New European regulations updating rules for medical devices enter into force
New European regulations updating medical device rules enter into force on 19 July 2026.
Portugal INFARMED · PortugalPortugal
Regulation
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INFARMED guidance on digital health solutions as medical devices
INFARMED publishes guidance clarifying the regulatory framework for digital health solutions including software, mobile applications and AI-based solutions as medical devices.
Portugal INFARMED · PortugalFrequently Asked Questions on SiNATS Review: First Answers Now Available
INFARMED publishes initial FAQ clarifying changes to Portugal's National Health Technology Assessment System (SiNATS) introduced by Decree-Law 118/2026.
Portugal INFARMED · PortugalReference Pricing System: Q4 2026
List of homogeneous groups and unit reference prices for Q4 2026 approved and effective 1 October 2026.
Portugal INFARMED · PortugalUpdate of lists under the Regulation on control of medicine transactions outside the country – September 2026
Lists annexed to the Regulation on prior notification of medicine transactions outside Portugal have been updated and enter into force the next business day after publication.
Portugal INFARMED · PortugalDispensing of prescription medicines: mandatory use of legally valid medical prescription
Joint informative circular on the mandatory use of legally valid medical prescriptions for dispensing prescription medicines.
Portugal INFARMED · PortugalReference Pricing System: Addition of new homogeneous groups (Q3 2026)
The list of homogeneous groups and unit reference prices for Q3 2026 under Portugal's reference pricing system has been updated.
Portugal INFARMED · PortugalReference Pricing System: Addition of new homogeneous groups (Q3 2026)
Portugal's INFARMED adds new homogeneous groups to the reference pricing system for the third quarter of 2026.
Portugal INFARMED · PortugalEU advances toward more ethical sunscreen testing methods
In vitro laboratory testing for sunscreen sun protection factor is reliable and more ethical than human volunteer testing involving UV-induced sunburn.
Portugal INFARMED · PortugalEuropean guidance for implementation of Shortage Prevention Plans
EMA publishes guidance and template for Shortage Prevention Plans required of marketing authorisation holders for prescription medicines.
Portugal INFARMED · PortugalInfarmed launches INOV@INFARMED innovation network and strengthens partnership between science and regulation
Infarmed established a structured collaboration network with academic institutions to advance research in medicines, medical devices, and health technology assessment.
Portugal INFARMED · PortugalNew study by INFARMED and EMA experts analyzes 13 years of clinical trials in Europe
A study by INFARMED and EMA experts analyzes the evolution of medicinal product clinical trials in the EU/EEA between 2013 and 2025 using CTIS and EudraCT data.
Portugal INFARMED · PortugalInfarmed launches digital campaign on condom acquisition safety
Infarmed runs a digital literacy campaign from September to 22 September on safe and informed purchase of condoms as medical devices.
Portugal INFARMED · PortugalEMA Executive Director visits Portugal, highlights Infarmed's role in European regulation
A Diretora Executiva da Agência Europeia de Medicamentos (EMA), Emer Cooke, encontra-se em Portugal para uma visita oficial de três dias que inclui encontros com o Infarmed e representantes do setor da saúde, e a part...
Portugal INFARMED · PortugalCOMBINE Programme advances to second phase of coordinated assessment pilot project for combined clinical trials
Portugal's INFARMED announces the COMBINE programme has progressed to the second phase of its pilot project for coordinated evaluation of combined clinical trials.
Portugal INFARMED · PortugalInfarmed publishes August 2026 performance indicators
SubscreverSubscrever Notícias O Infarmed disponibiliza indicadores relativos aomês de agosto, destacando algumas atividades que contribuem para garantir aos cidadãos a qualidade, segurança e eficácia dos medicamentos ...
Portugal INFARMED · PortugalINFARMED recruitment announcement: Laboratory Assistant positions
SubscreverSubscrever Notícias Queremos reforçar a nossa equipa e estamos à procura de pessoas para a função de Assistente de Laboratório, que desejem fazer parte dela. Para mais informação sobre este e outros concurso...
Portugal INFARMED · PortugalInfarmed management team meeting to reinforce priorities and prepare next steps
O Conselho Diretivo do Infarmed reuniu esta segunda-feira com os diretores, assessores e restante equipa alargada de gestão da instituição, num encontro de trabalho dedicado ao balanço da atividade e ao alinhamento da...
Portugal INFARMED · PortugalInfarmed publishes July 2026 performance indicators
O Infarmed disponibiliza indicadores relativos aomês de julho, destacando algumas atividades que contribuem para garantir aos cidadãos a qualidade, segurança e eficácia dos medicamentos e produtos de saúde, bem como a...
Portugal INFARMED · PortugalInfarmed updates data on medicinal cannabis sector activity
Data : 21/08/2026
Portugal INFARMED · PortugalNew edition of the Pharmacovigilance Bulletin
Volume 30, issues 5 and 6 (May and June 2026) of the Pharmacovigilance Bulletin is now available.
