En lægemiddelstrategi for EuropaLægemiddelstrategien for Europa (læsevenlig udgave), der blev vedtaget den 25. november 2020, har til formål at skabe et fremtidssikret regelsæt og…Legal frameworkThe EU legal framework for human medicines sets standards to ensure a high level of public health protection and the quality, safety and efficacy of…Medicines for ChildrenThe Paediatric Regulation has governed the development and authorisation of medicines for paediatric use since entering into force in 2007. Its…Orphan medicinal productsPatients suffering from rare diseases deserve the same quality of treatment as other patients within the European Union. Given the small numbers of…Advanced TherapiesAdvanced therapy refers to new medical products that use gene therapy, cell therapy, and tissue engineering. They can be used to treat diseases or…Pharmaceutical CommitteePharmaceutical Committee, Veterinary Pharmaceutical Committee. The Pharmaceutical Committee is an advisory Committee which was set up by Council…Clinical trialsClinical trials are scientifically controlled studies undertaken in humans to establish or confirm the safety and effectiveness of investigational…Falsified medicinesFalsified medicines are often disguised as authentic medicines but may contain ingredients of bad or toxic quality, or in the wrong dosage. As they…EU logoThe illegal sale of medicinal products via the Internet is a serious threat to public health and safety as falsified medicinal products may easily…Good Manufacturing and Distribution PracticesGood Manufacturing Practices (GMP). The manufacture or import of medicinal products is subject to manufacturing or import authorisation. The…PharmacovigilancePharmacovigilance is the process and science of monitoring the safety of medicines and taking action to reduce the risks and increase the benefits of…Herbal Medicinal ProductsEU legislation on pharmaceutical products for human use also applies to traditional herbal medicines. Herbal medicinal products are defined as any…Personalised medicinePersonalised medicine is a medical model that aims to provide tailor-made prevention and treatment strategies for defined groups of individuals…Pharmaceuticals and the EnvironmentEnvironmental Pollution caused by human and veterinary pharmaceutical substances is an emerging environmental problem. Article 8c of Directive 2008…Call for EMA committees and board membersOpen callsCivil Society representatives: Call for expressions of interest is open for the EMA Management Board. The Commission is launching a selection…LægemidlerEU er blandt de største i verden inden for medicinalindustrien og globalt set den førende inden for handel med lægemidler.Efterhånden som industrien…EudralexThe body of European Union legislation in the pharmaceutical sector is compiled in…Union RegisterThe Union Register lists all medicinal products for human and veterinary use as well as orphan medicinal products that have received a marketing… Latest updatesNews announcement19 Oktober 2022Biosimilar medicines - Multistakeholder Event (13 December 2022)News announcement17 Oktober 2022Staff Working Document on Vulnerabilities of the global supply chains of medicines – Structured Dialogue on the security of medicines supplyNews announcement12 Oktober 2022Agenda - 100th meeting of the Pharmaceutical Committee (21 October 2022)News announcement3 Oktober 2022Civil Society representatives: Call for expressions of interest for the EMA PDCO CommitteeSee all HighlightsStructured dialogue on security of medicines supplyEU Strategy on COVID-19 TherapeuticsEvaluation of the medicines for rare diseases and children legislationNotices to stakeholders - Withdrawal of the United Kingdom from the EULabelling and packaging flexibilities for COVID-19 vaccinesNotice to stakeholders - Questions and answers on regulatory expectations for medicinal products for human use during the covid-19 pandemic (updated 1 July 2020) Events13Dec.2022PartnermøderBiosimilar medicines - Multistakeholder Event03Feb.2022PartnermøderJoint action on support to coordinated and expedited assessment of clinical trials for COVID-19 therapeutics08Nov.2021PartnermøderJoint EMA/HMA-CTFG/COM training about IT support for safety cooperation in clinical trials16Jun.2021PartnermøderStructured Dialogue initiative - 2nd Event DocumentsEventsConsultationsPublicationsVideosEurobarometers
En lægemiddelstrategi for EuropaLægemiddelstrategien for Europa (læsevenlig udgave), der blev vedtaget den 25. november 2020, har til formål at skabe et fremtidssikret regelsæt og…
Legal frameworkThe EU legal framework for human medicines sets standards to ensure a high level of public health protection and the quality, safety and efficacy of…
Medicines for ChildrenThe Paediatric Regulation has governed the development and authorisation of medicines for paediatric use since entering into force in 2007. Its…
Orphan medicinal productsPatients suffering from rare diseases deserve the same quality of treatment as other patients within the European Union. Given the small numbers of…
Advanced TherapiesAdvanced therapy refers to new medical products that use gene therapy, cell therapy, and tissue engineering. They can be used to treat diseases or…
Pharmaceutical CommitteePharmaceutical Committee, Veterinary Pharmaceutical Committee. The Pharmaceutical Committee is an advisory Committee which was set up by Council…
Clinical trialsClinical trials are scientifically controlled studies undertaken in humans to establish or confirm the safety and effectiveness of investigational…
Falsified medicinesFalsified medicines are often disguised as authentic medicines but may contain ingredients of bad or toxic quality, or in the wrong dosage. As they…
EU logoThe illegal sale of medicinal products via the Internet is a serious threat to public health and safety as falsified medicinal products may easily…
Good Manufacturing and Distribution PracticesGood Manufacturing Practices (GMP). The manufacture or import of medicinal products is subject to manufacturing or import authorisation. The…
PharmacovigilancePharmacovigilance is the process and science of monitoring the safety of medicines and taking action to reduce the risks and increase the benefits of…
Herbal Medicinal ProductsEU legislation on pharmaceutical products for human use also applies to traditional herbal medicines. Herbal medicinal products are defined as any…
Personalised medicinePersonalised medicine is a medical model that aims to provide tailor-made prevention and treatment strategies for defined groups of individuals…
Pharmaceuticals and the EnvironmentEnvironmental Pollution caused by human and veterinary pharmaceutical substances is an emerging environmental problem. Article 8c of Directive 2008…
Call for EMA committees and board membersOpen callsCivil Society representatives: Call for expressions of interest is open for the EMA Management Board. The Commission is launching a selection…
LægemidlerEU er blandt de største i verden inden for medicinalindustrien og globalt set den førende inden for handel med lægemidler.Efterhånden som industrien…
Union RegisterThe Union Register lists all medicinal products for human and veterinary use as well as orphan medicinal products that have received a marketing…
News announcement17 Oktober 2022Staff Working Document on Vulnerabilities of the global supply chains of medicines – Structured Dialogue on the security of medicines supply
News announcement12 Oktober 2022Agenda - 100th meeting of the Pharmaceutical Committee (21 October 2022)
News announcement3 Oktober 2022Civil Society representatives: Call for expressions of interest for the EMA PDCO Committee
Notice to stakeholders - Questions and answers on regulatory expectations for medicinal products for human use during the covid-19 pandemic (updated 1 July 2020)
03Feb.2022PartnermøderJoint action on support to coordinated and expedited assessment of clinical trials for COVID-19 therapeutics
08Nov.2021PartnermøderJoint EMA/HMA-CTFG/COM training about IT support for safety cooperation in clinical trials
