly for gene, cell and tissue therapy developers.
ISPOR's annual international HEOR conference: value assessment, US pricing policy, real-world evidence. Colorado Convention Center, Denver.
CHMP plenary: new marketing authorisation opinions, extensions of indication and SmPC changes are adopted. MAHs with pending procedures should watch the highlights published at the end of the week.
PDCO plenary: paediatric investigation plans (PIPs), waivers and compliance checks are decided. Developers with PIP procedures should align submission timetables.
Legacy class B and sterile class A IVDs only benefit from the extended transition (to 31 Dec 2029) if a formal application to a notified body is lodged by this date.
End of the 18-month transition for registering MDR/IVDR certificates issued before 28 May 2026 in the EUDAMED Notified Bodies & Certificates module. Manufacturers should confirm with their notified body that all certificates are uploaded.
PRAC plenary: safety signals, PSUSA outcomes, RMPs and referrals are discussed. MAHs should check the agenda for their substances and prepare for signal recommendations that may require label updates.
COMP plenary: orphan designation opinions and orphan maintenance reviews at MA. Relevant for sponsors of rare-disease products.
CAT plenary on advanced therapy medicinal products (ATMPs): draft opinions and ATMP classifications. Relevant mainly for gene, cell and tissue therapy developers.
CHMP plenary: new marketing authorisation opinions, extensions of indication and SmPC changes are adopted. MAHs with pending procedures should watch the highlights published at the end of the week.
PDCO plenary: paediatric investigation plans (PIPs), waivers and compliance checks are decided. Developers with PIP procedures should align submission timetables.
PRAC plenary: safety signals, PSUSA outcomes, RMPs and referrals are discussed. MAHs should check the agenda for their substances and prepare for signal recommendations that may require label updates.
COMP plenary: orphan designation opinions and orphan maintenance reviews at MA. Relevant for sponsors of rare-disease products.
CAT plenary on advanced therapy medicinal products (ATMPs): draft opinions and ATMP classifications. Relevant mainly for gene, cell and tissue therapy developers.
CHMP plenary: new marketing authorisation opinions, extensions of indication and SmPC changes are adopted. MAHs with pending procedures should watch the highlights published at the end of the week.
PDCO plenary: paediatric investigation plans (PIPs), waivers and compliance checks are decided. Developers with PIP procedures should align submission timetables.
CAT plenary on advanced therapy medicinal products (ATMPs): draft opinions and ATMP classifications. Relevant mainly for gene, cell and tissue therapy developers.
PRAC plenary: safety signals, PSUSA outcomes, RMPs and referrals are discussed. MAHs should check the agenda for their substances and prepare for signal recommendations that may require label updates.
COMP plenary: orphan designation opinions and orphan maintenance reviews at MA. Relevant for sponsors of rare-disease products.
PDCO plenary: paediatric investigation plans (PIPs), waivers and compliance checks are decided. Developers with PIP procedures should align submission timetables.
CAT plenary on advanced therapy medicinal products (ATMPs): draft opinions and ATMP classifications. Relevant mainly for gene, cell and tissue therapy developers.
CHMP plenary: new marketing authorisation opinions, extensions of indication and SmPC changes are adopted. MAHs with pending procedures should watch the highlights published at the end of the week.
To keep the transition to 31 Dec 2029, manufacturers of legacy class B and sterile class A IVDs must have a signed written agreement with a notified body by this date.
PRAC plenary: safety signals, PSUSA outcomes, RMPs and referrals are discussed. MAHs should check the agenda for their substances and prepare for signal recommendations that may require label updates.
COMP plenary: orphan designation opinions and orphan maintenance reviews at MA. Relevant for sponsors of rare-disease products.
CAT plenary on advanced therapy medicinal products (ATMPs): draft opinions and ATMP classifications. Relevant mainly for gene, cell and tissue therapy developers.
CHMP plenary: new marketing authorisation opinions, extensions of indication and SmPC changes are adopted. MAHs with pending procedures should watch the highlights published at the end of the week.
PDCO plenary: paediatric investigation plans (PIPs), waivers and compliance checks are decided. Developers with PIP procedures should align submission timetables.
PRAC plenary: safety signals, PSUSA outcomes, RMPs and referrals are discussed. MAHs should check the agenda for their substances and prepare for signal recommendations that may require label updates.
CAT plenary on advanced therapy medicinal products (ATMPs): draft opinions and ATMP classifications. Relevant mainly for gene, cell and tissue therapy developers.
COMP plenary: orphan designation opinions and orphan maintenance reviews at MA. Relevant for sponsors of rare-disease products.
CHMP plenary: new marketing authorisation opinions, extensions of indication and SmPC changes are adopted. MAHs with pending procedures should watch the highlights published at the end of the week.
ISPOR's European HEOR and market-access conference. Allianz MiCo, Milan.
PDCO plenary: paediatric investigation plans (PIPs), waivers and compliance checks are decided. Developers with PIP procedures should align submission timetables.
PRAC plenary: safety signals, PSUSA outcomes, RMPs and referrals are discussed. MAHs should check the agenda for their substances and prepare for signal recommendations that may require label updates.
Following the Digital Omnibus on AI, obligations for stand-alone high-risk AI systems listed in Annex III apply from this date. Health organisations deploying such systems should complete risk-management and documentation work.
COMP plenary: orphan designation opinions and orphan maintenance reviews at MA. Relevant for sponsors of rare-disease products.
CAT plenary on advanced therapy medicinal products (ATMPs): draft opinions and ATMP classifications. Relevant mainly for gene, cell and tissue therapy developers.
CHMP plenary: new marketing authorisation opinions, extensions of indication and SmPC changes are adopted. MAHs with pending procedures should watch the highlights published at the end of the week.
PDCO plenary: paediatric investigation plans (PIPs), waivers and compliance checks are decided. Developers with PIP procedures should align submission timetables.
Last day legacy class III devices and most class IIb implantable devices can be placed on the market under the extended MDR transition, provided the 2024 application/agreement conditions were met. MDR certification must be in place after this.
Last day IVDs holding a Directive 98/79/EC certificate and class D IVDs without one may be placed on the market under the IVDR transition. IVDR certificates are needed after this date.
Medicines designated as orphan medicinal products become subject to EU joint clinical assessment. Sponsors should plan JCA dossiers and PICO scoping alongside the MAA.
ISPOR's annual international HEOR conference. Gaylord National Resort & Convention Center, National Harbor, Maryland.
High-risk AI obligations apply to AI embedded in products under Annex I EU harmonisation legislation (which includes medical devices and IVDs). AI-enabled device makers need AI Act conformity on top of MDR/IVDR.
ISPOR's European HEOR and market-access conference. Bella Center Copenhagen.
Last day other legacy class IIb, class IIa and certain class I devices can be placed on the market under the extended MDR transition, if conditions were met.
Last day legacy class C IVDs without a Directive certificate may be placed on the market under the IVDR transition.
All centrally authorised medicines in scope of Article 7(1) become subject to EU joint clinical assessment.
VigiEye subscribers get AI-summarised outcomes as each meeting publishes, a feed filtered to their markets and subjects, and a dated monitoring record they can export for audits and inspections.
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