Portugal INFARMED · PortugalUpdate of lists under the Regulation on control of medicine transactions for export (August 2026)
Circular Informativa n.º 081/CD/100.20.200 de 30/07/2026
Portugal INFARMED · PortugalPortugal authorises first clinical trial in European FAST-EU pilot project
Portugal has authorised the first clinical trial under the European FAST-EU pilot project.
Portugal INFARMED · PortugalAlyftrek (deutivacaftor + tezacaftor + vanzacaftor) – Public funding evaluation report available
Alyftrek approved for hospital use in cystic fibrosis patients aged 6+ with non-Class I CFTR mutations; public evaluation report published.
Portugal INFARMED · PortugalKaftrio (Ivacaftor + Tezacaftor + Elexacaftor): Public funding evaluation report available
Kaftrio approved for hospital use in cystic fibrosis patients aged 2+ with non-F508del mutations; public evaluation report published.
Portugal INFARMED · PortugalAlhemo (Concizumab) – Public funding evaluation report available; positive preliminary assessment decision
Portugal's INFARMED has granted a positive preliminary assessment for public funding of Alhemo (Concizumab).
Portugal INFARMED · PortugalLoargys (pegzilarginase) – Public funding evaluation report available; reimbursement denied
INFARMED denied public reimbursement funding for Loargys (pegzilarginase); evaluation report available.
Portugal INFARMED · PortugalSkyrizi (Risancizumab): Public funding evaluation report available; prior assessment request approved
Skyrizi (risancizumab) approved for hospital use in moderate-to-severe active Crohn's disease in adults with inadequate response or intolerance to prior anti-TNF therapy.
Portugal INFARMED · PortugalElahere (mirvetuximab soravtansina) – Public funding evaluation report available; approval granted
Portugal's INFARMED has approved public funding for Elahere (mirvetuximab soravtansina); evaluation report now available.
Portugal INFARMED · PortugalEvkeeza (Evinacumab) – Public funding evaluation report available; reimbursement denied
INFARMED has issued a negative reimbursement decision for Evkeeza (evinacumab) in Portugal.
Portugal INFARMED · PortugalVoraxaze (glucarpidase) | Public funding evaluation report | Approval
Voraxaze (glucarpidase) approved for public funding in hospital use to reduce toxic plasma methotrexate concentration in adults and children aged ≥28 days.
Portugal INFARMED · PortugalNustendi (bempedoic acid + ezetimibe) – Public funding evaluation report available; reimbursement denied
INFARMED denied public reimbursement funding for Nustendi (bempedoic acid + ezetimibe) in Portugal.
Portugal INFARMED · PortugalNilemdo (bempedoic acid) – Public funding evaluation report available on Infomed – Rejection
Portugal's INFARMED rejected public funding for Nilemdo (bempedoic acid); evaluation report now available.
Portugal INFARMED · PortugalTrulicity (Dulaglutide): Public funding evaluation report available; reimbursement request approved
Portugal's INFARMED has approved public reimbursement funding for Trulicity (dulaglutide); evaluation report now available.
Portugal INFARMED · PortugalTevimbra (tislelizumab) – Public funding assessment report available; approval granted
Portugal's INFARMED has approved public funding for Tevimbra (tislelizumab) and published the assessment report.
Portugal INFARMED · PortugalOpzelura (ruxolitinib) – Public funding evaluation report available; approval granted
Portugal's INFARMED has approved public funding for Opzelura (ruxolitinib) following completion of the funding evaluation report.
Portugal INFARMED · PortugalOpdivo (nivolumab): Public funding evaluation reports available; approval of preliminary assessment requests
INFARMED has approved preliminary assessment requests for Opdivo (nivolumab) and made public funding evaluation reports available.
Portugal INFARMED · PortugalPiasky (Crovalimab) – Public funding evaluation report available; positive preliminary assessment decision
Portugal's INFARMED has granted a positive preliminary assessment for public funding of Piasky (crovalimab), with the evaluation report now available.
Portugal INFARMED · PortugalTryngolza (Olezarsen) – Public funding evaluation report available; positive preliminary assessment decision
INFARMED has granted a positive preliminary assessment for public funding of Tryngolza (Olezarsen).
Portugal INFARMED · PortugalJakavi (ruxolitinib) – Public funding evaluation report available; approval granted
Jakavi (ruxolitinib) approved for hospital use in acute and chronic graft-versus-host disease inadequately responsive to corticosteroids or systemic therapies in patients aged 12 years or older.
Portugal INFARMED · PortugalElrexfio (elranatamab) – Public funding evaluation report available; approval granted
Elrexfio (elranatamab) approved for hospital use in relapsed/refractory multiple myeloma after three prior therapies; public evaluation report published.
Portugal INFARMED · PortugalAdcetris (brentuximab vedotin) | Public funding evaluation report available on Infomed
Public funding evaluation report for Adcetris (brentuximab vedotin) is now available on the Infomed portal.
Portugal INFARMED · Portugal
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